Parkinson DiseaseNCT06214377
Transcranial Direct Current Stimulation for Treating Parkinson´s Disease-related Pain in OFF State
A study testing Active Transcranial Direct Current Stimulation and Dopaminergic medication in people with Parkinson Disease and Pain, run by Universidad Francisco de Vitoria at 1 site in Spain.
Trial summary
Parkinson's Disease (PD) is a neurodegenerative disorder characterized by motor and non-motor symptoms. Pain is a significant symptom in PD, affecting a large percentage of patients and impacting their quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Pain
- What is being tested?
- Active Transcranial Direct Current Stimulation and Dopaminergic medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2023to 11 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Idiopathic Parkinson´s Disease.
- Presence of Parkinson´s Disease-related pain in the off-state.
- Neuroimaging study without previous pathologies.
- Score > 5 in transfers (bed to chair and back) item in Barthel Index.
- Score = or > 26 in Montreal Cognitive Assessment (MoCA).
- Tolerability for the application of electrotherapy.
- Able to provide informed consent to participate in the study
- Pain intensity >= 3 in Visual Analogue Scale or equivalent.
Who cannot join
- Neurologic disease different from PD.
- Pain non-related to PD.
- Dermatologic problems, wounds, or ulcers in the electrode's application area.
- Presence of implants or metal pieces in the head.
- Presence of cardiac pacemaker, vagal, brain or transcutaneous stimulators, medication pumps, ventriculoperitoneal shunts or aneurysm clips.
- Significative difficulties in language.
Show all 10Show fewer
- History of alcohol or drugs abuse.
- Non-controlled medical problems.
- Pregnancy.
- Epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) on Pain Modulation in Individuals With Parkinson's Disease in the Off State
Parkinson's Disease (PD) is a neurodegenerative disorder characterized by motor and non-motor symptoms. Pain is a significant symptom in PD, affecting a large percentage of patients and impacting their quality of life. The mechanisms of pain in PD involve complex changes in pain-modulating pathways, including dopaminergic and non-dopaminergic systems.
To address the lack of pain management strategies, the investigators propose exploring non-pharmacological therapies like transcranial direct current stimulation (tDCS). tDCS is a safe and non-invasive technique that modulates neuronal activity. It has shown positive effects on pain processing in healthy individuals and chronic pain patients, but its potential for PD-associated pain remains largely unexplored.
Read more
The primary motor cortex (M1) is a target for tDCS as it is believed to influence pain processing in other brain regions involved in sensory and emotional aspects. Initial studies suggest the benefits of tDCS in PD, including enhanced motor potentials and potential modulation of dopaminergic pathways. However, there are currently no published studies specifically investigating the effects of tDCS on PD-related pain, highlighting the need for further research.
A proof-of-concept trial is proposed to examine the effects of a single tDCS session on M1 in PD patients during the OFF state (without medication) and after taking dopaminergic medication. The study aims to assess the pain-relieving effects of tDCS in PD and explore potential synergies between tDCS and dopaminergic medication. By better understanding the impact of tDCS on pain relief in PD, this research may offer insights into alternative non-pharmacological approaches for managing pain in PD.
Read the detailed description
Parkinson's Disease (PD) is a complex progressive neurodegenerative disorder. It is the second most common neurodegenerative disease, with a prevalence of 4.1 to 4.6 million people over the age of 50. It is estimated that these numbers will increase to 8.7 to 9.3 million by the year 2030.
PD is multisystemic and include both motor and non-motor symptoms. These symptoms can fluctuate throughout the day, leading PD patients to frequently experience two distinct states: the "on" state, when dopaminergic medication is active in their system, and the "off" state, which occurs when there is no medication concentration in the body, resulting in more severe symptoms.
Pain in PD is a highly relevant symptom that significantly impacts patients' quality of life, with a prevalence of up to 85% and moderate to severe intensity reported in 42% of individuals. Additionally, in Spain, the prevalence of PD-associated pain has significantly increased following the COVID-19 pandemic, with up to 50% of PD patients reporting daily pain. Moreover, pain in PD is often underreported, emphasizing the need to investigate its mechanisms and treatment.
The pathophysiological mechanisms of pain in PD are complex. In general, PD can lead to alterations in peripheral transmission, sensory-discriminative processing, pain perception, and interpretation at multiple levels, due to neurodegenerative changes in both dopaminergic and non-dopaminergic pain-modulating pathways. This dysregulation of the dopaminergic system can impact the experience of pain directly by enhancing nociceptive signals and indirectly by influencing expectations and the interpretation of such signals. However, it is considered that there is no specific pain center in PD patients but rather a pain matrix involving various brain structures.
Given the multiple central structures affected and their consequent pathophysiological mechanisms in PD-associated pain, there is a wide variety of clinical manifestations. These include musculoskeletal pain, generalized central chronic pain, visceral pain, pain related to "on-off" fluctuations, dystonic-dyskinetic pain, nocturnal immobility-related pain or restless legs syndrome, orofacial pain, inflammation or edema-related pain, and radicular pain.
Regarding the assessment of pain in PD, there is only one specific scale that evaluates all pain phenotypes of the disease in terms of intensity and frequency, namely the King's Parkinson's Disease Pain Scale (KPPS). Therefore, due to the scarcity of objective pain assessment tools and the crucial role of the central nervous system and endogenous modulation systems in the origin of PD-associated pain, it is important to assess pain processing characteristics such as Conditioned Pain Modulation (CPM), and Pressure Pain Thresholds (PPTs). CPM assesses the descending inhibitory pain system, and PPTs assess the intensity of pressure required to elicit initial pain in a specific body area.
Dopaminergic medication is the primary treatment for PD symptoms; however, its effects on pain management have shown contradictory results according to recent systematic reviews. Moreover, there is currently a lack of robust evidence to establish guidelines for pain management in PD, which is why non-pharmacological therapies have been proposed as a safe and useful alternative with fewer side effects.
Transcranial Direct Current Stimulation (tDCS) is a non-invasive form of brain stimulation in which a relatively weak continuous current is delivered to the cortical areas through small electrodes placed on the scalp. It is a neuromodulatory intervention, and based on the assumption that the exposed tissue is polarized, tDCS would modulate neuronal excitability by depolarizing or hyperpolarizing the resting membrane potential of neurons. This modulation would result in increases or decreases in cortical excitability, depending on whether the active electrode is the anode or the cathode, respectively.
tDCS has been shown to have an effect on certain psychophysical variables of pain processing in healthy subjects. It has primarily been shown to enhance CPM and improvements have been reported in PPTs, cold and heat pain thresholds, acute pain induced by laser (26), and pain threshold after peripheral electrical stimulation. Importantly, tDCS has also demonstrated beneficial effects in patients with chronic pain. Specifically, it has shown improvements in pain processing characteristics, resulting in clinical pain improvements in other populations with chronic neuropathic pain. It is hypothesized that tDCS could be an effective alternative in the treatment of pain with central sensitization components, a process common in PD-associated pain.
The majority of the hypoalgesic effects generated by tDCS are due to its modulation of the primary motor cortex (M1). It is suggested that tDCS over M1 could reduce pain by increasing excitability not only in the stimulated area but also in other structures involved in pain processing, both sensory and emotional, through cortico-subcortical connectivity.
However, there are currently no published studies applying tDCS for the treatment of PD-associated pain, except for unpublished studies from our group confirming a favorable effect in this regard. Nonetheless, disregarding our results, its use can be considered safe as it has already been tested in PD patients for other purposes. tDCS has demonstrated an influence on Motor Evoked Potentials (MEPs) in PD patients, increasing MEPs after stimulating M1 with an active anode and decreasing MEPs with an active cathode. Furthermore, it has been observed that bilateral tDCS with an active anode leads to increases in BDNF, thus slowing down the degeneration of dopaminergic neurons. This last piece of evidence, along with other findings that demonstrate the capacity of tDCS to modulate dopaminergic transmission, is relevant for the present project, considering that part of the descending inhibitory pain system involves these pathways. Similarly, it has been demonstrated that pain causes reductions in corticomotor excitability, governed by M1, and tDCS applied to M1 has shown the ability to increase cortical excitability, which has abnormal activity in PD patients and could influence their pain.
Given the overlap between many influential areas in PD-associated pain and the areas excited by tDCS over M1, with these increases in excitability correlating with pain reduction, as well as the potential effect of tDCS on dopaminergic pathways, a hypoalgesic effect of tDCS in PD patients in their OFF state is hypothesized. Additionally, if the action is based on the activation of dopaminergic pathways, a possible enhancement of dopaminergic medication's action with better pain control during the ON period is also expected. However, there is currently no study that has specifically evaluated this effect in PD patients in the OFF state, making it pertinent to conduct a proof-of-concept trial with this objective. The objective is to determine the effect of a single session of treatment using transcranial direct current stimulation (tDCS) on the primary motor cortex (M1) on perceived clinical pain and pain processing characteristics in patients with Parkinson's disease (PD) in the OFF state (without dopaminergic medication) and after taking dopaminergic medication.
- Conditions
- Parkinson Disease, Pain
- Being tested
- Active Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation, Dopaminergic medication
- Keywords
- Parkinson Disease, Pain, tDCS, Off state, Motor fluctuations
- Medical subject headings
- Parkinson Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial Direct Current StimulationDevice
The Starstim tCS® equipment will be used, with 35 cm2 sponge electrodes. The tDCS over M1 will be performed by placing the active anode on the C3 point (10/20 EEG system) and the cathode on the contralateral supraorbital area (Fp2). Regarding the stimulated hemisphere, in cases of asymmetric pain, it will be applied to the contralateral M1, and in cases of bilateral pain, it will be applied to the M1 of the dominant hemisphere. A constant current of 2 mA (subthreshold intensity) will be applied for 20 minutes, with the first 30 seconds used as a ramp-up and the last 30 seconds as a ramp-down. Number of sessions: 1.
Sham Transcranial Direct Current StimulationDevice
The Starstim tCS® equipment (Neuroelectrics Inc, Barcelona, Spain) will be used with 35 cm2 sponge electrodes. The tDCS sham over M1 will be performed by placing the electrodes in the same position as in the active tDCS protocol. However, the stimulator will automatically turn off after 30 seconds of stimulation, making it a reliable sham stimulation method. Therefore, subjects will feel the same tingling sensation but will not receive current for the remainder of the stimulation time.
Dopaminergic medicationDrug
After tDCS, the participant will take their regular dopaminergic medication in order to go from OFF state to ON state.
| Study group | Role | What they receive |
|---|---|---|
| Active Transcranial Direct Current Stimulation and dopaminergic medication | Experimental | Active Transcranial Direct Current Stimulation (atDCS) will be applied over the Primary Motor Cortex (M1) contralateral to pain if it is unilateral, or always on the left M1 if pain is bilateral. It will consist of 1 session of 20 minutes of conventional stimulation (anode over M1) at 2 mA. It will be applied in the OFF state (i.e., >12h after the last medication intake). Lately, patients will take its usual dopaminergic medication. Receives: Device: Active Transcranial Direct Current Stimulation; Device: Sham Transcranial Direct Current Stimulation; Drug: Dopaminergic medication |
| : Sham Transcranial Direct Current Stimulation and dopaminergic medication | Sham comparator | Sham Transcranial Direct Current (s-tDCS) will be applied over the Primary Motor Cortex with the same procedure, during 1 session of 20 minutes of conventional stimulation. It will be applied in the OFF state (i.e., >12h after the last medication intake). Lately, patients will take its usual dopaminergic medication. Receives: Device: Active Transcranial Direct Current Stimulation; Device: Sham Transcranial Direct Current Stimulation; Drug: Dopaminergic medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Conditioned Pain Modulation
Assesses the descending pain modulatory system. The Pain Pressure Threshold will be assessed in the middle ofthe distal phalanx of the thumb with ta handheld algometer, corresponding to the first test stimulus. Afterward, the patient will immerse the contrary hand up to the wrist into stirred ice-cold water (0-4º) maintaining it for 3 minutes, corresponding to the conditioning stimulus. If the pain is unbearable before the 3 minutes, the patient will be able to remove his/her hand. Immediately after removing the hand, a second Pain Pressure Threshold measure will be performed in the same place as the first one, corresponding to the second test stimulus. After 1-minute rest, a third Pain Pressure Threshold will be measured to assess the Conditioned Pain Modulation residual functioning.
Measured: From baseline to immediately post tDCS
Change in Conditioned Pain Modulation
Assesses the descending pain modulatory system. The Pain Pressure Threshold will be assessed in the middle ofthe distal phalanx of the thumb with ta handheld algometer, corresponding to the first test stimulus. Afterward, the patient will immerse the contrary hand up to the wrist into stirred ice-cold water (0-4º) maintaining it for 3 minutes, corresponding to the conditioning stimulus. If the pain is unbearable before the 3 minutes, the patient will be able to remove his/her hand. Immediately after removing the hand, a second Pain Pressure Threshold measure will be performed in the same place as the first one, corresponding to the second test stimulus. After 1-minute rest, a third Pain Pressure Threshold will be measured to assess the Conditioned Pain Modulation residual functioning.
Measured: From baseline to immediately post dopaminergic medication
Changes in Pain Pressure Threshold
Two Pain Pressure Thresholds will be measured by a handheld algometer, one over the most painful area (peripheric hyperalgesia) and the other one over the middle of the distal phalanx of the thumb (central hyperalgesia). The Pain Pressure Threshold will be applied with the algometer perpendicular to the skin increasing at a rate of 1 kg/s until the first sensation of pain. 3 measures with 30-seconds rest between pulses will be performed, taking the average as Pain.
Pressure Threshold.
Measured: From baseline to immediately post tDCS
Changes in Pain Pressure Threshold
Two Pain Pressure Thresholds will be measured by a handheld algometer, one over the most painful area (peripheric hyperalgesia) and the other one over the middle of the distal phalanx of the thumb (central hyperalgesia). The Pain Pressure Threshold will be applied with the algometer perpendicular to the skin increasing at a rate of 1 kg/s until the first sensation of pain. 3 measures with 30-seconds rest between pulses will be performed, taking the average as Pain.
Pressure Threshold.
Measured: From baseline to immediately post dopaminergic medication
Changes in Visual Numeric Pain Rating Scale
It will be used to measure pain intensity due to its high discriminatory power. The scale assesses pain intensity using numbers or words through various types of scales ranging from 0 to 10. Pain rating ranges from 0 (no pain), 1-3 (mild pain, mild discomfort or irritation, slight impairment in daily activities), 4-6 (moderate pain, significant impairment in daily activities), and 7-10 (severe pain, inability to perform daily activities).
Measured: From baseline to immediately post tDCS
Changes in Visual Numeric Pain Rating Scale
It will be used to measure pain intensity due to its high discriminatory power. The scale assesses pain intensity using numbers or words through various types of scales ranging from 0 to 10. Pain rating ranges from 0 (no pain), 1-3 (mild pain, mild discomfort or irritation, slight impairment in daily activities), 4-6 (moderate pain, significant impairment in daily activities), and 7-10 (severe pain, inability to perform daily activities).
Measured: From baseline to immediately post dopaminergic medication
Changes in Global Rating of Change
It will be used to measure the self-perceived change in the patient's pain state. Its main objective is to quantify the extent to which a patient has improved or worsened over a specific period of time. It involves a single question asked to the patient to rate their change compared to the pre-intervention state, and the scores will range from -7 (much worse than before), through 0 (same as before), to +7 (much better than before).
Measured: From baseline to immediately post tDCS
Changes in Global Rating of Change
It will be used to measure the self-perceived change in the patient's pain state. Its main objective is to quantify the extent to which a patient has improved or worsened over a specific period of time. It involves a single question asked to the patient to rate their change compared to the pre-intervention state, and the scores will range from -7 (much worse than before), through 0 (same as before), to +7 (much better than before).
Measured: From baseline to immediately post dopaminergic medication
Secondary outcomes (4)
Changes in Brain Symmetry Index in electroencephalography
Resting state EEG: A 64-channel EEG recording will be performed at rest for 3 minutes following the standard protocol for baseline assessment.
Tapping EEG: A 64-channel EEG recording will be conducted while performing a tapping task for 30 seconds. The recording will be done separately for each hand, starting with the dominant hand.
Closed-Eyes EEG: A 64-channel EEG recording will be conducted while participants have their eyes closed for 5 minutes.
Measured: From baseline to immediately post tDCS
Changes in Brain Symmetry Index in electroencephalography
Resting EEG: A 64-channel EEG recording will be performed at rest for 3 minutes following the standard protocol for baseline assessment.
Tapping EEG: A 64-channel EEG recording will be conducted while performing a tapping task for 30 seconds. The recording will be done separately for each hand, starting with the dominant hand.
Closed-Eyes EEG: A 64-channel EEG recording will be conducted while participants have their eyes closed for 5 minutes.
Measured: From baseline to immediately post dopaminergic medication
Changes in Unified Parkinson´s Disease Rating Scale
It is a quantitative scale that collects information about the frequency and severity of motor symptoms. Higher scores indicate a greater degree of impairment. The minumum value is 0 and the maximum is 68.
Measured: From baseline to immediately post dopaminergic medication
Changes in Finger tapping task
Finger Taping task, where the participants will be instructed to press the space bar on the keyboard as fast as possible and repeatedly with the index finger, to measure motor function.
Measured: From baseline to immediately post dopaminergic medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Jul 2023
- Primary completion15 Mar 2024
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will be a triple-blinded experimental randomized controlled trial with a crossover design. The randomization will be conducted through the "GraphPad" software by an independent investigator. All the participants who fulfill the inclusion criteria and have none of the exclusion ones will be randomly allocated into two groups (depending on the order of the intervention allocation): 1.active-tDCS-2.shamtDCS or 1.sham-tDCS-2.active-tDCS. Allocation concealment will be ensured by the inclusion of the assigned group in closed opaque envelopes that will be opened at the time of the first intervention.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos, Hospital Beata María Ana
- Responsible party
- Sponsor
- Investigators
- Juan Pablo Romero, MD, PhD, Principal investigator, Universidad Francisco de Vitoria, Facultad de Ciencias ExperimentalesJosué Fernández Carnero, PT, PhD, Principal investigator, Universidad Rey Juan CarlosMarcos Moreno Verdú, PT, PhD, Principal investigator, Universidad Francisco de Vitoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214377
- Sponsor's protocol ID
- ParkOFF-tDCS
- Status last verified
- Jun 2023
- First submitted
- 29 Nov 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual anonymized participant data will be available to other researchers under request.
Publications
Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19.
PubMed 25904081Silverdale MA, Kobylecki C, Kass-Iliyya L, Martinez-Martin P, Lawton M, Cotterill S, Chaudhuri KR, Morris H, Baig F, Williams N, Hubbard L, Hu MT, Grosset DG; UK Parkinson's Pain Study Collaboration. A detailed clinical study of pain in 1957 participants with early/moderate Parkinson's disease. Parkinsonism Relat Disord. 2018 Nov;56:27-32. doi: 10.1016/j.parkreldis.2018.06.001. Epub 2018 Jun 6.
PubMed 29903584Antonini A, Tinazzi M, Abbruzzese G, Berardelli A, Chaudhuri KR, Defazio G, Ferreira J, Martinez-Martin P, Trenkwalder C, Rascol O. Pain in Parkinson's disease: facts and uncertainties. Eur J Neurol. 2018 Jul;25(7):917-e69. doi: 10.1111/ene.13624. Epub 2018 Apr 18.
PubMed 29520899Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
PubMed 27866120Fregni F, Boggio PS, Santos MC, Lima M, Vieira AL, Rigonatti SP, Silva MT, Barbosa ER, Nitsche MA, Pascual-Leone A. Noninvasive cortical stimulation with transcranial direct current stimulation in Parkinson's disease. Mov Disord. 2006 Oct;21(10):1693-702. doi: 10.1002/mds.21012.
PubMed 16817194Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA, Pascual-Leone A. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006 May;122(1-2):197-209. doi: 10.1016/j.pain.2006.02.023. Epub 2006 Mar 27.
PubMed 16564618Chaudhuri KR, Rizos A, Trenkwalder C, Rascol O, Pal S, Martino D, Carroll C, Paviour D, Falup-Pecurariu C, Kessel B, Silverdale M, Todorova A, Sauerbier A, Odin P, Antonini A, Martinez-Martin P; EUROPAR and the IPMDS Non Motor PD Study Group. King's Parkinson's disease pain scale, the first scale for pain in PD: An international validation. Mov Disord. 2015 Oct;30(12):1623-31. doi: 10.1002/mds.26270. Epub 2015 Jun 11.
PubMed 26096067Perez-Lloret S, Ciampi de Andrade D, Lyons KE, Rodriguez-Blazquez C, Chaudhuri KR, Deuschl G, Cruccu G, Sampaio C, Goetz CG, Schrag A, Martinez-Martin P, Stebbins G; Members of the MDS Committee on Rating Scales Development. Rating Scales for Pain in Parkinson's Disease: Critique and Recommendations. Mov Disord Clin Pract. 2016 Jun 24;3(6):527-537. doi: 10.1002/mdc3.12384. eCollection 2016 Nov-Dec.
PubMed 30363588Imai Y, Petersen KK, Morch CD, Arendt Nielsen L. Comparing test-retest reliability and magnitude of conditioned pain modulation using different combinations of test and conditioning stimuli. Somatosens Mot Res. 2016 Sep-Dec;33(3-4):169-177. doi: 10.1080/08990220.2016.1229178. Epub 2016 Sep 20.
PubMed 27650216Santos-Garcia D, Oreiro M, Perez P, Fanjul G, Paz Gonzalez JM, Feal Painceiras MJ, Cores Bartolome C, Valdes Aymerich L, Garcia Sancho C, Castellanos Rodrigo MDM. Impact of Coronavirus Disease 2019 Pandemic on Parkinson's Disease: A Cross-Sectional Survey of 568 Spanish Patients. Mov Disord. 2020 Oct;35(10):1712-1716. doi: 10.1002/mds.28261. Epub 2020 Sep 22.
PubMed 32776601Gonzalez-Zamorano Y, Moreno-Verdu M, Martinez-Benito A, Fernandez-Carnero J, Romero JP. Transcranial Direct Current Stimulation in Parkinson's Disease Patients in the Off State: A Randomized Controlled Crossover Trial Examining the Effects on Pain With and Without the Influence of Dopaminergic Medication. Pain Pract. 2025 Nov;25(8):e70082. doi: 10.1111/papr.70082.
PubMed 41039704
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation (tDCS) on Pain Modulation in Individuals With Parkinson's Disease in the Off State
- ClinicalTrials.gov ID
- NCT06214377
- Acronym / sponsor ID
- ParkOFF-tDCS
- Conditions
- Parkinson Disease, Pain
- Keywords
- Parkinson Disease, Pain, tDCS, Off state, Motor fluctuations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos, Hospital Beata María Ana
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parkinson's Disease (PD) is a neurodegenerative disorder characterized by motor and non-motor symptoms. Pain is a significant symptom in PD, affecting a large percentage of patients and impacting their quality of life. The mechanisms of pain in PD involve complex changes in pain-modulating pathways, including dopaminergic and non-dopaminergic systems.
To address the lack of pain management strategies, the investigators propose exploring non-pharmacological therapies like transcranial direct current stimulation (tDCS). tDCS is a safe and non-invasive technique that modulates neuronal activity. It has shown positive effects on pain processing in healthy individuals and chronic pain patients, but its potential for PD-associated pain remains largely unexplored.
The primary motor cortex (M1) is a target for tDCS as it is believed to influence pain processing in other brain regions involved in sensory and emotional aspects. Initial studies suggest the benefits of tDCS in PD, including enhanced motor potentials and potential modulation of dopaminergic pathways. However, there are currently no published studies specifically investigating the effects of tDCS on PD-related pain, highlighting the need for further research.
A proof-of-concept trial is proposed to examine the effects of a single tDCS session on M1 in PD patients during the OFF state (without medication) and after taking dopaminergic medication. The study aims to assess the pain-relieving effects of tDCS in PD and explore potential synergies between tDCS and dopaminergic medication. By better understanding the impact of tDCS on pain relief in PD, this research may offer insights into alternative non-pharmacological approaches for managing pain in PD.
Detailed description
Parkinson's Disease (PD) is a complex progressive neurodegenerative disorder. It is the second most common neurodegenerative disease, with a prevalence of 4.1 to 4.6 million people over the age of 50. It is estimated that these numbers will increase to 8.7 to 9.3 million by the year 2030.
PD is multisystemic and include both motor and non-motor symptoms. These symptoms can fluctuate throughout the day, leading PD patients to frequently experience two distinct states: the "on" state, when dopaminergic medication is active in their system, and the "off" state, which occurs when there is no medication concentration in the body, resulting in more severe symptoms.
Pain in PD is a highly relevant symptom that significantly impacts patients' quality of life, with a prevalence of up to 85% and moderate to severe intensity reported in 42% of individuals. Additionally, in Spain, the prevalence of PD-associated pain has significantly increased following the COVID-19 pandemic, with up to 50% of PD patients reporting daily pain. Moreover, pain in PD is often underreported, emphasizing the need to investigate its mechanisms and treatment.
The pathophysiological mechanisms of pain in PD are complex. In general, PD can lead to alterations in peripheral transmission, sensory-discriminative processing, pain perception, and interpretation at multiple levels, due to neurodegenerative changes in both dopaminergic and non-dopaminergic pain-modulating pathways. This dysregulation of the dopaminergic system can impact the experience of pain directly by enhancing nociceptive signals and indirectly by influencing expectations and the interpretation of such signals. However, it is considered that there is no specific pain center in PD patients but rather a pain matrix involving various brain structures.
Given the multiple central structures affected and their consequent pathophysiological mechanisms in PD-associated pain, there is a wide variety of clinical manifestations. These include musculoskeletal pain, generalized central chronic pain, visceral pain, pain related to "on-off" fluctuations, dystonic-dyskinetic pain, nocturnal immobility-related pain or restless legs syndrome, orofacial pain, inflammation or edema-related pain, and radicular pain.
Regarding the assessment of pain in PD, there is only one specific scale that evaluates all pain phenotypes of the disease in terms of intensity and frequency, namely the King's Parkinson's Disease Pain Scale (KPPS). Therefore, due to the scarcity of objective pain assessment tools and the crucial role of the central nervous system and endogenous modulation systems in the origin of PD-associated pain, it is important to assess pain processing characteristics such as Conditioned Pain Modulation (CPM), and Pressure Pain Thresholds (PPTs). CPM assesses the descending inhibitory pain system, and PPTs assess the intensity of pressure required to elicit initial pain in a specific body area.
Dopaminergic medication is the primary treatment for PD symptoms; however, its effects on pain management have shown contradictory results according to recent systematic reviews. Moreover, there is currently a lack of robust evidence to establish guidelines for pain management in PD, which is why non-pharmacological therapies have been proposed as a safe and useful alternative with fewer side effects.
Transcranial Direct Current Stimulation (tDCS) is a non-invasive form of brain stimulation in which a relatively weak continuous current is delivered to the cortical areas through small electrodes placed on the scalp. It is a neuromodulatory intervention, and based on the assumption that the exposed tissue is polarized, tDCS would modulate neuronal excitability by depolarizing or hyperpolarizing the resting membrane potential of neurons. This modulation would result in increases or decreases in cortical excitability, depending on whether the active electrode is the anode or the cathode, respectively.
tDCS has been shown to have an effect on certain psychophysical variables of pain processing in healthy subjects. It has primarily been shown to enhance CPM and improvements have been reported in PPTs, cold and heat pain thresholds, acute pain induced by laser (26), and pain threshold after peripheral electrical stimulation. Importantly, tDCS has also demonstrated beneficial effects in patients with chronic pain. Specifically, it has shown improvements in pain processing characteristics, resulting in clinical pain improvements in other populations with chronic neuropathic pain. It is hypothesized that tDCS could be an effective alternative in the treatment of pain with central sensitization components, a process common in PD-associated pain.
The majority of the hypoalgesic effects generated by tDCS are due to its modulation of the primary motor cortex (M1). It is suggested that tDCS over M1 could reduce pain by increasing excitability not only in the stimulated area but also in other structures involved in pain processing, both sensory and emotional, through cortico-subcortical connectivity.
However, there are currently no published studies applying tDCS for the treatment of PD-associated pain, except for unpublished studies from our group confirming a favorable effect in this regard. Nonetheless, disregarding our results, its use can be considered safe as it has already been tested in PD patients for other purposes. tDCS has demonstrated an influence on Motor Evoked Potentials (MEPs) in PD patients, increasing MEPs after stimulating M1 with an active anode and decreasing MEPs with an active cathode. Furthermore, it has been observed that bilateral tDCS with an active anode leads to increases in BDNF, thus slowing down the degeneration of dopaminergic neurons. This last piece of evidence, along with other findings that demonstrate the capacity of tDCS to modulate dopaminergic transmission, is relevant for the present project, considering that part of the descending inhibitory pain system involves these pathways. Similarly, it has been demonstrated that pain causes reductions in corticomotor excitability, governed by M1, and tDCS applied to M1 has shown the ability to increase cortical excitability, which has abnormal activity in PD patients and could influence their pain.
Given the overlap between many influential areas in PD-associated pain and the areas excited by tDCS over M1, with these increases in excitability correlating with pain reduction, as well as the potential effect of tDCS on dopaminergic pathways, a hypoalgesic effect of tDCS in PD patients in their OFF state is hypothesized. Additionally, if the action is based on the activation of dopaminergic pathways, a possible enhancement of dopaminergic medication's action with better pain control during the ON period is also expected. However, there is currently no study that has specifically evaluated this effect in PD patients in the OFF state, making it pertinent to conduct a proof-of-concept trial with this objective. The objective is to determine the effect of a single session of treatment using transcranial direct current stimulation (tDCS) on the primary motor cortex (M1) on perceived clinical pain and pain processing characteristics in patients with Parkinson's disease (PD) in the OFF state (without dopaminergic medication) and after taking dopaminergic medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be a triple-blinded experimental randomized controlled trial with a crossover design. The randomization will be conducted through the "GraphPad" software by an independent investigator. All the participants who fulfill the inclusion criteria and have none of the exclusion ones will be randomly allocated into two groups (depending on the order of the intervention allocation): 1.active-tDCS-2.shamtDCS or 1.sham-tDCS-2.active-tDCS. Allocation concealment will be ensured by the inclusion of the assigned group in closed opaque envelopes that will be opened at the time of the first intervention.
| Arm | Type | Receives |
|---|---|---|
| Active Transcranial Direct Current Stimulation and dopaminergic medication | Experimental | Device: Active Transcranial Direct Current Stimulation, Device: Sham Transcranial Direct Current Stimulation, Drug: Dopaminergic medicationActive Transcranial Direct Current Stimulation (atDCS) will be applied over the Primary Motor Cortex (M1) contralateral to pain if it is unilateral, or always on the left M1 if pain is bilateral. It will consist of 1 session of 20 minutes of conventional stimulation (anode over M1) at 2 mA. It will be applied in the OFF state (i.e., >12h after the last medication intake). Lately, patients will take its usual dopaminergic medication. |
| : Sham Transcranial Direct Current Stimulation and dopaminergic medication | Sham comparator | Device: Active Transcranial Direct Current Stimulation, Device: Sham Transcranial Direct Current Stimulation, Drug: Dopaminergic medicationSham Transcranial Direct Current (s-tDCS) will be applied over the Primary Motor Cortex with the same procedure, during 1 session of 20 minutes of conventional stimulation. It will be applied in the OFF state (i.e., >12h after the last medication intake). Lately, patients will take its usual dopaminergic medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of Idiopathic Parkinson´s Disease.
- Presence of Parkinson´s Disease-related pain in the off-state.
- Neuroimaging study without previous pathologies.
- Score > 5 in transfers (bed to chair and back) item in Barthel Index.
- Score = or > 26 in Montreal Cognitive Assessment (MoCA).
Key exclusion criteria (10 listed)
- Neurologic disease different from PD.
- Pain non-related to PD.
- Dermatologic problems, wounds, or ulcers in the electrode's application area.
- Presence of implants or metal pieces in the head.
- Presence of cardiac pacemaker, vagal, brain or transcutaneous stimulators, medication pumps, ventriculoperitoneal shunts or aneurysm clips.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Transcranial Direct Current StimulationThe Starstim tCS® equipment will be used, with 35 cm2 sponge electrodes. The tDCS over M1 will be performed by placing the active anode on the C3 point (10/20 EEG system) and the cathode on the contralateral supraorbital area (Fp2). Regarding the stimulated hemisphere, in cases of asymmetric pain, it will be applied to the contralateral M1, and in cases of bilateral pain, it will be applied to the M1 of the dominant hemisphere. A constant current of 2 mA (subthreshold intensity) will be applied for 20 minutes, with the first 30 seconds used as a ramp-up and the last 30 seconds as a ramp-down. Number of sessions: 1. | Device | : Sham Transcranial Direct Current Stimulation and dopaminergic medication, Active Transcranial Direct Current Stimulation and dopaminergic medication |
| Sham Transcranial Direct Current StimulationThe Starstim tCS® equipment (Neuroelectrics Inc, Barcelona, Spain) will be used with 35 cm2 sponge electrodes. The tDCS sham over M1 will be performed by placing the electrodes in the same position as in the active tDCS protocol. However, the stimulator will automatically turn off after 30 seconds of stimulation, making it a reliable sham stimulation method. Therefore, subjects will feel the same tingling sensation but will not receive current for the remainder of the stimulation time. | Device | : Sham Transcranial Direct Current Stimulation and dopaminergic medication, Active Transcranial Direct Current Stimulation and dopaminergic medication |
| Dopaminergic medicationAfter tDCS, the participant will take their regular dopaminergic medication in order to go from OFF state to ON state. | Drug | : Sham Transcranial Direct Current Stimulation and dopaminergic medication, Active Transcranial Direct Current Stimulation and dopaminergic medication |
Primary outcome
Change in Conditioned Pain Modulation
Time frame: From baseline to immediately post tDCS
Assesses the descending pain modulatory system. The Pain Pressure Threshold will be assessed in the middle ofthe distal phalanx of the thumb with ta handheld algometer, corresponding to the first test stimulus. Afterward, the patient will immerse the contrary hand up to the wrist into stirred ice-cold water (0-4º) maintaining it for 3 minutes, corresponding to the conditioning stimulus. If the pain is unbearable before the 3 minutes, the patient will be able to remove his/her hand. Immediately after removing the hand, a second Pain Pressure Threshold measure will be performed in the same place as the first one, corresponding to the second test stimulus. After 1-minute rest, a third Pain Pressure Threshold will be measured to assess the Conditioned Pain Modulation residual functioning.
Change in Conditioned Pain Modulation
Time frame: From baseline to immediately post dopaminergic medication
Assesses the descending pain modulatory system. The Pain Pressure Threshold will be assessed in the middle ofthe distal phalanx of the thumb with ta handheld algometer, corresponding to the first test stimulus. Afterward, the patient will immerse the contrary hand up to the wrist into stirred ice-cold water (0-4º) maintaining it for 3 minutes, corresponding to the conditioning stimulus. If the pain is unbearable before the 3 minutes, the patient will be able to remove his/her hand. Immediately after removing the hand, a second Pain Pressure Threshold measure will be performed in the same place as the first one, corresponding to the second test stimulus. After 1-minute rest, a third Pain Pressure Threshold will be measured to assess the Conditioned Pain Modulation residual functioning.
Changes in Pain Pressure Threshold
Time frame: From baseline to immediately post tDCS
Two Pain Pressure Thresholds will be measured by a handheld algometer, one over the most painful area (peripheric hyperalgesia) and the other one over the middle of the distal phalanx of the thumb (central hyperalgesia). The Pain Pressure Threshold will be applied with the algometer perpendicular to the skin increasing at a rate of 1 kg/s until the first sensation of pain. 3 measures with 30-seconds rest between pulses will be performed, taking the average as Pain. Pressure Threshold.
Changes in Pain Pressure Threshold
Time frame: From baseline to immediately post dopaminergic medication
Two Pain Pressure Thresholds will be measured by a handheld algometer, one over the most painful area (peripheric hyperalgesia) and the other one over the middle of the distal phalanx of the thumb (central hyperalgesia). The Pain Pressure Threshold will be applied with the algometer perpendicular to the skin increasing at a rate of 1 kg/s until the first sensation of pain. 3 measures with 30-seconds rest between pulses will be performed, taking the average as Pain. Pressure Threshold.
Changes in Visual Numeric Pain Rating Scale
Time frame: From baseline to immediately post tDCS
It will be used to measure pain intensity due to its high discriminatory power. The scale assesses pain intensity using numbers or words through various types of scales ranging from 0 to 10. Pain rating ranges from 0 (no pain), 1-3 (mild pain, mild discomfort or irritation, slight impairment in daily activities), 4-6 (moderate pain, significant impairment in daily activities), and 7-10 (severe pain, inability to perform daily activities).
Changes in Visual Numeric Pain Rating Scale
Time frame: From baseline to immediately post dopaminergic medication
It will be used to measure pain intensity due to its high discriminatory power. The scale assesses pain intensity using numbers or words through various types of scales ranging from 0 to 10. Pain rating ranges from 0 (no pain), 1-3 (mild pain, mild discomfort or irritation, slight impairment in daily activities), 4-6 (moderate pain, significant impairment in daily activities), and 7-10 (severe pain, inability to perform daily activities).
Changes in Global Rating of Change
Time frame: From baseline to immediately post tDCS
It will be used to measure the self-perceived change in the patient's pain state. Its main objective is to quantify the extent to which a patient has improved or worsened over a specific period of time. It involves a single question asked to the patient to rate their change compared to the pre-intervention state, and the scores will range from -7 (much worse than before), through 0 (same as before), to +7 (much better than before).
Changes in Global Rating of Change
Time frame: From baseline to immediately post dopaminergic medication
It will be used to measure the self-perceived change in the patient's pain state. Its main objective is to quantify the extent to which a patient has improved or worsened over a specific period of time. It involves a single question asked to the patient to rate their change compared to the pre-intervention state, and the scores will range from -7 (much worse than before), through 0 (same as before), to +7 (much better than before).
4 secondary outcomes
Changes in Brain Symmetry Index in electroencephalography
Time frame: From baseline to immediately post tDCS
Changes in Brain Symmetry Index in electroencephalography
Time frame: From baseline to immediately post dopaminergic medication
Changes in Unified Parkinson´s Disease Rating Scale
Time frame: From baseline to immediately post dopaminergic medication
Changes in Finger tapping task
Time frame: From baseline to immediately post dopaminergic medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Results publication: PubMed 25904081Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19.
- Results publication: PubMed 29903584Silverdale MA, Kobylecki C, Kass-Iliyya L, Martinez-Martin P, Lawton M, Cotterill S, Chaudhuri KR, Morris H, Baig F, Williams N, Hubbard L, Hu MT, Grosset DG; UK Parkinson's Pain Study Collaboration. A detailed clinical study of pain in 1957 participants with early/moderate Parkinson's disease. Parkinsonism Relat Disord. 2018 Nov;56:27-32. doi: 10.1016/j.parkreldis.2018.06.001. Epub 2018 Jun 6.
- Results publication: PubMed 29520899Antonini A, Tinazzi M, Abbruzzese G, Berardelli A, Chaudhuri KR, Defazio G, Ferreira J, Martinez-Martin P, Trenkwalder C, Rascol O. Pain in Parkinson's disease: facts and uncertainties. Eur J Neurol. 2018 Jul;25(7):917-e69. doi: 10.1111/ene.13624. Epub 2018 Apr 18.
- Results publication: PubMed 27866120Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
- Results publication: PubMed 16817194Fregni F, Boggio PS, Santos MC, Lima M, Vieira AL, Rigonatti SP, Silva MT, Barbosa ER, Nitsche MA, Pascual-Leone A. Noninvasive cortical stimulation with transcranial direct current stimulation in Parkinson's disease. Mov Disord. 2006 Oct;21(10):1693-702. doi: 10.1002/mds.21012.
- Results publication: PubMed 16564618Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA, Pascual-Leone A. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006 May;122(1-2):197-209. doi: 10.1016/j.pain.2006.02.023. Epub 2006 Mar 27.
- Results publication: PubMed 26096067Chaudhuri KR, Rizos A, Trenkwalder C, Rascol O, Pal S, Martino D, Carroll C, Paviour D, Falup-Pecurariu C, Kessel B, Silverdale M, Todorova A, Sauerbier A, Odin P, Antonini A, Martinez-Martin P; EUROPAR and the IPMDS Non Motor PD Study Group. King's Parkinson's disease pain scale, the first scale for pain in PD: An international validation. Mov Disord. 2015 Oct;30(12):1623-31. doi: 10.1002/mds.26270. Epub 2015 Jun 11.
- Results publication: PubMed 30363588Perez-Lloret S, Ciampi de Andrade D, Lyons KE, Rodriguez-Blazquez C, Chaudhuri KR, Deuschl G, Cruccu G, Sampaio C, Goetz CG, Schrag A, Martinez-Martin P, Stebbins G; Members of the MDS Committee on Rating Scales Development. Rating Scales for Pain in Parkinson's Disease: Critique and Recommendations. Mov Disord Clin Pract. 2016 Jun 24;3(6):527-537. doi: 10.1002/mdc3.12384. eCollection 2016 Nov-Dec.
- Results publication: PubMed 27650216Imai Y, Petersen KK, Morch CD, Arendt Nielsen L. Comparing test-retest reliability and magnitude of conditioned pain modulation using different combinations of test and conditioning stimuli. Somatosens Mot Res. 2016 Sep-Dec;33(3-4):169-177. doi: 10.1080/08990220.2016.1229178. Epub 2016 Sep 20.
- Results publication: PubMed 32776601Santos-Garcia D, Oreiro M, Perez P, Fanjul G, Paz Gonzalez JM, Feal Painceiras MJ, Cores Bartolome C, Valdes Aymerich L, Garcia Sancho C, Castellanos Rodrigo MDM. Impact of Coronavirus Disease 2019 Pandemic on Parkinson's Disease: A Cross-Sectional Survey of 568 Spanish Patients. Mov Disord. 2020 Oct;35(10):1712-1716. doi: 10.1002/mds.28261. Epub 2020 Sep 22.
- Derived from this study: PubMed 41039704Gonzalez-Zamorano Y, Moreno-Verdu M, Martinez-Benito A, Fernandez-Carnero J, Romero JP. Transcranial Direct Current Stimulation in Parkinson's Disease Patients in the Off State: A Randomized Controlled Crossover Trial Examining the Effects on Pain With and Without the Influence of Dopaminergic Medication. Pain Pract. 2025 Nov;25(8):e70082. doi: 10.1111/papr.70082.
- Individual participant dataSharing planned: Yes. Individual anonymized participant data will be available to other researchers under request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Pablo Romero, MD, PhD principal investigator
Universidad Francisco de Vitoria, Facultad de Ciencias Experimentales
Josué Fernández Carnero, PT, PhD principal investigator
Universidad Rey Juan Carlos
Marcos Moreno Verdú, PT, PhD principal investigator
Universidad Francisco de Vitoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcranial Direct Current Stimulation and Dopaminergic medication in people with Parkinson Disease and Pain, run by Universidad Francisco de Vitoria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Conditioned Pain Modulation (time frame: From baseline to immediately post tDCS). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06214377, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.