Parkinson's DiseaseNCT06840145
Biomarkers of Neurodegeneration and Neuroplasticity in Parkinson's Disease Patients Treated by Bilateral M1-iTBS
A study testing repetitive transcranial magnetic stimulation in people with Parkinson's Disease, run by Instituto de investigación e innovación biomédica de Cádiz at 1 site in Spain.
Trial summary
Intermittent theta-burst stimulation (iTBS) is a promising therapeutic option for Parkinson's disease patients. A study involving 24 patients will assess its effectiveness in alleviating clinical deficits. Patients will undergo 5 sessions of iTBS over the bilateral M1 and a 3-month washout period. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2022to 12 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with PD according to the UK Parkinson's Disease Society Brain Bank diagnostic criteria (UK PDSBB) diagnostic criteria
- Disease duration of at least 5 years to reduce the risk of including levodopa-responsive atypical Parkinsonism patients;
- Disease symptomatology in the ON medication state at a H\&Y scale of II-III;
- Clinical and therapeutic stability in the last 2 months previous to the recruitment period; and
- Aged 45-75 years.
Who cannot join
- Lack of a PD diagnosis that meets the UK PDSBB diagnostic criteria
- Presence of a serious systemic disease
- Presence of severe or moderate cognitive impairment comparable to dementia, as revealed by an MMP score of ≤ 24
- Any incapacitating psychiatric or other clinical condition that might affect the correct performance of this protocol, such as any dystonia and/or dyskinesia
- Patients who received amantadine within the previous 60 days
- Any sign of atypical parkinsonism, neurological comorbidities, or history of cranioencephalic traumatism or epilepsy or any other contraindication for receiving neurostimulation with TMS (e.g., intracranial magnetic implant, cardiac pacemaker)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers of Neurodegeneration and Neuroplasticity in Parkinson's Disease Patients Treated by Intermittent Theta-burst Stimulation Over the Bilateral Primary Motor Area: A Randomized, Double-blind, Sham-controlled, Crossover Trial Study
Intermittent theta-burst stimulation (iTBS) is a promising therapeutic option for Parkinson's disease patients. A study involving 24 patients will assess its effectiveness in alleviating clinical deficits. Patients will undergo 5 sessions of iTBS over the bilateral M1 and a 3-month washout period. Motor evaluation, neurocognitive assessment, serum biomarkers of neurodegeneration and neuroplasticity, and structural and functional MRI evaluations will be conducted at follow-up visits.
Read the detailed description
Background and objectives:
Intermittent theta-burst stimulation (iTBS) is a patterned form of excitatory transcranial magnetic stimulation that has yielded encouraging results as an adjunctive therapeutic option to alleviate the emergence of clinical deficits in Parkinson's disease (PD) patients. Although it has been demonstrated that iTBS influences dopamine-dependent cortico-striatal plasticity, little research has examined the neurobiological mechanisms underlying iTBS-induce clinical enhancement. Here, the primary goal is to verify whether iTBS bilaterally delivered over the primary motor cortex (M1) is effective at reducing both scoring motor functioning and non-motor symptoms in PD. The investigators hypothesize that these clinical improvements following bilateral M1-iTBS could be driven by endogenous dopamine release, which may rebalance cortical excitability and restore compensatory striatal volume changes, resulting in increased striatal-cortical-cerebellar functional connectivity, and positively impacting neuroglia and neuroplasticity modification.
Methods:
A total of 24 PD patients will be assessed in a crossover, randomized, double-blind, sham-controlled protocol study involving application of iTBS over the bilateral M1 (M1 iTBS). Patients on medication will be randomly assigned to receive real iTBS or control (sham) stimulation and will undergo 5 sessions (1 week) of iTBS over the bilateral M1 (1 week), a 3-month washout period, and then 5 sessions (1 week) of sham stimulation. Motor evaluation will be performed at different follow-up visits along with a comprehensive neurocognitive assessment, evaluation of M1 excitability, combined structural magnetic resonance imaging (MRI) and resting-state electroencephalography and functional MRI, and serum biomarker quantification of neuroaxonal damage, astrocytic reactivity, and neural plasticity prior to and after iTBS.
Discussion:
The findings of this study will help to update the efficiency of M1 iTBS for the treatment of PD and further provide specific neurobiological insights into improvements in motor and nonmotor symptoms in these patients. This novel project aims to yield more detailed structural and functional brain evaluations using a noninvasive approach, with the potential to identify prognostic neuroprotective biomarkers and elucidate structural and functional mechanisms of M1 iTBS-induced plasticity in cortico-basal ganglia circuitry. The current approach may significantly optimize neuromodulation paradigms to ensure state-of-the-art and scalable rehabilitative treatment to alleviate motor and nonmotor symptoms of PD.
- Conditions
- Parkinson's Disease
- Being tested
- repetitive transcranial magnetic stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationDevice
Also called rTMS, intermittent theta-burst stimulation, iTBS
Intermittent theta Burst stimulation will be performed as detailed in the Real arm description
| Study group | Role | What they receive |
|---|---|---|
| real iTBS | Active comparator | Intermittent theta burst stimulation (iTBS) will be performed using a 3 pulse bursts at 50 Hz repeated every 200 ms and delivered as short trains of 10 bursts lasting 2 s and an intertrain silence period of 8 s, for a total of 600 pulses (20 cycles of trains) and a total duration of 190 s. Intensity of iTBS will be administered to the bilateral M1 at 80% of the active motor threshold (aMT) of each patient. Receives: Device: repetitive transcranial magnetic stimulation |
| sham iTBS | Sham comparator | The repetitive transcranial magnetic stimulation (rTMS) coil stimulation will be applied in the same position of the real stimulation. Sham stimulation during treatment will follow the same procedure and both coils are identical in appearance and produce a similar sound and sensation, although the sham coil delivers no stimulation. The patient will hear the same sound of real stimulation, which will be only functionally inactive but will be completely performed (for the whole time of duration of stimulation) Receives: Device: repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical motor improvement
Movement Disorders Society (MDS) Unified Parkinson's Disease Rating Scale (UPDRS) Part III (MDS-UPDRS III). Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe.
Measured: Changes from baseline to immediately after stimulation, after 1 week, after 2 weeks, and after 4 weeks.
Changes on quality of life and motor complications
MDS-UPDRS (parts II - IV). Part II assessed motor experiences of daily living (Range 0-52). Part IV assessed motor complications and contained 6 items. Score range: 0-24, 4 and below is mild, 13 and above is severe
Measured: Changes from baseline to after stimulation.
Secondary outcomes (15)
Change in levodopa equivalent daily dose (LEDD)
Change in Levodopa and Dopamine Equivalent Daily Dosages (LEDD). The dosages of these medications are calculated using standardized conversion factors to obtain LEDD. This outcome aims to measure any changes in the daily dosages of these medications over the course of the study or intervention.
Measured: Changes from baseline to after stimulation
Change in the Parkinson's Fatigue Scale (PFS-16)
The PFS-16 is a 16-item patient-rated scale based on recent feelings and experiences over the past two weeks. Nine items address the impact of fatigue on daily functioning and activities, including socialization and work but not exercise specifically and seven items tap the presence or absence of the subjective experience of fatigue with an emphasis on the physical effects of fatigue. The scoring possibilities are 1 for "strongly disagree" and 5 for "strongly agree". Based on the total of the scores, an ordinal PFS score ranging from 16 to 80 will be applied.
Measured: Changes from baseline to after stimulation
Change in quality of life measured with the Parkinson Disease Questionnaire-39 (PDQ-39)
Mobility impact as assessed by PDQ-39 mobility dimension (questions #1-10 from the total PDQ-39 questionnaire). Scores are on a 0-4 Likert Scale (lower scores equaling better quality of life), summed, and then transformed into the total PDQ-39 that ranges from 0-100. Lower scores represent better quality of life.
Measured: Changes from baseline to after stimulation
Screening of cognitive function by MMP
Mini Mental Parkinson (MMP) is a brief questionnaire derived from the Mini Mental State Examination and used for the assessment of general cognitive function in PD patients. This test is evaluated on a maximum of 32 points. The presence of severe or moderate cognitive impairment comparable to dementia is indicated by a score of ≤ 24.
Measured: Changes from baseline to 2 weeks after stimulation
Screening of frontal lobe function related activities by Frontal Assessment Battery (FAB)
Frontal Assessment Battery (FAB) is a short battery consisting of 6 subtests related to different frontal lobe functions. The maximum score to be obtained in this test is 18 points. To consider that the subject presents alterations in the frontal lobe and, therefore, altered executive functions, his score must be equal to or less than 11 points.
Measured: Changes from baseline to after stimulation
Screening of visuospatial memory by Benton Visual Retention Test (BVRT)
Benton Visual Retention Test (BVRT) is a test used for the evaluation of visuospatial memory. In our protocol, we plan to use the multiple choice format of administration, which consists of stimulus presentation followed by concealment for immediate recognition of one item out of four answer options (specifically, the M form). The performance is scored 0-10 based on correct drawing reconstruction.
Measured: Changes from baseline to after stimulation
Beck Depression Inventory-II (BDI-II)
In the BDI-II, a score of 0-13 indicates absence of depression, 14-19 mild depression, 20-28 moderate depression, and 29-63 severe depression.
Measured: Changes from baseline to 2 weeks after stimulation
Hamilton Rating Scale for Anxiety (HAM-A)
In the HAM-A has a score range of 0 to 56, where higher scores are associated with higher severity anxiety.
Measured: Changes from baseline to 2 weeks after stimulation
Starkstein Apathy Scale (SAS)
The SAS has 14 items, rated on a 4-point scale with higher values indicating more apathy
Measured: Changes from baseline to 2 weeks after stimulation
Scale for the Evaluation of Neuropsychiatric Disorders in Parkinson's Disease (SEND-PD)
The SEND-PD is a 12-item scale divided into three subscales: psychotic symptoms, mood/apathy, and impulse control behaviors. Items are rated from 0 (not present) to 4 (very severe)
Measured: Changes from baseline to 2 weeks after stimulation
Parkinson's Psychosis Questionnaire (PPQ)
The PPQ is a screening tool used to measure the frequency and severity of early signs and psychotic symptoms of PD and consists of six items, each rated from 1 (no symptoms) to 4 (extreme symptoms); the total score ranges from 6 to 24 points.
Measured: Changes from baseline to 2 weeks after stimulation
Frontal Systems Behavior Scale (FrSBe)
The FrSBe is a self-report scale designed to assess the changes in behavior that may occur in relation to frontal system dysfunction. Each item is rated on a 1-5 Likert scale. Raw scores for the three subscales (Apathy, Disinhibition, and Executive Dysfunction) and the Total are reported as T scores.
Measured: Changes from baseline to 2 weeks after stimulation
Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease (QUIP)
The QUIP is a screening questionnaire developed for the assessment of Impulsive-Compulsive Disorders (ICDs) and related behaviors. It uses a 5-point Likert scale (score 0-4 for each question) to gauge the frequency of behaviors. Scores for each ICDs and related disorder range from 0 to 16 and the total QUIP score for all ICDs and related disorders combined ranges from 0 to 112, with a higher score indicating greater severity (ie, frequency) of symptoms.
Measured: Changes from baseline to 2 weeks after stimulation
Center for Neurologic Study-Lability Scale (CNS-LS)
The CNS-LS is a screening instrument composed of seven items that are scored by the patient according to the perceived frequency of pseudobulbar affect (PBA) episodes during the last week. A CNS-LS score of 13 or higher may suggest PBA.
Measured: Changes from baseline to 2 weeks after stimulation
Cortical excitability TMS-EMG measures
The following transcranial magnetic stimulation (TMS)-derived measures of cortical excitability using electromyography (EMG) parameters of cortical excitability will be obtained after stimulation of the first dorsal interosseous (FDI) muscle hotspot of the mapping grid: the resting motor threshold (rMT); the active motor threshold (aMT); twenty single pulses ("20t"); and the cortical silent period (cSP)
Measured: Changes from baseline to immediately after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Jun 2022
- Primary completion12 Feb 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's 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
- Each patient received both active and sham iTBS in randomized order in two different sessions, separated by at least 3 months. All patients will be tested four times: at baseline (pre-stimulation) and after iTBS (post-stimulation), both for active and sham iTBS. In each session, motor evaluation will be performed at different follow-up visits along with a comprehensive neurocognitive assessment, evaluation of M1 excitability, combined structural MRI and resting-state EEG and fMRI, and serum biomarker quantification of neuroaxonal damage, astrocytic reactivity, and neural plasticity prior to and after iTBS.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de investigación e innovación biomédica de Cádiz
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain, Andalusian Ministry of Health and Families, Andalusian Ministry of University, Research and Innovation, University of Cadiz, Hospital Universitario Puerta del Mar
- Responsible party
- Sponsor
- Investigators
- Javier J. Gonzalez-Rosa, PhD, Principal investigator, University of Cadiz & Institute of Biomedical Research Cadiz (INiBICA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840145
- Sponsor's protocol ID
- PD-iTBS-2169-N-19
- Status last verified
- Feb 2025
- First submitted
- 2 Sep 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymized raw data analyzed in the present study are available on reasonable request to the corresponding author for purposes of replicating procedures and results. The Results derived from the project will be published in clinical and neuroscience journals.
Publications
Rashid-Lopez R, Macias-Garcia P, Cruz-Gomez AJ, Cano-Cano F, Sanchez-Fernandez FL, Sarrias-Arrabal E, Del Marco A, Gonzalez-Moraleda A, Lozano-Soto E, Sanmartino F, Espinosa-Rosso R, Gonzalez-Rosa JJ. Plasticity-Induced Motor Recovery of Bilateral Intermittent Theta Burst Stimulation in Parkinson's Disease: A Randomized, Double-Blind, Sham-Controlled, Crossover Trial. Neurol Ther. 2026 Feb;15(1):345-366. doi: 10.1007/s40120-025-00865-0. Epub 2025 Dec 6.
PubMed 41351806
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Neurodegeneration and Neuroplasticity in Parkinson's Disease Patients Treated by Intermittent Theta-burst Stimulation Over the Bilateral Primary Motor Area: A Randomized, Double-blind, Sham-controlled, Crossover Trial Study
- ClinicalTrials.gov ID
- NCT06840145
- Acronym / sponsor ID
- PD-iTBS-2169-N-19
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Instituto de investigación e innovación biomédica de CádizUniversity, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain, Andalusian Ministry of Health and Families, Andalusian Ministry of University, Research and Innovation, University of Cadiz, Hospital Universitario Puerta del Mar
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 21 Feb 2025 (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.
Intermittent theta-burst stimulation (iTBS) is a promising therapeutic option for Parkinson's disease patients. A study involving 24 patients will assess its effectiveness in alleviating clinical deficits. Patients will undergo 5 sessions of iTBS over the bilateral M1 and a 3-month washout period. Motor evaluation, neurocognitive assessment, serum biomarkers of neurodegeneration and neuroplasticity, and structural and functional MRI evaluations will be conducted at follow-up visits.
Detailed description
Background and objectives:
Intermittent theta-burst stimulation (iTBS) is a patterned form of excitatory transcranial magnetic stimulation that has yielded encouraging results as an adjunctive therapeutic option to alleviate the emergence of clinical deficits in Parkinson's disease (PD) patients. Although it has been demonstrated that iTBS influences dopamine-dependent cortico-striatal plasticity, little research has examined the neurobiological mechanisms underlying iTBS-induce clinical enhancement. Here, the primary goal is to verify whether iTBS bilaterally delivered over the primary motor cortex (M1) is effective at reducing both scoring motor functioning and non-motor symptoms in PD. The investigators hypothesize that these clinical improvements following bilateral M1-iTBS could be driven by endogenous dopamine release, which may rebalance cortical excitability and restore compensatory striatal volume changes, resulting in increased striatal-cortical-cerebellar functional connectivity, and positively impacting neuroglia and neuroplasticity modification.
Methods:
A total of 24 PD patients will be assessed in a crossover, randomized, double-blind, sham-controlled protocol study involving application of iTBS over the bilateral M1 (M1 iTBS). Patients on medication will be randomly assigned to receive real iTBS or control (sham) stimulation and will undergo 5 sessions (1 week) of iTBS over the bilateral M1 (1 week), a 3-month washout period, and then 5 sessions (1 week) of sham stimulation. Motor evaluation will be performed at different follow-up visits along with a comprehensive neurocognitive assessment, evaluation of M1 excitability, combined structural magnetic resonance imaging (MRI) and resting-state electroencephalography and functional MRI, and serum biomarker quantification of neuroaxonal damage, astrocytic reactivity, and neural plasticity prior to and after iTBS.
Discussion:
The findings of this study will help to update the efficiency of M1 iTBS for the treatment of PD and further provide specific neurobiological insights into improvements in motor and nonmotor symptoms in these patients. This novel project aims to yield more detailed structural and functional brain evaluations using a noninvasive approach, with the potential to identify prognostic neuroprotective biomarkers and elucidate structural and functional mechanisms of M1 iTBS-induced plasticity in cortico-basal ganglia circuitry. The current approach may significantly optimize neuromodulation paradigms to ensure state-of-the-art and scalable rehabilitative treatment to alleviate motor and nonmotor symptoms of PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each patient received both active and sham iTBS in randomized order in two different sessions, separated by at least 3 months. All patients will be tested four times: at baseline (pre-stimulation) and after iTBS (post-stimulation), both for active and sham iTBS. In each session, motor evaluation will be performed at different follow-up visits along with a comprehensive neurocognitive assessment, evaluation of M1 excitability, combined structural MRI and resting-state EEG and fMRI, and serum biomarker quantification of neuroaxonal damage, astrocytic reactivity, and neural plasticity prior to and after iTBS.
| Arm | Type | Receives |
|---|---|---|
| real iTBS | Active comparator | Device: repetitive transcranial magnetic stimulationIntermittent theta burst stimulation (iTBS) will be performed using a 3 pulse bursts at 50 Hz repeated every 200 ms and delivered as short trains of 10 bursts lasting 2 s and an intertrain silence period of 8 s, for a total of 600 pulses (20 cycles of trains) and a total duration of 190 s. Intensity of iTBS will be administered to the bilateral M1 at 80% of the active motor threshold (aMT) of each patient. |
| sham iTBS | Sham comparator | Device: repetitive transcranial magnetic stimulationThe repetitive transcranial magnetic stimulation (rTMS) coil stimulation will be applied in the same position of the real stimulation. Sham stimulation during treatment will follow the same procedure and both coils are identical in appearance and produce a similar sound and sensation, although the sham coil delivers no stimulation. The patient will hear the same sound of real stimulation, which will be only functionally inactive but will be completely performed (for the whole time of duration of stimulation) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with PD according to the UK Parkinson's Disease Society Brain Bank diagnostic criteria (UK PDSBB) diagnostic criteria
- Disease duration of at least 5 years to reduce the risk of including levodopa-responsive atypical Parkinsonism patients;
- Disease symptomatology in the ON medication state at a H\&Y scale of II-III;
- Clinical and therapeutic stability in the last 2 months previous to the recruitment period; and
- Aged 45-75 years.
Key exclusion criteria (6 listed)
- Lack of a PD diagnosis that meets the UK PDSBB diagnostic criteria
- Presence of a serious systemic disease
- Presence of severe or moderate cognitive impairment comparable to dementia, as revealed by an MMP score of ≤ 24
- Any incapacitating psychiatric or other clinical condition that might affect the correct performance of this protocol, such as any dystonia and/or dyskinesia
- Patients who received amantadine within the previous 60 days
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 |
|---|---|---|
| repetitive transcranial magnetic stimulationAlso: rTMS, intermittent theta-burst stimulation, iTBSIntermittent theta Burst stimulation will be performed as detailed in the Real arm description | Device | real iTBS, sham iTBS |
Primary outcome
Clinical motor improvement
Time frame: Changes from baseline to immediately after stimulation, after 1 week, after 2 weeks, and after 4 weeks.
Movement Disorders Society (MDS) Unified Parkinson's Disease Rating Scale (UPDRS) Part III (MDS-UPDRS III). Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe.
Changes on quality of life and motor complications
Time frame: Changes from baseline to after stimulation.
MDS-UPDRS (parts II - IV). Part II assessed motor experiences of daily living (Range 0-52). Part IV assessed motor complications and contained 6 items. Score range: 0-24, 4 and below is mild, 13 and above is severe
15 secondary outcomes
Change in levodopa equivalent daily dose (LEDD)
Time frame: Changes from baseline to after stimulation
Change in the Parkinson's Fatigue Scale (PFS-16)
Time frame: Changes from baseline to after stimulation
Change in quality of life measured with the Parkinson Disease Questionnaire-39 (PDQ-39)
Time frame: Changes from baseline to after stimulation
Screening of cognitive function by MMP
Time frame: Changes from baseline to 2 weeks after stimulation
Screening of frontal lobe function related activities by Frontal Assessment Battery (FAB)
Time frame: Changes from baseline to after stimulation
Screening of visuospatial memory by Benton Visual Retention Test (BVRT)
Time frame: Changes from baseline to after stimulation
Beck Depression Inventory-II (BDI-II)
Time frame: Changes from baseline to 2 weeks after stimulation
Hamilton Rating Scale for Anxiety (HAM-A)
Time frame: Changes from baseline to 2 weeks after stimulation
Starkstein Apathy Scale (SAS)
Time frame: Changes from baseline to 2 weeks after stimulation
Scale for the Evaluation of Neuropsychiatric Disorders in Parkinson's Disease (SEND-PD)
Time frame: Changes from baseline to 2 weeks after stimulation
Parkinson's Psychosis Questionnaire (PPQ)
Time frame: Changes from baseline to 2 weeks after stimulation
Frontal Systems Behavior Scale (FrSBe)
Time frame: Changes from baseline to 2 weeks after stimulation
Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease (QUIP)
Time frame: Changes from baseline to 2 weeks after stimulation
Center for Neurologic Study-Lability Scale (CNS-LS)
Time frame: Changes from baseline to 2 weeks after stimulation
Cortical excitability TMS-EMG measures
Time frame: Changes from baseline to immediately after stimulation
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 21 Feb 2025.
- Derived from this study: PubMed 41351806Rashid-Lopez R, Macias-Garcia P, Cruz-Gomez AJ, Cano-Cano F, Sanchez-Fernandez FL, Sarrias-Arrabal E, Del Marco A, Gonzalez-Moraleda A, Lozano-Soto E, Sanmartino F, Espinosa-Rosso R, Gonzalez-Rosa JJ. Plasticity-Induced Motor Recovery of Bilateral Intermittent Theta Burst Stimulation in Parkinson's Disease: A Randomized, Double-Blind, Sham-Controlled, Crossover Trial. Neurol Ther. 2026 Feb;15(1):345-366. doi: 10.1007/s40120-025-00865-0. Epub 2025 Dec 6.
- Individual participant dataSharing planned: Yes. The anonymized raw data analyzed in the present study are available on reasonable request to the corresponding author for purposes of replicating procedures and results. The Results derived from the project will be published in clinical and neuroscience journals.
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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.
Javier J. Gonzalez-Rosa, PhD principal investigator
University of Cadiz & Institute of Biomedical Research Cadiz (INiBICA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation in people with Parkinson's Disease, run by Instituto de investigación e innovación biomédica de Cádiz 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 5 inclusion and 6 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 21 Feb 2025. 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?
Clinical motor improvement (time frame: Changes from baseline to immediately after stimulation, after 1 week, after 2 weeks, and after 4 weeks.). The study lists 2 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 NCT06840145, which also lists 1 linked publication.
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 21 Feb 2025.