Parkinson's DiseaseNCT05537597
Repetitive Transcranial Magnetic Stimulation for Musculoskeletal Pain in Patients With Parkinson's Disease
A study testing active M1-rTMS in people with Parkinson's Disease and Musculoskeletal Pain, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Pain is an increasingly recognized non-motor symptom of Parkinson's disease (PD), with significant prevalence and negative impact on the quality of life of patients. Repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex（M1）has been proposed to provide definite analgesic effect for pain… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson's Disease, Musculoskeletal Pain, Repetitive Transcranial Magnetic Stimulation
- What is being tested?
- active M1-rTMS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic PD was diagnosed according to the 2015 Movement Disorder Society (MDS) clinical diagnostic criteria
- Hoehn and Yahr stages of I to III
- musculoskeletal pain was detected based on the Ford classification system for pain in PD. Pain duration of at least 3 months, with continuous moderate intensity pain (≥ 3/10 on a 0-10 numerical rating scale) occurring at least three days per week.
- stable antiparkinsonian therapy for ≥4 weeks
Who cannot join
- Contraindications to rTMS
- unstable ongoing psychiatric disorder, history of substance abuse (alcohol, drugs)
- histories of deep brain stimulation surgery
- Mini-mental State Examination scores ≤24
- Other pain conditions, such as apparent osteoarthritis, or rheumatoid arthritis depended on laboratory or imaging findings
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology, Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
About this study
Official title: Repetitive Transcranial Magnetic Stimulation for Musculoskeletal Pain in Patients With Parkinson's Disease：Efficacy and Safety, Electrophysiological Mechanisms and Influence on Motor and Other Non-motor Symptoms
Pain is an increasingly recognized non-motor symptom of Parkinson's disease (PD), with significant prevalence and negative impact on the quality of life of patients.
Repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex（M1）has been proposed to provide definite analgesic effect for pain syndromes. However, very few placebo-controlled studies have been performed specifically to relieve pain in PD. What's more, based on behavioral measures alone, it is impossible to reveal the full network dynamics reflecting the impact of TMS.
Read more
Electroencephalography (EEG), with high temporal resolution, records signal that its origin in electrical neural activity, which makes it suitable for measuring TMS-evoked activation. By recording the TMS induced neuronal activation directly from the cortex, TMS-EEG provides information on the excitability, effective connectivity of cortical area, thus exploring cortical network properties in different functional brain states. In addition, the use of EEG offers great prospects as a tool to select the right patients in order to achieve adequate, long-term pain relief.
Besides assessing the efficacy and safety of high-frequency neuronavigated M1-rTMS in PD patients with musculoskeletal pain, the objective of this study additionally aimed to characterize cortical activation behind pain relief. Influence on motor and other non-motor symptoms after rTMS were also investigated.
Read the detailed description
Pain can appear as a pre-motor symptom, and its intensity could be severe enough to be the dominant non-motor symptom in the course of PD patients.
It estimated the prevalence of painful phenomena in PD to be 30 to 85% (mean 66%), which is significantly greater than the age-matched general population. Painful experiences in PD are highly heterogeneous and complex, which is difficult to describe for patients but also diagnose for neurologists. In addition, this common and disabling symptom receives inadequate analgesic treatment.
The distinction between these pain subtypes is required so that different therapeutic strategies can be established for each type of pain. The King's Parkinson's Pain scale (KPPS) was validated to identify and rate the various types of pain in PD. Fourteen items cover seven main domains, including musculoskeletal pain, chronic body pain (central or visceral), fluctuation-related pain, dyskinetic-dystonic pain, nocturnal pain, oro-facial pain, discolouration/oedema/swelling, and radicular pain. Of these subtypes, musculoskeletal pain is common.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that may be useful for the treatment of various psychiatric and neurological disorders. The mechanisms underlying rTMS effects remain to be elucidated.
rTMS is postulated to induce neuronal excitability changes in a set of cortical and subcortical areas involved in pain processing and modulation. Interestingly, M1 stimulation had a positive effect on brain structures that are related to the affective-emotional components of pain, such as the insular cortex and cingulate cortex.
The best efficacy for chronic pain has been achieved when primary motor cortex (M1) is stimulated at high frequency (5 to 20 Hz, 80% of the resting motor threshold (RMT)), as in previous rTMS studies in analgesia.
In TMS, time-varying magnetic fields generates electrical currents in the cortex. TMS pulses can either directly or trans-synaptically depolarize neurons, and these neural activities can be recorded through the skull by EEG electrodes placed on the scalp. The combination of TMS with simultaneous EEG can be used to assess excitability, inhibition, plasticity and connectivity across almost all areas of the cortical mantle.
The characterization of potential TMS-EEG predictors and markers could be the theoretical basis for verifying the response to neuromodulation protocols.
In this randomised, double-blind, placebo-controlled study, the efficacy and safety of 7 sessions of 20 Hz-rTMS delivered to M1 will be assessed in PD patients with chronic musculoskeletal pain.
A single-pulse TMS-EEG and resting-state EEG directly provide information on the cortical mechanisms before and after rTMS of M1.
- Conditions
- Parkinson's Disease, Musculoskeletal Pain, Repetitive Transcranial Magnetic Stimulation, Primary Motor Cortex, Electroencephalography, Neuromodulation
- Being tested
- active M1-rTMS, sham rTMS
- Medical subject headings
- Parkinson Disease, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active M1-rTMSProcedure or surgery
Magnetic stimulation will be carried out using a MagPro X100 machine with a MCF-B70 figure-of-eight coil (Magventure, Farum). All rTMS sessions will be assisted by a neuronavigation system (TMS Navigator，Localite GmbH), maintaining the M1 target and the orientation of coil stable during stimulation sessions. The M1 target was defined as the "hand knob" region, which corresponds to the motor cortical representation of the hand, regardless of the location of pain.
Stimulation paradigm consists of 20 trains of pulses with an intra-train frequency of 20 Hz, resulting in 2000 pulses for a total duration of 20 minutes.
The stimulation intensity will be 80% of RMT, defined as the lowest stimulation intensity necessary to induce a visible muscle twitch of the hand contralateral to the stimulated hemisphere.
Participants will receive 7 sessions of treatment once a day in the same time continuously for 7 days, and keep antiparkinsonism drugs unchanged throughout the whole study.
sham rTMSProcedure or surgery
The sham protocol was similar to the rTMS protocol. Sham stimulations will be performed with a MCF-P-B65 figure-of-eight coil (Magventure) to M1, assisted by a neuronavigation system.
The following stimulation parameters will be used: stimulus frequency 20 Hz; stimulus intensity 80 % of RMT; total stimulation pulses 2,000; total stimulation time 20 min.
Participants will receive 7 sessions of treatment once a day in the same time continuously for 7 days, and keep antiparkinsonism drugs unchanged throughout the whole study.
| Study group | Role | What they receive |
|---|---|---|
| M1-rTMS group | Experimental | active M1-rTMS Receives: Procedure: active M1-rTMS |
| sham-rTMS group | Sham comparator | sham rTMS Receives: Procedure: sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Over 2 Months (Group by Time Interaction) in Modified KING'S PD Pain Scale Domain 1
Modified King's PD Pain Scale (MKPPS)，the modified version which is more suitable for Chinese people, combined with Ford's pain subtypes basing on the original. It covers five main domains, including 16 items, each item scored by severity (0-3) multiplied by frequency (0-4), resulting in a total possible score range from 0 to 192. Higher scores indicate greater symptom severities and more serious influence.
Measured: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Change From Baseline Over 2 Months (Group by Time Interaction) in KING'S PD Pain Scale Domain 1
KING'S PD Pain Scale (KPPS) Domain 1 focused on musculoskeletal pain, covering one item, which was scored by multiplying severity (from 0 [no pain] to 3 [very severe pain]) by frequency (from 0 [never] to 4 [all the time]), yielding sub-scores between 0 and 12. Higher scores indicate greater symptom severity.
Measured: before the first rTMS session (day 1), after rTMS therapy (day8、1month、2months)
Change in 0-10 Numeric Rating Scale
Pain intensity was assessed over the past 24 hours using a 0-10 number, where 0 indicating no pain and 10 indicating maximal pain.
Measured: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Secondary outcomes (11)
Changes in Resting-state EEG Oscillations
For each EEG epoch, we computed the fast Fourier transform (FFT) algorithm to convert to frequency domain. The power values in following five frequency bands were obtained: delta (1-4Hz), theta (4-8Hz), alpha(8-13Hz), beta(13-30Hz), gamma(30-80Hz).
Measured: before the first rTMS session (day 1), after rTMS therapy (day8)
Changes in Movement Disorder Society-Unified PD Rating Scale Part I
The participants will be evaluated in their "ON" medication states. The scale was used to assess the impact of non-motor symptoms on daily life, ranging from 0 to 52, with higher scores indicating more severe symptoms.
Measured: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Change in Movement Disorder Society-Unified PD Rating Scale Part II
The participants will be evaluated in their "ON" medication states. The scale was used to evaluate the patient's perspective on how motor symptoms impact their ability to perform daily activities, ranging from 0 to 52, with higher scores indicating more severe symptoms.
Measured: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Change in Movement Disorder Society-Unified PD Rating Scale Part III
The participants will be evaluated in their "ON" medication states. The scale was used to provide a quantitative, objective measure of motor signs, ranging from 0 to 132, with higher scores indicating more severe symptoms.
Measured: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Change in Movement Disorder Society-Unified PD Rating Scale Part IV
The participants will be evaluated in their "ON" medication states. The scale was used to document the presence and impact of motor fluctuations and dyskinesias, ranging from 0 to 24, with higher scores indicating more severe symptoms.
Measured: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Changes in Hamilton Depression Scale
The depression score (ranging from 0 to 76 with higher scores indicating more severe depression) from the 24 items Hamilton Depression Scale (HAMD).
Measured: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Changes in Hamilton Anxiety Scale
The anxiety score (ranging from 0 to 60 with higher scores indicating more severe anxiety) from the 14 items Hamilton Anxiety Scale (HAMA).
Measured: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Changes in PD Sleep Scale-2
The sleep problem index (from 0 to 68 with higher scores indicating more severe sleep problem) from the PD Sleep Scale-2 (PDSS-2).
Measured: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Changes in Epworth Sleeping Scale
The daytime sleepiness was assessed by the Epworth Sleeping Scale, which has a score range of 0-24, with higher scores indicating more severe symptoms.
Measured: before the first rTMS session (day 1), after rTMS therapy at day8、1month、2months
Changes in PD for Autonomic Symptoms
The Scale for Outcomes in Parkinson's disease for Autonomic Symptoms (SCOUP-AUT), which has a score range of 0-67, with higher scores indicating higher autonomic nervous system dysfunction.
Measured: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Changes in PD Questionnaire-39
We will also assess change in quality of life from the Parkinson's Disease Questionnaire-39 (PDQ-39), ranging from 0 to 156 with higher scores indicating more serious influence.
Measured: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Oct 2022
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)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
- Parallel groups
- Model description
- Patients will be randomised to receive either active or sham-rTMS according to a 2:1 ratio.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Jie Mao, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537597
- Sponsor's protocol ID
- JD-LK-2021-132-01
- Status last verified
- Jan 2026
- First submitted
- 2 Sep 2022
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valkovic P, Minar M, Singliarova H, Harsany J, Hanakova M, Martinkova J, Benetin J. Pain in Parkinson's Disease: A Cross-Sectional Study of Its Prevalence, Types, and Relationship to Depression and Quality of Life. PLoS One. 2015 Aug 26;10(8):e0136541. doi: 10.1371/journal.pone.0136541. eCollection 2015.
PubMed 26309254Silverdale 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 29903584Chaudhuri 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 26096067Picarelli H, Teixeira MJ, de Andrade DC, Myczkowski ML, Luvisotto TB, Yeng LT, Fonoff ET, Pridmore S, Marcolin MA. Repetitive transcranial magnetic stimulation is efficacious as an add-on to pharmacological therapy in complex regional pain syndrome (CRPS) type I. J Pain. 2010 Nov;11(11):1203-10. doi: 10.1016/j.jpain.2010.02.006. Epub 2010 Apr 28.
PubMed 20430702O'Connell NE, Marston L, Spencer S, DeSouza LH, Wand BM. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2018 Apr 13;4(4):CD008208. doi: 10.1002/14651858.CD008208.pub5.
PubMed 29652088Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
PubMed 31901449
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation for Musculoskeletal Pain in Patients With Parkinson's Disease：Efficacy and Safety, Electrophysiological Mechanisms and Influence on Motor and Other Non-motor Symptoms
- ClinicalTrials.gov ID
- NCT05537597
- Acronym / sponsor ID
- JD-LK-2021-132-01
- Conditions
- Parkinson's Disease, Musculoskeletal Pain, Repetitive Transcranial Magnetic Stimulation, Primary Motor Cortex, Electroencephalography, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Posted 17 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain is an increasingly recognized non-motor symptom of Parkinson's disease (PD), with significant prevalence and negative impact on the quality of life of patients.
Repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex（M1）has been proposed to provide definite analgesic effect for pain syndromes. However, very few placebo-controlled studies have been performed specifically to relieve pain in PD. What's more, based on behavioral measures alone, it is impossible to reveal the full network dynamics reflecting the impact of TMS.
Electroencephalography (EEG), with high temporal resolution, records signal that its origin in electrical neural activity, which makes it suitable for measuring TMS-evoked activation. By recording the TMS induced neuronal activation directly from the cortex, TMS-EEG provides information on the excitability, effective connectivity of cortical area, thus exploring cortical network properties in different functional brain states. In addition, the use of EEG offers great prospects as a tool to select the right patients in order to achieve adequate, long-term pain relief.
Besides assessing the efficacy and safety of high-frequency neuronavigated M1-rTMS in PD patients with musculoskeletal pain, the objective of this study additionally aimed to characterize cortical activation behind pain relief. Influence on motor and other non-motor symptoms after rTMS were also investigated.
Detailed description
Pain can appear as a pre-motor symptom, and its intensity could be severe enough to be the dominant non-motor symptom in the course of PD patients.
It estimated the prevalence of painful phenomena in PD to be 30 to 85% (mean 66%), which is significantly greater than the age-matched general population. Painful experiences in PD are highly heterogeneous and complex, which is difficult to describe for patients but also diagnose for neurologists. In addition, this common and disabling symptom receives inadequate analgesic treatment.
The distinction between these pain subtypes is required so that different therapeutic strategies can be established for each type of pain. The King's Parkinson's Pain scale (KPPS) was validated to identify and rate the various types of pain in PD. Fourteen items cover seven main domains, including musculoskeletal pain, chronic body pain (central or visceral), fluctuation-related pain, dyskinetic-dystonic pain, nocturnal pain, oro-facial pain, discolouration/oedema/swelling, and radicular pain. Of these subtypes, musculoskeletal pain is common.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that may be useful for the treatment of various psychiatric and neurological disorders. The mechanisms underlying rTMS effects remain to be elucidated.
rTMS is postulated to induce neuronal excitability changes in a set of cortical and subcortical areas involved in pain processing and modulation. Interestingly, M1 stimulation had a positive effect on brain structures that are related to the affective-emotional components of pain, such as the insular cortex and cingulate cortex.
The best efficacy for chronic pain has been achieved when primary motor cortex (M1) is stimulated at high frequency (5 to 20 Hz, 80% of the resting motor threshold (RMT)), as in previous rTMS studies in analgesia.
In TMS, time-varying magnetic fields generates electrical currents in the cortex. TMS pulses can either directly or trans-synaptically depolarize neurons, and these neural activities can be recorded through the skull by EEG electrodes placed on the scalp. The combination of TMS with simultaneous EEG can be used to assess excitability, inhibition, plasticity and connectivity across almost all areas of the cortical mantle.
The characterization of potential TMS-EEG predictors and markers could be the theoretical basis for verifying the response to neuromodulation protocols.
In this randomised, double-blind, placebo-controlled study, the efficacy and safety of 7 sessions of 20 Hz-rTMS delivered to M1 will be assessed in PD patients with chronic musculoskeletal pain.
A single-pulse TMS-EEG and resting-state EEG directly provide information on the cortical mechanisms before and after rTMS of M1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomised to receive either active or sham-rTMS according to a 2:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| M1-rTMS group | Experimental | Procedure: active M1-rTMSactive M1-rTMS |
| sham-rTMS group | Sham comparator | Procedure: sham rTMSsham rTMS |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Idiopathic PD was diagnosed according to the 2015 Movement Disorder Society (MDS) clinical diagnostic criteria
- Hoehn and Yahr stages of I to III
- musculoskeletal pain was detected based on the Ford classification system for pain in PD. Pain duration of at least 3 months, with continuous moderate intensity pain (≥ 3/10 on a 0-10 numerical rating scale) occurring at least three days per week.
- stable antiparkinsonian therapy for ≥4 weeks
Key exclusion criteria (5 listed)
- Contraindications to rTMS
- unstable ongoing psychiatric disorder, history of substance abuse (alcohol, drugs)
- histories of deep brain stimulation surgery
- Mini-mental State Examination scores ≤24
- Other pain conditions, such as apparent osteoarthritis, or rheumatoid arthritis depended on laboratory or imaging findings
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 M1-rTMSMagnetic stimulation will be carried out using a MagPro X100 machine with a MCF-B70 figure-of-eight coil (Magventure, Farum). All rTMS sessions will be assisted by a neuronavigation system (TMS Navigator，Localite GmbH), maintaining the M1 target and the orientation of coil stable during stimulation sessions. The M1 target was defined as the "hand knob" region, which corresponds to the motor cortical representation of the hand, regardless of the location of pain. Stimulation paradigm consists of 20 trains of pulses with an intra-train frequency of 20 Hz, resulting in 2000 pulses for a total duration of 20 minutes. The stimulation intensity will be 80% of RMT, defined as the lowest stimulation intensity necessary to induce a visible muscle twitch of the hand contralateral to the stimulated hemisphere. Participants will receive 7 sessions of treatment once a day in the same time continuously for 7 days, and keep antiparkinsonism drugs unchanged throughout the whole study. | Procedure or surgery | M1-rTMS group |
| sham rTMSThe sham protocol was similar to the rTMS protocol. Sham stimulations will be performed with a MCF-P-B65 figure-of-eight coil (Magventure) to M1, assisted by a neuronavigation system. The following stimulation parameters will be used: stimulus frequency 20 Hz; stimulus intensity 80 % of RMT; total stimulation pulses 2,000; total stimulation time 20 min. Participants will receive 7 sessions of treatment once a day in the same time continuously for 7 days, and keep antiparkinsonism drugs unchanged throughout the whole study. | Procedure or surgery | sham-rTMS group |
Primary outcome
Change From Baseline Over 2 Months (Group by Time Interaction) in Modified KING'S PD Pain Scale Domain 1
Time frame: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Modified King's PD Pain Scale (MKPPS)，the modified version which is more suitable for Chinese people, combined with Ford's pain subtypes basing on the original. It covers five main domains, including 16 items, each item scored by severity (0-3) multiplied by frequency (0-4), resulting in a total possible score range from 0 to 192. Higher scores indicate greater symptom severities and more serious influence.
Change From Baseline Over 2 Months (Group by Time Interaction) in KING'S PD Pain Scale Domain 1
Time frame: before the first rTMS session (day 1), after rTMS therapy (day8、1month、2months)
KING'S PD Pain Scale (KPPS) Domain 1 focused on musculoskeletal pain, covering one item, which was scored by multiplying severity (from 0 [no pain] to 3 [very severe pain]) by frequency (from 0 [never] to 4 [all the time]), yielding sub-scores between 0 and 12. Higher scores indicate greater symptom severity.
Change in 0-10 Numeric Rating Scale
Time frame: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Pain intensity was assessed over the past 24 hours using a 0-10 number, where 0 indicating no pain and 10 indicating maximal pain.
11 secondary outcomes
Changes in Resting-state EEG Oscillations
Time frame: before the first rTMS session (day 1), after rTMS therapy (day8)
Changes in Movement Disorder Society-Unified PD Rating Scale Part I
Time frame: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Change in Movement Disorder Society-Unified PD Rating Scale Part II
Time frame: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Change in Movement Disorder Society-Unified PD Rating Scale Part III
Time frame: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Change in Movement Disorder Society-Unified PD Rating Scale Part IV
Time frame: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Changes in Hamilton Depression Scale
Time frame: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Changes in Hamilton Anxiety Scale
Time frame: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Changes in PD Sleep Scale-2
Time frame: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Changes in Epworth Sleeping Scale
Time frame: before the first rTMS session (day 1), after rTMS therapy at day8、1month、2months
Changes in PD for Autonomic Symptoms
Time frame: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Changes in PD Questionnaire-39
Time frame: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26309254Valkovic P, Minar M, Singliarova H, Harsany J, Hanakova M, Martinkova J, Benetin J. Pain in Parkinson's Disease: A Cross-Sectional Study of Its Prevalence, Types, and Relationship to Depression and Quality of Life. PLoS One. 2015 Aug 26;10(8):e0136541. doi: 10.1371/journal.pone.0136541. eCollection 2015.
- Background: 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.
- Background: 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.
- Background: PubMed 20430702Picarelli H, Teixeira MJ, de Andrade DC, Myczkowski ML, Luvisotto TB, Yeng LT, Fonoff ET, Pridmore S, Marcolin MA. Repetitive transcranial magnetic stimulation is efficacious as an add-on to pharmacological therapy in complex regional pain syndrome (CRPS) type I. J Pain. 2010 Nov;11(11):1203-10. doi: 10.1016/j.jpain.2010.02.006. Epub 2010 Apr 28.
- Background: PubMed 29652088O'Connell NE, Marston L, Spencer S, DeSouza LH, Wand BM. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2018 Apr 13;4(4):CD008208. doi: 10.1002/14651858.CD008208.pub5.
- Background: PubMed 31901449Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
- Individual participant dataSharing planned: No
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 M1-rTMS in people with Parkinson's Disease and Musculoskeletal Pain, run by Second Affiliated Hospital of Soochow University at 1 site in China.
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 4 inclusion and 5 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 17 Feb 2026. 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 China. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline Over 2 Months (Group by Time Interaction) in Modified KING'S PD Pain Scale Domain 1 (time frame: before the first rTMS session (baseline), after rTMS therapy (day8、1month、2months)). The study lists 3 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 NCT05537597, which also lists 6 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 17 Feb 2026.