An interventional study of TMS in Parkinson's Disease, Multiple System Atrophy and Progressive Supranuclear Palsy, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Peking University First Hospital · Not applicable, Interventional, and Treatment
This clinical trial aims to evaluate whether individualized targeted repetitive transcranial magnetic stimulation (rTMS) can improve motor and non-motor symptoms in patients with parkinsonian disorders. The main question it aims to answer is:
Procedures:
Parkinsonian disorders, including Parkinson's disease, multiple system atrophy, and progressive supranuclear palsy, are characterized by heterogeneous motor and non-motor manifestations that may respond incompletely to conventional pharmacological and rehabilitative treatments. Repetitive transcranial magnetic stimulation may provide a noninvasive approach to modulating dysfunctional brain networks. This study aims to evaluate the feasibility, safety, and potential clinical effects of individualized, network-guided repetitive transcranial magnetic stimulation in patients with parkinsonian disorders.
This is an ongoing, single-center, single-group, open-label interventional study comprising disease-specific cohorts of participants with Parkinson's disease, multiple system atrophy, and progressive supranuclear palsy. Individualized stimulation targets are identified using structural and functional magnetic resonance imaging, with particular attention to sites within the somato-cognitive action network. Participants receive intermittent theta burst stimulation according to the stimulation protocol specified in the intervention section of this record.
Clinical, neuroimaging, and neurophysiological assessments are performed before treatment, immediately after completion of treatment, and at the prespecified follow-up visit. Clinical assessments evaluate motor function, mobility, balance, ataxia, non-motor symptoms, autonomic symptoms, orthostatic blood pressure regulation, and urinary function, as applicable to each disease cohort. Magnetic resonance imaging and electroencephalography are used to explore treatment-related changes in brain network function. Medications and rehabilitation regimens are maintained as stable as clinically feasible during the treatment period.
An initial cohort of eight participants with multiple system atrophy was evaluated as an early, disease-specific pilot and exploratory analysis of the ongoing parent study. This analysis was conducted to assess treatment feasibility, safety, and preliminary clinical changes in the multiple system atrophy cohort. These participants form part of the overall study population and do not constitute a separate clinical trial. Recruitment and follow-up of the parent study are ongoing.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Peking University First Hospital is the lead sponsor of 390 studies on the registry; 186 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: TMS
Intermittent theta burst stimulation (iTBS) will be delivered using a figure-of-eight coil targeting the individualized somato-cognitive action network sites (involving superior and central region) in the left hemisphere. Stimulation intensity will be set at 100% of the resting motor threshold. The iTBS protocol will consist of bursts of 3 pulses at 50 Hz, repeated at 5 Hz. Each stimulation train include 10 bursts, with an inter-train interval of 8 seconds. A total of 60 trains will be delivered, resulting in 1800 pulses per session, with four consecutive sessions and a 50-minute interval between sessions, yielding 7200 pulses per target, and a total of 14,400 pulses per day, over ten consecutive working days.
Change in motor symptoms measured by MDS-UPDRS Part III
Motor symptoms will be assessed using the Movement Disorder Society-sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. The total score ranges from 0 to 132, with higher scores indicating more severe motor impairment and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame: Baseline to post-treatment and 10 weeks after treatment
Change in mobility measured by the 5-meter Timed Up and Go test
Mobility will be assessed using the 5-meter Timed Up and Go test. The result is recorded as the time in seconds required to stand up from a chair, walk 5 meters, turn around, walk back, and sit down. The theoretical minimum value is 0 seconds, and there is no fixed maximum value. A longer time indicates poorer mobility and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame: Baseline to post-treatment and 10 weeks after treatment
Change in non-motor symptoms measured by the Non-Motor Symptoms Questionnaire
Non-motor symptoms will be assessed using the Non-Motor Symptoms Questionnaire. The total score ranges from 0 to 30, with higher scores indicating a greater burden of non-motor symptoms and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame: Baseline to post-treatment and 10 weeks after treatment
Change in motor symptoms measured by UMSARS Part II
Motor impairment in patients with multiple system atrophy will be assessed using the Unified Multiple System Atrophy Rating Scale (UMSARS) Part II. The total score ranges from 0 to 56, with higher scores indicating more severe motor impairment and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame: Baseline to post-treatment and 10 weeks after treatment
Change in disease severity measured by PSPRS
Disease severity in patients with progressive supranuclear palsy will be assessed using the Progressive Supranuclear Palsy Rating Scale (PSPRS). The total score ranges from 0 to 100, with higher scores indicating greater disease severity and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame: Baseline to post-treatment and 10 weeks after treatment
Change in balance measured by the Berg Balance Scale
Balance function will be assessed using the Berg Balance Scale. The total score ranges from 0 to 56, with higher scores indicating better balance performance and a better outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame: Baseline to post-treatment and 10 weeks after treatment
Change in ataxia severity measured by SARA
Ataxia severity will be assessed using the Scale for the Assessment and Rating of Ataxia (SARA). The total score ranges from 0 to 40, with higher scores indicating more severe ataxia and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame: Baseline to post-treatment and 10 weeks after treatment
Change in autonomic symptoms measured by the COMPASS-31
Autonomic symptoms will be assessed using the Composite Autonomic Symptom Score 31 (COMPASS-31). The total weighted score ranges from 0 to 100, with higher scores indicating more severe autonomic symptoms and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame: Baseline to post-treatment and 10 weeks after treatment
Change in maximal systolic blood pressure drop during active standing
Orthostatic blood pressure regulation will be assessed using the maximal drop in systolic blood pressure during the active standing test. The value is measured in mmHg. There is no fixed maximum value; larger systolic blood pressure drops indicate more severe orthostatic blood pressure dysregulation and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame: Baseline to post-treatment and 10 weeks after treatment
Change in post-void residual volume
Urinary dysfunction will be assessed using post-void residual volume. The value is measured in milliliters. The minimum value is 0 mL, and there is no fixed maximum value. Higher post-void residual volume indicates greater urinary retention and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame: Baseline to post-treatment and 10 weeks after treatment
Plan to share: No — Individual participant data will not be shared due to privacy concerns and institutional regulations.
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Sep 2027, 21 months after the start.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 21 months is below that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
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