Parkinson's DiseaseNCT07570212
Individualized Transcranial Magnetic Stimulation in Parkinsonian Disorders
A study testing TMS in people with Parkinson's Disease and Multiple System Atrophy, run by Peking University First Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2025to 22 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic Criteria Clinically established or clinically probable Parkinson's Disease (PD) according to the 2015 International Parkinson and Movement Disorder Society (MDS) diagnostic criteria; Clinically established or clinically probable Multiple System Atrophy (MSA) according to the 2022 MDS diagnostic criteria; Clinically probable or clinically possible Progressive Supranuclear Palsy (PSP) according to the 2017 MDS diagnostic criteria.
- Demographics Aged 30 to 80 years, inclusive; no gender restrictions.
- Disease Severity and Staging PD: Modified Hoehn and Yahr (H-Y) stage 2-4; MSA: Unified Multiple System Atrophy Rating Scale (UMSARS) Part IV stage 1-4; PSP: Modified Rankin Scale (mRS) grade 2-4.
- Informed Consent and Compliance Ability to understand and comply with the study requirements and provide written informed consent.
Who cannot join
- Contraindications to TMS Presence of intracranial metallic implants or other foreign bodies, including but not limited to cochlear implants, cardiac pacemakers, or internal metallic/magnetic fragments.
- Contraindications to EEG and MRI EEG: Known allergy to conductive paste or other EEG-related contraindications. MRI: History of claustrophobia, presence of MRI-incompatible implants, or extensive tattoos.
- Concurrent Physical Therapies Currently receiving Transcranial Magnetic Stimulation (TMS) or other therapeutic physical modalities, such as Transcranial Direct Current Stimulation (tDCS).
- Unstable Medical Conditions Presence of unstable systemic diseases requiring urgent pharmacological or surgical intervention.
- Neurological and Psychiatric History Personal or family history of epilepsy; History of moderate-to-severe psychiatric or psychological disorders; Chronic insomnia or regular use of sedative-hypnotics; Current use of medications that significantly alter central nervous system excitability.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Ronghui Yu, +8613466379791, bdyyec@163.com
Luhua Wei, M.D.
About this study
Official title: Exploration of the Efficacy of Individualized Transcranial Magnetic Stimulation in the Treatment of Parkinsonian Disorders
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:
- Does individualized targeted rTMS alleviate symptoms of parkinsonian disorders?
- Which clinical manifestations of parkinsonian syndromes are responsive to individualized targeted rTMS, and to what degree?
Read more
Procedures:
- Preparation (Screening) Participants will undergo clinical assessments, MRI, and EEG before the treatment.
- Treatment (2 Weeks) Participants will receive a 10-day TMS treatment (once daily, Monday-Friday). Each treatment day takes approximately 3-4 hours. Participants need to keep stable medications and rehabilitation routines during this time.
- Follow-up (10 Weeks) Participants will undergo follow-up assessments at the end of treatment and 10 weeks after treatment. Assessments include clinical scales, MRI, and EEG.
Read the detailed description
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.
- Being tested
- TMS
- Keywords
- parkinsonian disorders, transcranial magnetic stimulation, somato-cognitive action network
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| individualized rTMS | Experimental | Not described Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to post-treatment and 10 weeks after treatment
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to post-treatment and 10 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start22 Dec 2025
- Primary completion22 Sep 2027 (estimated)
- Study completion22 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changping Laboratory
- Responsible party
- Sponsor
- Investigators
- Zhaoxia Wang, M.D., Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570212
- Sponsor's protocol ID
- PKUFH-2026-TMS-001
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy concerns and institutional regulations.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Efficacy of Individualized Transcranial Magnetic Stimulation in the Treatment of Parkinsonian Disorders
- ClinicalTrials.gov ID
- NCT07570212
- Acronym / sponsor ID
- PKUFH-2026-TMS-001
- Keywords
- parkinsonian disorders, transcranial magnetic stimulation, somato-cognitive action network
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Changping Laboratory
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 22 Sep 2027 (estimated)
- Study completion
- 22 Dec 2027 (estimated)
- First posted
- 6 May 2026 (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.
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:
- Does individualized targeted rTMS alleviate symptoms of parkinsonian disorders?
- Which clinical manifestations of parkinsonian syndromes are responsive to individualized targeted rTMS, and to what degree?
Procedures:
- Preparation (Screening) Participants will undergo clinical assessments, MRI, and EEG before the treatment.
- Treatment (2 Weeks) Participants will receive a 10-day TMS treatment (once daily, Monday-Friday). Each treatment day takes approximately 3-4 hours. Participants need to keep stable medications and rehabilitation routines during this time.
- Follow-up (10 Weeks) Participants will undergo follow-up assessments at the end of treatment and 10 weeks after treatment. Assessments include clinical scales, MRI, and EEG.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| individualized rTMS | Experimental | Device: TMS |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnostic Criteria Clinically established or clinically probable Parkinson's Disease (PD) according to the 2015 International Parkinson and Movement Disorder Society (MDS) diagnostic criteria; Clinically established or clinically probable Multiple System Atrophy (MSA) according to the 2022 MDS diagnostic criteria; Clinically probable or clinically possible Progressive Supranuclear Palsy (PSP) according to the 2017 MDS diagnostic criteria.
- Demographics Aged 30 to 80 years, inclusive; no gender restrictions.
- Disease Severity and Staging PD: Modified Hoehn and Yahr (H-Y) stage 2-4; MSA: Unified Multiple System Atrophy Rating Scale (UMSARS) Part IV stage 1-4; PSP: Modified Rankin Scale (mRS) grade 2-4.
- Informed Consent and Compliance Ability to understand and comply with the study requirements and provide written informed consent.
Key exclusion criteria (5 listed)
- Contraindications to TMS Presence of intracranial metallic implants or other foreign bodies, including but not limited to cochlear implants, cardiac pacemakers, or internal metallic/magnetic fragments.
- Contraindications to EEG and MRI EEG: Known allergy to conductive paste or other EEG-related contraindications. MRI: History of claustrophobia, presence of MRI-incompatible implants, or extensive tattoos.
- Concurrent Physical Therapies Currently receiving Transcranial Magnetic Stimulation (TMS) or other therapeutic physical modalities, such as Transcranial Direct Current Stimulation (tDCS).
- Unstable Medical Conditions Presence of unstable systemic diseases requiring urgent pharmacological or surgical intervention.
- Neurological and Psychiatric History Personal or family history of epilepsy; History of moderate-to-severe psychiatric or psychological disorders; Chronic insomnia or regular use of sedative-hypnotics; Current use of medications that significantly alter central nervous system excitability.
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 |
|---|---|---|
| TMSIntermittent 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. | Device | individualized rTMS |
Primary outcome
Change in motor symptoms measured by MDS-UPDRS Part III
Time frame: Baseline to post-treatment and 10 weeks after treatment
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.
Change in mobility measured by the 5-meter Timed Up and Go test
Time frame: Baseline to post-treatment and 10 weeks after treatment
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.
Change in non-motor symptoms measured by the Non-Motor Symptoms Questionnaire
Time frame: Baseline to post-treatment and 10 weeks after treatment
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.
7 secondary outcomes
Change in motor symptoms measured by UMSARS Part II
Time frame: Baseline to post-treatment and 10 weeks after treatment
Change in disease severity measured by PSPRS
Time frame: Baseline to post-treatment and 10 weeks after treatment
Change in balance measured by the Berg Balance Scale
Time frame: Baseline to post-treatment and 10 weeks after treatment
Change in ataxia severity measured by SARA
Time frame: Baseline to post-treatment and 10 weeks after treatment
Change in autonomic symptoms measured by the COMPASS-31
Time frame: Baseline to post-treatment and 10 weeks after treatment
Change in maximal systolic blood pressure drop during active standing
Time frame: Baseline to post-treatment and 10 weeks after treatment
Change in post-void residual volume
Time frame: Baseline to post-treatment and 10 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy concerns and institutional regulations.
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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.
Zhaoxia Wang, M.D. principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with Parkinson's Disease and Multiple System Atrophy, run by Peking University First Hospital 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: looking for participants now, as of the sponsor's last update on 29 Jun 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luhua Wei, M.D. (+8615120079081, weiluhua2008@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in motor symptoms measured by MDS-UPDRS Part III (time frame: Baseline to post-treatment and 10 weeks after treatment). 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?
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 29 Jun 2026.