Individualized Transcranial Magnetic Stimulation in Parkinsonian Disorders

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?

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson's Disease; Multiple System Atrophy; Progressive Supranuclear Palsy
• Intervention / Treatment: Device: TMS

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luhua Wei, M.D.; Phone Number: +8615120079081; Email: weiluhua2008@outlook.com
• Study Contact Backup: Name: Kai Li, M.D.; Phone Number: +8613511017809; Email: kaili_neurologist@hotmail.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Ronghui Yu; Phone Number: +8613466379791; Email: bdyyec@163.com
      • Sub-Investigator: Luhua Wei, M.D.
      • Principal Investigator: Zhaoxia Wang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Demographics Aged 30 to 80 years, inclusive; no gender restrictions.
3. 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.
4. Informed Consent and Compliance Ability to understand and comply with the study requirements and provide written informed consent.

Exclusion Criteria:

1. 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.
2. 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.
3. Concurrent Physical Therapies Currently receiving Transcranial Magnetic Stimulation (TMS) or other therapeutic physical modalities, such as Transcranial Direct Current Stimulation (tDCS).
4. Unstable Medical Conditions Presence of unstable systemic diseases requiring urgent pharmacological or surgical intervention.
5. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: individualized rTMS

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline to post-treatment and 10 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	Baseline to post-treatment and 10 weeks after treatment

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: Changping Laboratory
• Investigators: Principal Investigator: Zhaoxia Wang, M.D., Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2025
• Primary Completion (Estimated): September 22, 2027
• Study Completion (Estimated): December 22, 2027

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: transcranial magnetic stimulation; parkinsonian disorders; somato-cognitive action network
• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Tauopathies; Neurodegenerative Diseases; Movement Disorders; Basal Ganglia Diseases; Cranial Nerve Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Ophthalmoplegia; Ocular Motility Disorders; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Parkinson Disease; Multiple System Atrophy; Supranuclear Palsy, Progressive; Parkinsonian Disorders
• Other Study ID Numbers: PKUFH-2026-TMS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to privacy concerns and institutional regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No