Individualized Transcranial Magnetic Stimulation in Parkinsonian Disorders

NCT07570212 | Recruiting

• 1 other identifier: PKUFH-2026-TMS-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson's Disease; Multiple System Atrophy; Progressive Supranuclear Palsy

Keywords

parkinsonian disorders; transcranial magnetic stimulation; somato-cognitive action network

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Change in motor symptoms measured by UMSARS Part II

  Baseline to post-treatment and 10 weeks after treatment

• Change in disease severity measured by PSPRS

  Baseline to post-treatment and 10 weeks after treatment

• Change in balance measured by the Berg Balance Scale

  Baseline to post-treatment and 10 weeks after treatment

• Change in ataxia severity measured by SARA

  Baseline to post-treatment and 10 weeks after treatment

• Change in autonomic symptoms measured by the COMPASS-31

  Baseline to post-treatment and 10 weeks after treatment

Study Arms (1)

individualized rTMS

EXPERIMENTAL

Device: TMS

Interventions

TMS DEVICE

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.

individualized rTMS

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Changping Laboratory: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy; Supranuclear Palsy, Progressive; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhaoxia Wang, M.D.

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luhua Wei, M.D.

CONTACT

+8615120079081; weiluhua2008@outlook.com

Kai Li, M.D.

CONTACT

+8613511017809; kaili_neurologist@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 6, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): September 22, 2027
• Study Completion (Estimated): December 22, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)