The Efficacy and Safety of Precision REpetitive Transcranial Magnetic Stimulation in Alleviating Motor Symptom in Parkinson's Disease

NCT06383247 | Recruiting DMC

• 1 other identifier: AMU-PD-multicenter
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive and widely used neuromodulation technology. Small sample studies have shown that rTMS treatment can significantly improve the symptoms of Parkinson's disease(PD) and delay the progression of the disease. In order to further explore the effectiveness of rTMS in the treatment of PD and lay the foundation for its clinical promotion, our research team plans to conduct a randomized double-blind controlled study of rTMS in the treatment of PD in multiple centers across the country.

Conditions

Parkinson Disease; Transcranial Magenetic Stimualtion; Supplementary Motor Area

Keywords

Parkinson Disease; transcranial magenetic stimualtion; supplementary motor area

Outcome Measures

Primary Outcomes (1)

• Movement Disorder Society- Unified Parkinson's Disease Rating Scale III scores

  This is an very common clinical motor estimating scale with 18 items and 140' in total. Higher scores indicate worse symptoms.

  baseline; day 8; week 5;week 9

Secondary Outcomes (13)

• Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅰ scores

  baseline; day 8; week 5;week 9

• Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅱ scores

  baseline; day 8; week 5;week 9

• Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅳ scores

  baseline; day 8; week 5;week 9

• Hoehn-Yahr(H-Y) scale

  baseline; day 8; week 5;week 9

• The timed up and go test (TUG)

  baseline; day 8; week 5;week 9

Study Arms (2)

Real rTMS group

EXPERIMENTAL

Participants will receive active transcranial magnetic stimulation (TMS) daily for 1 week.

Other: transcranial magnetic stimulation

Sham rTMS group

PLACEBO COMPARATOR

Participants will receive sham transcranial magnetic stimulation (TMS) daily for 1 week

Other: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation OTHER

The stimulations were performed by MagStim Rapid2.

Real rTMS group; Sham rTMS group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40 years old;
• Meet the diagnostic criteria for idiopathic Parkinson's disease (MDS Diagnostic Criteria for Parkinson's Disease (2015 Edition))\[1\];
• Have no history of drug adjustment within 4 weeks before treatment and the entire study period;
• The MDS-UPDRS Ⅲ score ≥8, and the Hoehn-Yahr rating is 1-4;
• MMSE ≥22，able to cooperate with the completion of behavioral tests and transcranial magnetic stimulation therapy.

You may not qualify if:

• Previously head MRI/CT was focal brain injury or severe leukoencephalopathy (Fazekas grade 3 and above);
• Various secondary parkinsonism syndromes (vascular parkinsonism, Parkinsonism combined with parkinsonism, drug parkinsonism, etc.);
• Severe craniocerebral trauma, received craniocerebral surgery or deep brain stimulation treatment;
• There are ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.
• The person has a history of epilepsy, unexplained loss of consciousness, or are taking anticonvulsant drugs to treat epileptic seizures;
• Diagnosed with a neuropsychiatric disorder other than PD
• Have a history of drug abuse or drug use;
• Participants in any clinical trial within the previous 6 month;
• Pregnant/lactating women or subjects (including men) who have a birth plan within 6 months;

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Cognitive Neuropsychology Lab Anhui Medical University

Hefei, Anhui, 230032, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Panpan Hu, M.D.

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panpan Hu, M.D.

CONTACT

+8613515602285; hpppanda9@126.com

Kai Wang, Ph.D.

CONTACT

+8655162923704; wangkai1964@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: December 6, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)