The Efficacy of Repetitive Transcranial Magnetic Stimulation in Parkinson's Disease：A Randomized, Double-blind, Multicenter, Placebo-controlled Trial

NCT06583278 | Not Yet Recruiting DMC

• 1 other identifier: AHMU-PPD
• Study Type: interventional
• Target: 312
• Locations: 0 countries
• Sites: N/A

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 (14)

• 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

ACTIVE COMPARATOR

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

Device: transcranial magnetic stimulation

Sham rTMS group

SHAM COMPARATOR

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

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation DEVICE

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 Movement Disorder Society standards;
• Have no history of drug adjustment within 4 weeks before and during treatment;
• The MDS-UPDRS Ⅲ score ≥8, and the Hoehn-Yahr rating is 1-4
• MMSE ≥24，able to cooperate with the completion of behavioral tests and transcranial magnetic stimulation therapy.

You may not qualify if:

• Head MRI/CT ruled out focal brain injury or severe leukoencephalopathy (Fazekas grade 3);
• 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 or first-degree relatives have 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

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

Central Study Contacts

Panpan Hu, M.D.

CONTACT

13515602285; hpppanda9@126.com

Kai Wang, Ph.D.

CONTACT

055162923704; wangkai1964@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• 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: September 1, 2024
• First Posted: September 4, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share