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

NCT ID: NCT06583278

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2027-06-30

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.

Detailed Description

As an innovative non-invasive neuromodulation technology, repetitive transcranial magnetic stimulation (rTMS) has demonstrated efficacy in improving motor symptoms in patients with Parkinson's disease (PD). The supplementary motor area (SMA) has been identified as a brain region significantly associated with motor symptoms in PD patients. However, no large-sample clinical studies have yet established the clinical efficacy of rTMS, guided by neuroimaging navigation, targeting the SMA in patients with Parkinson's disease.

We describe a randomized, controlled, double-blind, placebo-treated, multicenter study designed to recruit 312 patients with idiopathic Parkinson's disease. Participants will be randomly assigned to receive either real stimulation or sham stimulation, with the left SMA undergoing 7 days of continuous theta burst stimulation (cTBS). The primary outcome measure is the change in the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scores from baseline to post-treatment and follow-up. Secondary outcomes include changes in scores on other clinical symptom scales. The study is expected to be conducted across nine medical centers in China, commencing in 2024 and concluding in 2026.

This study will evaluate the clinical efficacy of cTBS targeting the left SMA in patients with Parkinson's disease. The findings may offer a new therapeutic approach for PD.

Conditions

Parkinson Disease; Transcranial Magenetic Stimualtion; Supplementary Motor Area

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Real rTMS group

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

Group Type: ACTIVE_COMPARATOR

transcranial magnetic stimulation

Intervention Type: DEVICE

The stimulations were performed by MagStim Rapid2.

Sham rTMS group

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

Group Type: SHAM_COMPARATOR

transcranial magnetic stimulation

Intervention Type: DEVICE

The stimulations were performed by MagStim Rapid2.

Interventions

transcranial magnetic stimulation

The stimulations were performed by MagStim Rapid2.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥40 years old

2. Meet Movement Disorder Society standards;

3. Have no history of drug adjustment within 4 weeks before and during treatment;

4. The MDS-UPDRS Ⅲ score ≥8, and the Hoehn-Yahr rating is 1-4

5. MMSE ≥24，able to cooperate with the completion of behavioral tests and transcranial magnetic stimulation therapy.

Exclusion Criteria

1. Head MRI/CT ruled out focal brain injury or severe leukoencephalopathy (Fazekas grade 3);

2. Various secondary parkinsonism syndromes (vascular parkinsonism, Parkinsonism combined with parkinsonism, drug parkinsonism, etc.);

3. Severe craniocerebral trauma, received craniocerebral surgery or deep brain stimulation treatment;

4. There are ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.

5. The person or first-degree relatives have a history of epilepsy, unexplained loss of consciousness, or are taking anticonvulsant drugs to treat epileptic seizures;

6. Diagnosed with a neuropsychiatric disorder other than PD

7. Have a history of drug abuse or drug use;

8. Participants in any clinical trial within the previous 6 month;

9. Pregnant/lactating women or subjects (including men) who have a birth plan within 6 months;

10. Other conditions deemed unsuitable for inclusion by the investigator.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

WANG KAI

Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Panpan Hu, M.D.

Role: CONTACT

hpppanda9@126.com

13515602285

Kai Wang, Ph.D.

Role: CONTACT

wangkai1964@126.com

055162923704

Other Identifiers

AHMU-PPD

Identifier Type: -

Identifier Source: org_study_id