Clinical trial NCT06583278: The Efficacy of Repetitive Transcranial Magnetic Stimulation in Parkinson&#39;s Disease：A Randomized, Double-blind, Multicenter, Placebo-controlled Trial
Official title: The Efficacy of Repetitive Transcranial Magnetic Stimulation in Parkinson&#39;s Disease：A Randomized, Double-blind, Multicenter, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Transcranial Magenetic Stimualtion
Supplementary Motor Area
Keywords: Parkinson Disease
Transcranial Magenetic Stimualtion
Supplementary Motor Area
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 312
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale III scores
timeFrame: baseline; day 8; week 5;week 9
Secondary outcomes:
measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale I scores
timeFrame: baseline; day 8; week 5;week 9
measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅱ scores
timeFrame: baseline; day 8; week 5;week 9
measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅳ scores
timeFrame: baseline; day 8; week 5;week 9
measure: Hoehn-Yahr(H-Y) scale
timeFrame: baseline; day 8; week 5;week 9
measure: The timed up and go test (TUG)
timeFrame: baseline; day 8; week 5;week 9
measure: 20 meters walking
timeFrame: baseline; day 8; week 5;week 9
measure: Upper and lower limb rotation counting
timeFrame: baseline; day 8; week 5;week 9
measure: Non-motor symptom scale（NMSS）
timeFrame: baseline; day 8; week 5;week 9
measure: Clinical Global Impression（CGI）
timeFrame: baseline; day 8; week 5;week 9
measure: Parkinson's Disease questionnaire-39 items（PDQ-39）
timeFrame: baseline; day 8; week 5;week 9
measure: Hamilton Depression Scale-17（HAMD-17）
timeFrame: baseline; day 8; week 5;week 9
measure: Hamilton Anxiety Scale（HAMA）
timeFrame: baseline; day 8; week 5;week 9
measure: Pittsburgh sleep quality index（PSQI）
timeFrame: baseline; day 8; week 5;week 9
measure: Montreal Cognitive Assessment（MoCA）
timeFrame: baseline; day 8; week 5;week 9
Other outcomes:
Locations:
Study officials:
References: