The Efficacy of Repetitive Transcranial Magnetic Stimulation in Parkinson's Disease：A Randomized, Double-blind, Multicenter, Placebo-controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcranial magnetic stimulation.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Transcranial Magenetic Stimualtion, Supplementary Motor Area. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device transcranial magnetic stimulation
The stimulations were performed by MagStim Rapid2.
Primary outcome measures
- Movement Disorder Society- Unified Parkinson's Disease Rating Scale III scores [Time frame: baseline; day 8; week 5;week 9]
Secondary outcome measures (12)
- Movement Disorder Society- Unified Parkinson's Disease Rating Scale I scores [Time frame: baseline; day 8; week 5;week 9]
- Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅱ scores [Time frame: baseline; day 8; week 5;week 9]
- Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅳ scores [Time frame: baseline; day 8; week 5;week 9]
- Hoehn-Yahr(H-Y) scale [Time frame: baseline; day 8; week 5;week 9]
- The timed up and go test (TUG) [Time frame: baseline; day 8; week 5;week 9]
- 20 meters walking [Time frame: baseline; day 8; week 5;week 9]
- Upper and lower limb rotation counting [Time frame: baseline; day 8; week 5;week 9]
- Non-motor symptom scale（NMSS） [Time frame: baseline; day 8; week 5;week 9]
- Clinical Global Impression（CGI） [Time frame: baseline; day 8; week 5;week 9]
- Parkinson's Disease questionnaire-39 items（PDQ-39） [Time frame: baseline; day 8; week 5;week 9]
- Hamilton Depression Scale-17（HAMD-17） [Time frame: baseline; day 8; week 5;week 9]
- Hamilton Anxiety Scale（HAMA） [Time frame: baseline; day 8; week 5;week 9]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- Other conditions deemed unsuitable for inclusion by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06583278 · AHMU-PPD