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

Anhui Medical University

Status: Enrolling

Conditions: Supplementary Motor Area; Parkinson Disease; Transcranial Magenetic Stimualtion

Treatments: Other: transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06383247

AMU-PD-multicenter

Details and patient eligibility

About

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.

Full description

This is a multi-center, double-blind, randomized controlled study that will be implemented in multiple hospital centers in China. In this study, the supplementary motor area (SMA) of the dominant hemisphere was selected as the stimulation target, and continuous theta burst stimulation (cTBS) sequence contact stimulation was used for a course of continuous stimulation for 7 days to observe the changes in clinical symptoms before and after the intervention.

Enrollment: 290 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Previously head MRI/CT was focal brain injury or severe leukoencephalopathy (Fazekas grade 3 and above);
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 has 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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290 participants in 2 patient groups, including a placebo group

Real rTMS group

Experimental group

Description:

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

Treatment:

Other: transcranial magnetic stimulation

Sham rTMS group

Placebo Comparator group

Description:

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

Treatment:

Other: transcranial magnetic stimulation