An Open-label Study on the Clinical Efficacy of rTMS Intervention in PD

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 open-lable study designed to recruit 20 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.

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.