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

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

Recruiting
40 years and older
All
Phase N/A

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Overview

To demonstrate that intervention targeting the supplementary motor area (SMA) using precise navigation positioning can effectively improve motor symptoms in patients with Parkinson's disease.

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 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.

Eligibility

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.

Study details
    Transcranial Magnetic Stimulation
    Parkinson Disease
    Supplementary Motor Area

NCT06542991

Anhui Medical University

21 October 2025

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