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

Last updated: August 3, 2024
Sponsor: Anhui Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

transcranial magnetic stimulation

Clinical Study ID

NCT06542991
PD-OPEN
  • Ages > 40
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 transcranialmagnetic stimulation therapy.

Exclusion

Exclusion Criteria:

  1. Head MRI/CT ruled out focal brain injury or severe leukoencephalopathy (Fazekasgrade 3);

  2. Various secondary parkinsonism syndromes (vascular parkinsonism, Parkinsonismcombined with parkinsonism, drug parkinsonism, etc.);

  3. Severe craniocerebral trauma, received craniocerebral surgery or deep brainstimulation treatment;

  4. There are ferromagnetic implants in the body, such as cochlear implants, cardiacpacemakers, etc.

  5. The person or first-degree relatives have a history of epilepsy, unexplained loss ofconsciousness, 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 6months;

  10. Other conditions deemed unsuitable for inclusion by the investigator.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: transcranial magnetic stimulation
Phase:
Study Start date:
September 01, 2024
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • Cognitive Neuropsychology Lab Anhui Medical University

    Hefei, Anhui
    China

    Active - Recruiting

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