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

Not Applicable

Recruiting

• Conditions: Supplementary Motor Area; Transcranial Magnetic Stimulation; Parkinson Disease
• Interventions: Other: transcranial magnetic stimulation

• Registration Number: NCT06542991
• Lead Sponsor: Anhui Medical University

Brief 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.

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 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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-03
• Study First Submitted QC: 2024-08-03
• Last Update Submitted: 2024-08-03
• Study First Posted: 2024-08-07
• Last Update Posted: 2024-08-07
• Study Start: 2024-09-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rTMS group	transcranial magnetic stimulation	On the basis of drug treatment, a course of TBS treatment is performed for 7 days.

Primary Outcome Measures

Name	Time	Method
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale Part Ⅲ	baseline; day 8; week 5;week 9;	The primary outcome was the change in MDS-UPDRS III from baseline to 9 weeks of follow-up. MDS-UPDRS III is a questionnaire used by uniformly trained professionals to evaluate motor symptoms in patients with Parkinson's disease\[21\]. The questionnaire consists of 18 items, which professionals need to score according to the patient's motor symptoms, on a scale of 0-4. Among them, items 3.3-3.8 and 3.15-3.17 can be divided into several sub-items according to the body parts. The results of MDS-UPDRS III are the total of 18 items.

Secondary Outcome Measures

Name	Time	Method
Hoehn-Yahr(H-Y) stage	baseline; day 8; week 5;week 9;	It ranges from 1 to 5, and is evaluated based on the range of symptoms involved and whether balance is impaired in PD patients. The higher the score, the more severe the severity.
The timed up and go test	baseline; day 8; week 5;week 9;	TUG measures in seconds how long it takes the subject to rise from the chair, walk 3 meters, turn around, walk back to the chair, and sit down. The test is often used to assess walking and balance in older adults. This also applies to evaluating the severity of walking and balance symptoms in patients with Parkinson's disease.

Trial Locations

Locations (1)

Cognitive Neuropsychology Lab Anhui Medical University; 🇨🇳 Hefei, Anhui, China