Clinical trial NCT06542991: An Open-label Study on the Clinical Efficacy of rTMS Intervention in PD
Official title: An Open-label Study on the Clinical Efficacy of rTMS Intervention in PD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Parkinson Disease
Supplementary Motor Area
Keywords: Transcranial Magnetic Stimulation
Parkinson Disease
Supplementary motor area
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale Part Ⅲ
timeFrame: baseline; day 8; week 5;week 9;
Secondary outcomes:
measure: Hoehn-Yahr(H-Y) stage
timeFrame: baseline; day 8; week 5;week 9;
measure: The timed up and go test
timeFrame: baseline; day 8; week 5;week 9;
Other outcomes:
Locations:
city: Hefei
country: China
facility: Cognitive Neuropsychology Lab Anhui Medical University
state: Anhui
Study officials:
References: