An Open-label Study on the Clinical Efficacy of rTMS Intervention in PD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorAnhui Medical University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
transcranial magnetic stimulation
Other interventionDuring treatment, the patient underwent cTBS targeting the left SMA for 7 consecutive days. Each treatment day comprised six rounds of cTBS, with a 15-minute interval between each. A single cTBS session involved trains of three pulses at 50 Hz, repeated every 200 ms (5 Hz), until reaching a total of 600 pulses, lasting 40s. Stimulation intensity remained at 80% of resting motor threshold. In total, patients received 25,200 pulses throughout the treatment period.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: rTMS groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale Part Ⅲ
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.
Time frame
baseline; day 8; week 5;week 9;Secondary outcomes
1
Hoehn-Yahr(H-Y) stage
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.
Time frame
baseline; day 8; week 5;week 9;2
The timed up and go test
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.
Time frame
baseline; day 8; week 5;week 9;Sponsors and contacts
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Source ClinicalTrials.gov