Actively Recruiting
An Open-label Study on the Clinical Efficacy of rTMS Intervention in Parkinson's Disease
Led by Anhui Medical University · Updated on 2024-08-07
20
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, to improve motor symptoms in patients with Parkinson's disease. This study focuses on targeting the supplementary motor area (SMA), a brain region linked to motor function, using precise neuroimaging navigation. The goal is to assess the clinical effects of this targeted rTMS intervention in patients with idiopathic Parkinson's disease. Participants will be randomly assigned to receive either real or sham stimulation. The treatment involves continuous theta burst stimulation (cTBS) applied to the left SMA for 7 consecutive days. Each day includes six cTBS sessions, separated by 15-minute intervals, with each session lasting 40 seconds and delivering a total of 600 pulses at 80% of the resting motor threshold. The intervention is given alongside participants' usual drug treatments. During the study, participants will be evaluated using the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III to measure motor symptom changes at baseline, day 8, week 5, and week 9. Additional assessments include the Hoehn-Yahr staging and the timed up and go test at the same time points. Safety and symptom monitoring will continue throughout the study, which is expected to last until March 2025.
CONDITIONS
Brief Title
An Open-label Study on the Clinical Efficacy of rTMS Intervention in PD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older
- Diagnosis meets Movement Disorder Society standards
- No changes in Parkinson's medication within 4 weeks before and during treatment
- MDS-UPDRS Part III score of 8 or higher and Hoehn-Yahr stage between 1 and 4
- MMSE score of 24 or higher and able to cooperate with behavioral tests and therapy
You will not qualify if you...
- MRI or CT shows focal brain injury or severe leukoencephalopathy (Fazekas grade 3)
- Secondary parkinsonism syndromes such as vascular or drug-induced parkinsonism
- Severe brain trauma, brain surgery, or prior deep brain stimulation treatment
- Presence of ferromagnetic implants like cochlear implants or cardiac pacemakers
- Personal or first-degree relative history of epilepsy, unexplained loss of consciousness, or current use of anticonvulsants
- Diagnosed neuropsychiatric disorders other than Parkinson's disease
- History of drug abuse or drug use
- Participation in any clinical trial within the previous 6 months
- Pregnant or lactating women, or planning pregnancy within 6 months
- Other conditions considered unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days
Participants receive repetitive transcranial magnetic stimulation (rTMS) targeting the left supplementary motor area (SMA) for 7 consecutive days with six sessions each day.
7 daily visits (in-person)
Duration - Up to 9 weeks
Participants are monitored for changes in motor symptoms and clinical status after treatment ends.
Visits at Day 8, Week 5, and Week 9
Trial Site Locations
Total: 1 location
1
Cognitive Neuropsychology Lab Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
Research Team
K
Kai Wang, Ph.D.
P
Panpan Hu, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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