Clinical trial
Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease
Name
AHMU-PD-rTMS
Description
Previous studies have shown that repetitive transcranial magnetic stimulation(rTMS) can improve clinical symptoms of Parkinson's disease(PD). Continuous theta-burst stimulation(cTBS) is a novel rTMS protocol that produces physiological effects b acting on neurons in the brain, which can decrease the excitability of motor system. This study aims to explore the long-term effects of cTBS on improvement of movement symptoms in patients with PD.
Trial arms
Trial start
2020-04-06
Estimated PCD
2024-07-31
Trial end
2024-07-31
Status
Active (not recruiting)
Treatment
transcranial magnetic stimulation
During treatment, the patient underwent cTBS targeting the left SMA for 14 consecutive days. Each treatment day comprised three 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.
Arms:
cTBS group
Pharmacotherapy（antiparkinsonian drugs）
Anti-Parkinson's disease drugs include compound levodopa, dopamine receptor agonists, monoamine oxidase type B inhibitors, catechol-O-methyl transferase inhibitors, etc. Take dopaminergic agents regularly, with follow-up every 8 weeks including medication guidance and symptom assessment
Arms:
Drug group
Size
47
Primary endpoint
Unified Parkinson's Disease Rating Scale III scores
baseline; week 3; week 13;week 23;week 33
Eligibility criteria
Inclusion Criteria:
* Meet the Chinese diagnostic criteria for Parkinson's disease (2016 version);
* Age ≥ 40 years old;
* Stable use of medication for at least 2 weeks;
* MMSE score ≧ 24 points;
* Those who can cooperate to complete the experiment; (6) Those who have not received rTMS treatment in the past.
Exclusion Criteria:
* History or clinical symptoms of other serious mental illnesses (such as major depression, psychosis, or obsessive-compulsive disorder);
* Severe organic brain defects on T1 or T2 images;
* History or unknown epilepsy Cause of loss of consciousness;
* Head injury, stroke or other neurological disease;
* Immovable metal objects on or around the head;
* History of drug abuse within the past 6 months.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 47, 'type': 'ACTUAL'}}
Updated at
2024-04-16
1 organization
Organization
Anhui Medical University