Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease
- Conditions
- Transcranial Magnetic StimulationParkinson's Disease
- Interventions
- Drug: Pharmacotherapy（antiparkinsonian drugs）Other: transcranial magnetic stimulation
- Registration Number
- NCT06365190
- Lead Sponsor
- Anhui Medical University
- Brief Summary
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.
- Detailed Description
This was a open-label clinical trial to assess the Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease.
Participants were randomly assigned to the cTBS group and the control group on a 1:1 basis using age as a stratification factor. In the cTBS group, after baseline assessment, participants received cTBS treatment on the left supplementary motor area(SMA) for 14 days, and symptoms were assessed on the second day after treatment. Ten weeks after completion of assessment, a second cTBS session was performed, with all patients taking stable doses of antiparkinsonian medications. The control group only received drug intervention, and symptom assessment was conducted at weeks 13, 23 , 33 , and 43. To rule out the influence of medication on symptom assessment, all patients stopped taking medication for at least 12 hours before assessment.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 47
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drug group Pharmacotherapy（antiparkinsonian drugs） Take antiparkinsonian medications regularly, with follow-up every 8 weeks including medication guidance and symptom assessment cTBS group transcranial magnetic stimulation On the basis of drug treatment, a course of TBS treatment is performed every eight weeks.
- Primary Outcome Measures
Name Time Method Unified Parkinson's Disease Rating Scale III scores baseline; week 3; week 13;week 23;week 33 This is an very common clinical motor estimating scale with 14 items and 108' in total. Higher scores indicate worse symptoms.
- Secondary Outcome Measures
Name Time Method Levodopa equivalent dose baseline; week 3; week 13;week 23;week 33 Different antiparkinsonian drugs converted to equivalent amounts of levodopa.
Hoehn-Yahr(H-Y) stage baseline; week 3; week 13;week 23;week 33 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.
Trial Locations
- Locations (1)
Cognitive Neuropsychology Lab Anhui Medical University
🇨🇳Hefei, Anhui, China