Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease
Overview
- Phase
- Not Applicable
- Intervention
- transcranial magnetic stimulation
- Conditions
- Transcranial Magnetic Stimulation
- Sponsor
- Anhui Medical University
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Unified Parkinson's Disease Rating Scale III scores
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
WANG KAI
Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC
Anhui Medical University
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.
Arms & Interventions
cTBS group
On the basis of drug treatment, a course of TBS treatment is performed every eight weeks.
Intervention: transcranial magnetic stimulation
Drug group
Take antiparkinsonian medications regularly, with follow-up every 8 weeks including medication guidance and symptom assessment
Intervention: Pharmacotherapy(antiparkinsonian drugs)
Outcomes
Primary Outcomes
Unified Parkinson's Disease Rating Scale III scores
Time Frame: 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 Outcomes
- Levodopa equivalent dose(baseline; week 3; week 13;week 23;week 33)
- Hoehn-Yahr(H-Y) stage(baseline; week 3; week 13;week 23;week 33)