Clinical trial NCT06365190: Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease
Official title: Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Parkinson's Disease
Keywords: Transcranial Magnetic Stimulation
Parkinson's Disease
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 47
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale III scores
timeFrame: baseline; week 3; week 13;week 23;week 33
Secondary outcomes:
measure: Hoehn-Yahr(H-Y) stage
timeFrame: baseline; week 3; week 13;week 23;week 33
measure: Levodopa equivalent dose
timeFrame: baseline; week 3; week 13;week 23;week 33
Other outcomes:
Locations:
city: Hefei
country: China
facility: Cognitive Neuropsychology Lab Anhui Medical University
state: Anhui
Study officials:
References: