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Clinical Trials/NCT06365190
NCT06365190
Active, not recruiting
Not Applicable

Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease

Anhui Medical University1 site in 1 country47 target enrollmentApril 6, 2020

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.

Registry
clinicaltrials.gov
Start Date
April 6, 2020
End Date
July 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Anhui Medical University
Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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