A Randomized Sham-Controlled Trial of High-frequency RTMS in the Treatment of Upper Limb Bradykinesia in Patients with Parkinson's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson's Disease (PD)
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
Brief Summary
A randomized, double-blind, sham-controlled unicenter clinical trial was used to investigate the effectiveness and neural mechanism of high-frequency repetitive transcranial magnetic stimulation in the treatment of upper limb bradykinesia in patients with Parkinson's disease.
Investigators
Zhengguo Liu
Director of Department of Neurology, Principal Investigator, Clinical Professor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Hoehn and Yahr (HY) stage 1-2
- •Able to understand and cooperate with the study
- •Predominantly characterized by bradykinesia
- •Onset on the left side
Exclusion Criteria
- •Contraindications for TMS including DBS surgery, Ventriculoperitoneal shunt, etc
- •Other neurological disorders
- •Significant resting tremor, with MDS-UPDRS-III tremor score ≥3
- •Resting threshold cannot be measured
- •Received other TMS treatments within the last 3 months
Outcomes
Primary Outcomes
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time Frame: 2 weeks and 4 weeks
Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III from Day 1 to 1 year. The part III of the MDS-UPDRS assess motor function in best on phase. The score range is 0-132, where a higher score means more severe motor impairment.
Secondary Outcomes
- cortical activation detected by fNIRS(2 weeks and 4 weeks)