A Randomized Sham-Controlled Trial of High-frequency RTMS in the Treatment of Upper Limb Bradykinesia in Patients with Parkinson's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
verum group
verum group receive real 10 sessions of rTMS stimulation. once daily for 5 consecutive days a week.
Intervention: high frequency-repetitive transcranial magnetic stimulation (Device)
sham group
The sham group receives 10 sessions of rTMS stimulation, once daily for 5 consecutive days a week. However, a sham stimulation coil is used, which emits the same sound and vibration as the active coil but does not produce any induced electrical currents.
Intervention: sham stimulation (Device)
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)
Investigators
Zhengguo Liu
Director of Department of Neurology, Principal Investigator, Clinical Professor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine