Clinical Trail of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Upper Limb Bradykinesia in Parkinson' Disease' Patients

Not Applicable

• Conditions: Parkinson's Disease (PD); Bradykinesia; Upper Limb Function

• Registration Number: NCT06641193
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-27
• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-11
• Study First Posted: 2024-10-15
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31
• Primary Completion: 2025-07-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	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 Outcome Measures

Name	Time	Method
cortical activation detected by fNIRS	2 weeks and 4 weeks	Using near-infrared brain imaging systems, have patients perform finger tapping, fist clenching, and forearm rotation movements to observe brain region activation.

Trial Locations

Locations (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China