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

N/AEnrolling By InvitationNCT06641193

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson's Disease (PD)Bradykinesia Upper Limb Function

Interventions

rTMS involves the repeated application of magnetic pulses to specific areas of the brain. These pulses are delivered using a coil placed on the scalp, which generates a magnetic field that induces electrical currents in the brain tissue.

sham stimulationDEVICE

The sham group receives 10 sessions of rTMS stimulation with a sham stimulation coil, which emits the same sound and vibration as the active coil but does not produce any induced electrical currents.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

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.

Time frame: 2 weeks and 4 weeks

Secondary Outcomes

cortical activation detected by fNIRS

Using near-infrared brain imaging systems, have patients perform finger tapping, fist clenching, and forearm rotation movements to observe brain region activation.