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

NCT06641193 | Enrolling By Invitation

• 1 other identifier: XHEC-C-2024-125-2-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks and 4 weeks

Secondary Outcomes (1)

• cortical activation detected by fNIRS

  2 weeks and 4 weeks

Study Arms (2)

verum group

EXPERIMENTAL

verum group receive real 10 sessions of rTMS stimulation. once daily for 5 consecutive days a week.

Device: high frequency-repetitive transcranial magnetic stimulation

sham group

SHAM COMPARATOR

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.

Device: sham stimulation

Interventions

high frequency-repetitive transcranial magnetic stimulation DEVICE

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.

verum group

sham stimulation DEVICE

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.

sham group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hoehn and Yahr (HY) stage 1-2
• Able to understand and cooperate with the study
• Predominantly characterized by bradykinesia
• Onset on the left side

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China, 200092, China

Location

MeSH Terms

Conditions

Hypokinesia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Neurology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: August 27, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-08

Locations

CN (1)