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

October 29, 2024 updated by: Zhengguo Liu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

A Randomized Sham-Controlled Trial of High-frequency RTMS in the Treatment of Upper Limb Bradykinesia in Patients with Parkinson's Disease

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200092
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: verum group
verum group receive real 10 sessions of rTMS stimulation. once daily for 5 consecutive days a week.
Device: high frequency-repetitive transcranial magnetic stimulation
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 Comparator: 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.
Device: sham stimulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cortical activation detected by fNIRS
Time Frame: 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.
2 weeks and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 29, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XHEC-C-2024-125-2-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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