Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06641193

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Parkinson's Disease (PD) Bradykinesia Dyskinesias Hypokinesia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Upper Limb Function

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China, 200092

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Shanghai Jiao Tong University School of Medicine

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.