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Enrolling by invitation NCT06641193

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

No phase Interventional Parkinson's Disease (PD) Bradykinesia Upper Limb Function

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: high frequency-repetitive transcranial magnetic stimulation, sham stimulation.
Who it may be relevant to
Registry conditions: Parkinson's Disease (PD), Bradykinesia, Upper Limb Function. Basic parameters: 50 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Time frame: 2 weeks and 4 weeks]
Secondary outcome measures (1)
  • cortical activation detected by fNIRS [Time frame: 2 weeks and 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT06641193 · XHEC-C-2024-125-2-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗