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Enrolling by invitationNCT06641193Updated Oct 31, 2024

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

An interventional study of high frequency-repetitive transcranial magnetic stimulation and sham stimulation in Parkinson's Disease (PD), Bradykinesia and Upper Limb Function, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Enrolling by invitation at 1 site in China. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-31.

Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Browse trials for

03

In context

Hypokinesia

33 studies on the registry are indexed under Hypokinesia; 8 are open to participants now.

This study's planned enrollment of 60 is above the median of 31 across 20 interventional studies indexed under Hypokinesia.

Browse Hypokinesia studies →

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 225 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Devicehigh 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.

  • Devicesham 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.

06

What researchers measure

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.

    Time frame: 2 weeks and 4 weeks

Secondary outcomes

  1. 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.

    Time frame: 2 weeks and 4 weeks

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2024 (actual). Primary completion is estimated for Jul 2025, 10 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2024
First posted
Oct 15, 2024
StartActual
Aug 27, 2024
Primary completionEst.
Jul 1, 2025
CompletionEst.
Aug 1, 2025
Last update
Oct 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06641193
Responsible party
Zhengguo Liu (Director of Department of Neurology, Principal Investigator, Clinical Professor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Oct 15, 2024
Start date
Aug 27, 2024
Primary completion
Jul 1, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
Oct 31, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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