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

NCT ID: NCT06641193

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-27

Study Completion Date

2025-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease (PD) Bradykinesia Upper Limb Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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verum group

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

Group Type EXPERIMENTAL

high frequency-repetitive transcranial magnetic stimulation

Intervention Type 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 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.

Group Type SHAM_COMPARATOR

sham stimulation

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Zhengguo Liu

Director of Department of Neurology, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China, China

Site Status

Countries

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China

Other Identifiers

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XHEC-C-2024-125-2-2

Identifier Type: -

Identifier Source: org_study_id

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