The Effect of Dual-site Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in PD

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-09-01

Brief Summary

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This study is a double-blinded randomized study examining the effectiveness of the dual-site repetitive transcranial magnetic stimulation on Freezing of Gait (FOG) in patients with Parkinson's disease. The investigators hypothesize that treatment using magnetic stimulation on double site (including M1-LL and SMA) will improve FOG and gait symptoms in patients with Parkinson's disease.

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Detailed Description

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Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex of the lower leg and supplementary motor area, whereas patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on motor cortex. Assessments of FOG, gait function, motor symptoms, excitability of cortex motor (using transcranial magnetic stimulation), plasma indicators and multimodal magnetic resonance were performed three times: at baseline, one day post intervention, one month post intervention, six month post intervention.

Conditions

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Parkinson Disease

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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double-site high frequency rTMS over the bilateral M1 of the lower leg and SMA

Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral M1 of the lower leg and SMA.

Group Type EXPERIMENTAL

magnetic stimulation

Intervention Type DEVICE

Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex of the lower leg and supplementary motor area, whereas patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on motor cortex.

single-site high frequency rTMS over the bilateral primary motor cortex of the lower leg

Patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral M1 of the lower leg.

Group Type ACTIVE_COMPARATOR

magnetic stimulation

Intervention Type DEVICE

Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex of the lower leg and supplementary motor area, whereas patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on motor cortex.

sham magnetic stimulation on motor cortex

Patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on M1.

Group Type SHAM_COMPARATOR

magnetic stimulation

Intervention Type DEVICE

Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex of the lower leg and supplementary motor area, whereas patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on motor cortex.

Interventions

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magnetic stimulation

Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex of the lower leg and supplementary motor area, whereas patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on motor cortex.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
2. Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1.
3. Age between 40 and 80 years old.
4. Mini-Mental State Examination score \>24.
5. Ability to walk 30 meters independently.
6. Stable medication.
7. Patients experienced FOG during an interview.

Exclusion Criteria

1. Other neurological or psychiatric disorders.
2. Severe personality disorder. History of epilepsy, seizures, or convulsions.
3. History of head injury or stroke.
4. Metal remains of the skull or inside the brain (outside the oral cavity).
5. Surgeries including metallic implants or known history of metal particles in the eye, pacemakers,hearing devices transplantation, or medical pumps.
6. Severe dyskinesia, tremor, cognitive, visual or auditory impairment.
7. Patients who could not complete the follow-up.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes