The Effect of Multi-target Magnetic Stimulation on Freezing 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

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-12-30

Brief Summary

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This study is a double-blinded randomized study examining the effectiveness of the multi-target magnetic stimulation treatment on Freezing of Gait (FOG) phenomenon in patients with Parkinson's disease. We hypothesize that treatment using magnetic stimulation on motor cortex combined with spinal cord 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 active magnetic stimulation with low frequency repetitive transcranial magnetic stimulation (rTMS) over the bilateral primary motor cortex of the lower leg followed by low frequency repetitive magnetic stimulation over the spinal cord, whereas patients in the Active Comparator group underwent ten sessions of single active magnetic stimulation with low 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 and spinal cord. Assessments of FOG, gait function, motor symptoms and excitability of primary motor cortex motor were performed three times: at baseline, one day post intervention, one 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 active magnetic stimulation

the multi-target magnetic stimulation on motor cortex combined with spinal cord

Group Type EXPERIMENTAL

magnetic stimulation

Intervention Type DEVICE

For Experimental Arm, active magnetic stimulation on motor cortex followed by active magnetic stimulation on spinal cord, patients underwent ten sessions of double active magnetic stimulation with low frequency repetitive transcranial magnetic stimulation (rTMS) over the bilateral primary motor cortex of the lower leg followed by low frequency repetitive magnetic stimulation over the spinal cord. For Active Comparator Arm, active magnetic stimulation on motor cortex followed by sham magnetic stimulation on spinal cord. For Sham Comparator Arm, sham magnetic stimulation on motor cortex followed by sham magnetic stimulation on spinal cord.

single active magnetic stimulation

the active magnetic stimulation on motor cortex and sham stimulation on spinal cord

Group Type ACTIVE_COMPARATOR

magnetic stimulation

Intervention Type DEVICE

For Experimental Arm, active magnetic stimulation on motor cortex followed by active magnetic stimulation on spinal cord, patients underwent ten sessions of double active magnetic stimulation with low frequency repetitive transcranial magnetic stimulation (rTMS) over the bilateral primary motor cortex of the lower leg followed by low frequency repetitive magnetic stimulation over the spinal cord. For Active Comparator Arm, active magnetic stimulation on motor cortex followed by sham magnetic stimulation on spinal cord. For Sham Comparator Arm, sham magnetic stimulation on motor cortex followed by sham magnetic stimulation on spinal cord.

double sham magnetic stimulation

the sham magnetic stimulation on motor cortex and sham stimulation on spinal cord

Group Type SHAM_COMPARATOR

magnetic stimulation

Intervention Type DEVICE

For Experimental Arm, active magnetic stimulation on motor cortex followed by active magnetic stimulation on spinal cord, patients underwent ten sessions of double active magnetic stimulation with low frequency repetitive transcranial magnetic stimulation (rTMS) over the bilateral primary motor cortex of the lower leg followed by low frequency repetitive magnetic stimulation over the spinal cord. For Active Comparator Arm, active magnetic stimulation on motor cortex followed by sham magnetic stimulation on spinal cord. For Sham Comparator Arm, sham magnetic stimulation on motor cortex followed by sham magnetic stimulation on spinal cord.

Interventions

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magnetic stimulation

For Experimental Arm, active magnetic stimulation on motor cortex followed by active magnetic stimulation on spinal cord, patients underwent ten sessions of double active magnetic stimulation with low frequency repetitive transcranial magnetic stimulation (rTMS) over the bilateral primary motor cortex of the lower leg followed by low frequency repetitive magnetic stimulation over the spinal cord. For Active Comparator Arm, active magnetic stimulation on motor cortex followed by sham magnetic stimulation on spinal cord. For Sham Comparator Arm, sham magnetic stimulation on motor cortex followed by sham magnetic stimulation on spinal cord.

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 in both medication "on" and "off" states.

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, termor, 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