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

Nanjing Medical University

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05925296

2022-SRFA-020

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 53 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 3 patient groups

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

Experimental group

Description:

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

Treatment:

Device: magnetic stimulation

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

Active Comparator group

Description:

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.

Treatment:

Device: magnetic stimulation

sham magnetic stimulation on motor cortex

Sham Comparator group

Description:

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

Treatment:

Device: magnetic stimulation