The Efficacy and Mechanism of SMA+M1 Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in PD

Nanjing Medical University

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Sham Transcranial Magnetic Stimulation; Device: M1 Transcranial Magnetic Stimulation; Device: SMA+M1 Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06415682

2024-SR-290

Details and patient eligibility

About

This study is a double-blinded randomized study examining the efficacy of the double-site (M1+SMA) 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 double-site 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 single-site 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 group underwent 10 sessions of sham rTMS on bilateral primary motor cortex of the lower leg. Assessments of FOG severity, gait, 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.

Enrollment: 64 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. aged between 40-80 years;
2. diagnosis of idiopathic Parkinson's disease (PD) according to the Movement Disorder Society clinical diagnostic criteria;
3. patients were stable on dopaminergic treatment for at least 3 months;
4. Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1;
5. Patients experienced FOG during an interview.

Exclusion criteria

1. comorbidities of major neurologic diseases other than PD;
2. suffer from musculoskeletal disorders that could have interfered with their ability to walk;
3. presence of contraindications for transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI);
4. marked tremor interfered with TMS detection;
5. previously receiving any kinds of TMS interventions;
6. severe cognitive impairment making cooperation impossible [Mini Mental State Examination (MMSE) < 24];
7. were unable to walk independently during the OFF state.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 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: SMA+M1 Transcranial Magnetic Stimulation

single-site high frequency rTMS over the bilateral M1 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: M1 Transcranial Magnetic Stimulation

sham magnetic stimulation on the bilateral M1 of the lower leg

Sham Comparator group

Description:

Patients in the Sham Comparator group underwent ten sessions of double sham rTMS on the bilateral M1 of the lower leg.

Treatment:

Device: Sham Transcranial Magnetic Stimulation