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

NCT ID: NCT06415682

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-08
• Study Completion Date: 2025-03-31

Brief Summary

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.

Detailed 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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

SMA+M1 Transcranial Magnetic Stimulation

Intervention Type: DEVICE

The M1 stimulation session consisted 40 trains of 10-Hz rTMS with the protocol of 5s train session and 25s intertrain intervals. There were 4000 pulses per day for M1-LL (unilateral stimulation 2000 pulses). For SMA stimulation, a 5s burst of 10Hz rTMS was repeated 20 times (1000 pulse, 20 minutes' duration).

Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex (M1) of the lower leg and supplementary motor area (SMA).

single-site high frequency rTMS over the bilateral M1 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

M1 Transcranial Magnetic Stimulation

Intervention Type: DEVICE

The M1 stimulation session consisted 40 trains of 10-Hz rTMS with the protocol of 5s train session and 25s intertrain intervals. There were 4000 pulses per day for M1-LL (unilateral stimulation 2000 pulses). 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.

sham magnetic stimulation on the bilateral M1 of the lower leg

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

Group Type: SHAM_COMPARATOR

Sham Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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

Interventions

SMA+M1 Transcranial Magnetic Stimulation

The M1 stimulation session consisted 40 trains of 10-Hz rTMS with the protocol of 5s train session and 25s intertrain intervals. There were 4000 pulses per day for M1-LL (unilateral stimulation 2000 pulses). For SMA stimulation, a 5s burst of 10Hz rTMS was repeated 20 times (1000 pulse, 20 minutes' duration).

Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex (M1) of the lower leg and supplementary motor area (SMA).

Intervention Type: DEVICE

M1 Transcranial Magnetic Stimulation

The M1 stimulation session consisted 40 trains of 10-Hz rTMS with the protocol of 5s train session and 25s intertrain intervals. There were 4000 pulses per day for M1-LL (unilateral stimulation 2000 pulses). 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.

Intervention Type: DEVICE

Sham Transcranial Magnetic Stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kezhong Zhang

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

2024-SR-290

Identifier Type: -

Identifier Source: org_study_id