The Effect of rTMS Over the SMA on Gait Performance in Parkinson's Disease

The Hong Kong Polytechnic University

Status: Not yet enrolling

Conditions: PARKINSON DISEASE (Disorder)

Treatments: Device: Transcranial Magnetic Stimulation Sham; Device: Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07190235

HSEARS20250512001

Details and patient eligibility

About

This study aims to investigate the effects of high-frequency and low-frequency repetitive transcranial magnetic stimulation (rTMS) over the supplementary motor area (SMA) on gait performance, especially gait initiation, in individuals with Parkinson's disease (PD). Furthermore, the investigators will explore the impact of rTMS over the SMA on walking speed, functional mobility, and limits of stability in PD. It is hypothesized that rTMS over the SMA will improve gait performance in PD.

Full description

The goal of this clinical trial is to investigate the effects of high-frequency and low-frequency rTMS over the SMA on gait performance, especially gait initiation, in individuals with PD. The primary outcome will be anticipatory postural adjustments (APAs) during gait initiation. The secondary outcome will include walking speed, the timed up-and-go test (TUG), and limits of stability.

The hypotheses are:

1. Both 25 Hz and 1 Hz rTMS will have a significant effect on gait performance, especially the gait initiation phase, as assessed by APAs in PD, compared with sham stimulation.
2. 25 Hz and 1 Hz rTMS will have a different effect on gait initiation in PD.

This study will be a three-arm, randomized, double-blind, placebo-controlled study examining the effect of 25 Hz or 1 Hz SMA-TMS compared with that observed after sham TMS. A total of 81 individuals with PD will be recruited and allocated into three different groups: 1 Hz TMS group, 25 Hz TMS group, and sham TMS group. Participants in each group will receive 10 TMS sessions over 2 weeks. Assessors will conduct evaluations at baseline, post-intervention, and 4-week post-intervention. The primary outcome will be APAs during gait initiation. The secondary outcome will include walking speed, TUG , and limits of stability.

Enrollment: 81 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. diagnosed with PD according to thecriteria set by Movement Disorder Committee,
2. with Hoehn and Yahr stages II-III, which are recognized as representing mild to moderate disease severity,
3. have self-reported difficulty in gait initiation, assessed by item 5 of the freezing of gait questionnaire (FOGQ),
4. have used a dopaminergic medication dose in the last month,
5. a minimum score of 23 of 30 points on the Montreal Cognitive Assessment (MoCA).

Exclusion criteria

1. patients with unstable medical conditions,
2. unable to provide informed consent,
3. other neurological conditions including stroke,
4. contraindications for TMS,
5. experienced deep brain stimulation treatment,
6. no recordable motor evoked potentials (MEPs) with TMS.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 3 patient groups, including a placebo group

25 Hz repetitive transcranial magnetic stimulation group

Experimental group

Description:

High-frequency repetitive transcranial magnetic stimulation (25 Hz), intended to increase cortical excitability and provide facilitatory neuromodulation.

Treatment:

Device: Transcranial Magnetic Stimulation

1 Hz repetitive transcranial magnetic stimulation group

Experimental group

Description:

Low-frequency repetitive transcranial magnetic stimulation (1 Hz), intended to decrease cortical excitability and provide inhibitory neuromodulation.

Treatment:

Device: Transcranial Magnetic Stimulation

Sham stimulation group

Placebo Comparator group

Description:

The stimulation coil is positioned identically to active TMS and emits similar auditory and scalp sensations, but delivers no significant magnetic pulse to the brain, mimicking the active intervention experience without neuromodulatory effects.

Treatment:

Device: Transcranial Magnetic Stimulation Sham