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

Официальное название

The Effect of Repetitive Transcranial Magnetic Stimulation Over the Supplementary Motor Area on Gait Performance in Parkinson's Disease: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Transcranial Magnetic Stimulation
  The repetitive transcranial magnetic stimulation (rTMS) at different frequencies will deliver 10 sessions over 2 weeks. The participants will receive different stimulation protocols to the supplementary motor area while seated using a double-cone coil connected to a transcranial magnetic stimulator.
• Устройство Transcranial Magnetic Stimulation Sham
  The sham transcranial magnetic stimulation (TMS) will deliver 10 sessions over 2 weeks. The participants will receive the sham stimulation protocol to the supplementary motor area while seated using a double-cone coil connected to a transcranial magnetic stimulator.

Первичные конечные точки

• Change in duration of anticipatory postural adjustments (APAs) during gait initiation [Срок оценки: Baseline, 2 weeks (post-intervention)]

Вторичные конечные точки (12)

• Change in duration of anticipatory postural adjustments (APAs) during gait initiation [Срок оценки: Baseline and 6 weeks (4-week post-intervention)]
• Change in comfortable walking speed of the 10-meter walk test [Срок оценки: Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention)]
• Change in fast walking speed of the 10-meter walk test [Срок оценки: Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention)]
• Changes in Timed Up-and-Go Test (TUG) [Срок оценки: Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention)]
• Change in Unified Parkinson's Disease Rating Scale-motor examination (UPDRS-III) [Срок оценки: Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention)]
• Change in score of Mini-Balance Evaluation System Test (MiniBEST) [Срок оценки: Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention)]
• Change in freezing of gait questionnaire (FOGQ) [Срок оценки: Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention)]
• Change in the 39-item Parkinson's disease questionnaire (PDQ-39) [Срок оценки: Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention)]
• Change in resting motor threshold (RMT) [Срок оценки: Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention)]
• Change in short-interval intracortical inhibition (SICI) [Срок оценки: Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention)]
• Intracortical facilitation (ICF) [Срок оценки: Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention)]
• Changes in the slope of the stimulus response curve (SRC) [Срок оценки: Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Kowloon

Публикации

• Rahimpour S, Rajkumar S, Hallett M. The Supplementary Motor Complex in Parkinson's Disease. J Mov Disord. 2022 Jan;15(1):21-32. doi: 10.14802/jmd.21075. Epub 2021 Nov 25. PMID 34814237
• Mi TM, Garg S, Ba F, Liu AP, Wu T, Gao LL, Dan XJ, Chan P, McKeown MJ. High-frequency rTMS over the supplementary motor area improves freezing of gait in Parkinson's disease: a randomized controlled trial. Parkinsonism Relat Disord. 2019 Nov;68:85-90. doi: 10.1016/j.parkreldis.2019.10.009. Epub 2019 Oct 11. PMID 31689588
• Jacobs JV, Lou JS, Kraakevik JA, Horak FB. The supplementary motor area contributes to the timing of the anticipatory postural adjustment during step initiation in participants with and without Parkinson's disease. Neuroscience. 2009 Dec 1;164(2):877-85. doi: 10.1016/j.neuroscience.2009.08.002. Epub 2009 Aug 7. PMID 19665521
• Delval A, Tard C, Defebvre L. Why we should study gait initiation in Parkinson's disease. Neurophysiol Clin. 2014 Jan;44(1):69-76. doi: 10.1016/j.neucli.2013.10.127. Epub 2013 Oct 30. PMID 24502907
• Chen Y, Jiang H, Wei Y, Ye S, Jiang J, Mak MKY, Pang MYC, Gao Q, Huang M. Effects of non-invasive brain stimulation over the supplementary motor area on motor function in Parkinson's disease: A systematic review and meta-analysis. Brain Stimul. 2025 Jan-Feb;18(1):1-14. doi: 10.1016/j.brs.2024.12.005. Epub 2024 Dec 11. PMID 39667490
• Armstrong MJ, Okun MS. Diagnosis and Treatment of Parkinson Disease: A Review. JAMA. 2020 Feb 11;323(6):548-560. doi: 10.1001/jama.2019.22360. PMID 32044947

Идентификаторы

NCT: NCT07190235 · HSEARS20250512001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗