HF-rTMS Primed Balance Training on Corticomotor Excitability, Balance, and Gait in Parkinson's
Effects of High-frequency Repetitive Transcranial Magnetic Stimulation-primed Balance Training on Corticomotor Excitability, Balance, and Gait Performance in Parkinson's Disease
調査の概要
状態
詳細な説明
This study plans to recruit 20 patients with Parkinson's disease. The experimental design is a double-blinded, randomized controlled trial, where neither the participants nor the evaluators will know the group assignments. All participants will receive rTMS "activation" followed by a modified Otago exercise program (balance training) specifically targeting Parkinson's disease. The intervention will last for 5 weeks, with sessions twice a week, totaling 10 treatments.
Before the intervention, participants will be randomly and evenly assigned to two groups: a high-frequency stimulation group (HF-rTMS) and a sham control group. This study will use the "Magstim Rapid² TMS system" for repetitive transcranial magnetic stimulation provided by the Department of Rehabilitation at Chung Shan Medical University Hospital.
For the sham control group, based on recommendations from previous related studies, participants will receive the same stimulation intensity as the experimental group, but the treatment coil will be placed on the head rotated by 90°, minimizing possible neurophysiological responses. This approach ensures a safe and humane experimental design.
Additionally, assessments will be conducted before the intervention, after all treatment sessions are completed, and at a one-month follow-up.
After completing the pre-test, the subjects will be randomly assigned to receive either high-frequency or sham rTMS treatment. The stimulation site is based on several recent systematic reviews and meta-analyses investigating the effects of repetitive transcranial magnetic stimulation on motor symptoms of Parkinson's disease (Conte D et al., 2025; Yang et al., 2018; Li et al., 2022), targeting the bilateral primary motor cortex for the lower limbs (M1-LL). The treatment lasts approximately 25 minutes. Immediately after the magnetic stimulation treatment, a 60-minute modified Otago exercise program (balance training) will be conducted. The balance training will be guided by a professional physical therapist.
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Diagnosed with idiopathic PD
- Aged between 40-80 years
- Stable on antiparkinsonian medication ( > 3 months)
- H&Y I-III
- Able to walk continuously for at least 10 minutes
- The ability to follow commands and instructions
Exclusion Criteria:
- Neurological diseases other than PD
- Severe musculoskeletal, cardiopulmonary disorders
- MMSE < 24
- Contraindications for TMS
- Have undergone or are scheduled to undergo neurological surgery during the study participation period
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：High-frequency rTMS + balance training
Frequency: 10 Hz; Intensity: 90% RMT; Duration: 4 seconds; Rest time: 26 seconds; Sets: 25; Number of pulses: 1000*2; Total time: 25 minutes Followed by an improved Otago exercise program (60 minutes)
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A painless, non-invasive, and well-tolerated non-pharmacological treatment method-Repetitive Transcranial Magnetic Stimulation (rTMS)-delivers repeated and systematic magnetic field stimulation to specific brain regions through a stimulation coil placed on the scalp.
These repeated magnetic pulses not only alter the excitability of the targeted area but also affect anatomically connected brain regions.
The parameters are as follows: Frequency: 10 Hz; Intensity: 90% RMT; Duration: 4 seconds; Rest: 26 seconds; Trains: 25 times; Pulses: 1000*2; Total time: 25 minutes.
|
|
偽コンパレータ：Sham rTMS + balance training
The stimulation parameters were the same as those of the experimental group, with only the stimulation coil rotated 90° to minimize the neurophysiological effects. Followed by an improved Otago exercise program (60 minutes) |
In this study, the sham stimulation group was designed based on previous related research and expert recommendations.
Participants in this group will receive 20% of the stimulation intensity used in the treatment group, which is significantly lower than the treatment group's 90%, ensuring a safe and humane experimental design.
The parameters are as follows: Frequency: 10 Hz; Intensity: 20% RMT; Duration: 4 seconds; Rest: 26 seconds; Trains: 25 times; Pulses: 1000*2; Total time: 25 minutes.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Corticospinal inhibition : Cortical silent period (CSP) (ms)
時間枠：Baseline, week 5 and follow-up 1 month
|
Cortical silent period (CSP) measured by Transcranial Magnetic Stimulation (TMS), with higher ms indicating stronger corticospinal inhibitory effect
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Baseline, week 5 and follow-up 1 month
|
|
Intracortical inhibition : Short-interval intracortical inhibition (SICI) (%)
時間枠：Baseline, week 5 and follow-up 1 month
|
Short-interval intracortical inhibition (SICI) measured by Transcranial Magnetic Stimulation (TMS), with higher percentage indicating stronger intracortical inhibitory effect
|
Baseline, week 5 and follow-up 1 month
|
|
Mini-Balance Evaluation Systems Test (Mini-BESTest)
時間枠：Baseline, week 5 and follow-up 1 month
|
Mini-Balance Evaluation Systems Test (Mini-BESTest) is used to assess balance performance.
Total scores range from 0 to 28, with higher scores indicating better balance and functional mobility.
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Baseline, week 5 and follow-up 1 month
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Falls Efficacy Scale-International (FES-I)
時間枠：Baseline, week 5 and follow-up 1 month
|
Falls Efficacy Scale-International (FES-I) is used to assess confidence in balance.
Total scores range from 16 to 64, with higher scores indicating more balanced confidence
|
Baseline, week 5 and follow-up 1 month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Gait speed (m/s) measured by GAITRite
時間枠：Baseline, week 5 and follow-up 1 month
|
Baseline, week 5 and follow-up 1 month
|
|
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Step length (m) measured by GAITRite
時間枠：Baseline, week 5 and follow-up 1 month
|
Baseline, week 5 and follow-up 1 month
|
|
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Movement Disorder Society-Unified Parkinson's Disease Rating Scale, Part III: Motor Examination (MDS-UPDRS-III)
時間枠：Baseline, week 5 and follow-up 1 month
|
MDS-UPDRS-III is used to assess motor symptoms in patients with Parkinson's disease.
Total scores range from 0 to 132, with higher scores indicating more severe motor symptoms.
|
Baseline, week 5 and follow-up 1 month
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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