Motor Learning and Multi-session tDCS in Parkinson's Disease
The Effect of Multi-session Transcranial Direct Current Stimulation Applied Over the Primary Motor Cortex on Motor Sequence Learning in Parkinson's Disease
調査の概要
詳細な説明
Parkinson's disease is characterised by deficits of motor control triggered by impaired basal ganglia function, such as bradykinesia and tremor. Beyond the visibly recognisable motor symptoms of Parkinson's disease, the ability to learn a sequence of movements is also compromised and poses a significant barrier to effective rehabilitation. In healthy individuals, transcranial direct current stimulation applied over the primary motor cortex during motor task practice has been shown to significantly improve motor learning compared to placebo conditions.
The present study seeks to examine the effect of multi-session transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance. Participants will be required to attend eight laboratory sessions, comprising five intervention and three assessment sessions and will be tested on their ability to learn a 16-digit finger tapping sequence with their right hand. Sessions one to five will form the intervention and will be performed at the same time on consecutive days (i.e. mon-fri). In addition, session one will double as a baseline assessment and intervention session. Assessments sessions will be performed once before the intervention (session one), and three times following the intervention on day three, one week, and four weeks post intervention.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Hung Hom
-
Hong Kong、Hung Hom、香港
- The Hong Kong Polytechnic University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Right-handed (Edinburgh Handedness Inventory; ≥50)
- Cognitively capable (Montreal Cognitive Assessment (MoCA); ≥23)
- Mild to moderate Parkinson's disease severity (Hoehn and Yar disease stage 2-3)
- On stable dopaminergic medication
Exclusion Criteria:
- History of stroke
- Comorbidity
- Cephalic implants
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
偽コンパレータ：Sham tDCS
Anodal electrode (35 cm2 sponge electrode) placed over C3.
Cathodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area.
Stimulation was phased in for 30 seconds up to 2 mA and then switched off.
Stimulation was again phased in for 30 seconds following 20 minutes of no stimulation.
|
Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad. Stimulation is phased in with a 30-second ramp up of the electrical current to the specified stimulation parameters. Following the specified stimulation period, the current is phased-out with a ramp down of the current. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off during the specified stimulation period.
他の名前：
|
|
実験的：Anodal tDCS
Anodal electrode (35 cm2 sponge electrode) placed over C3.
Cathodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area.
20 minutes of stimulation at 2 mA with a 30-second phase-in and phase-out period.
|
Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad. Stimulation is phased in with a 30-second ramp up of the electrical current to the specified stimulation parameters. Following the specified stimulation period, the current is phased-out with a ramp down of the current. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off during the specified stimulation period.
他の名前：
|
|
実験的：Cathodal tDCS
Cathodal electrode (35 cm2 sponge electrode) placed over C3.
Anodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area.
20 minutes of stimulation at 2 mA with a 30-second phase-in and phase-out period.
|
Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad. Stimulation is phased in with a 30-second ramp up of the electrical current to the specified stimulation parameters. Following the specified stimulation period, the current is phased-out with a ramp down of the current. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off during the specified stimulation period.
他の名前：
|
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 |
|---|---|---|
|
Change from baseline: sequential finger tapping performance
時間枠：Four assessments: Baseline (pre-intervention), 3 days, 1 week, and 4 weeks post intervention. Performance is also assessed during the intervention period on each day the intervention is applied. Once immediately before and after intervention is applied.
|
A skill index reflecting the accuracy and speed that participants perform a specified finger tapping sequence.
|
Four assessments: Baseline (pre-intervention), 3 days, 1 week, and 4 weeks post intervention. Performance is also assessed during the intervention period on each day the intervention is applied. Once immediately before and after intervention is applied.
|
|
Change from baseline: shape-counting error
時間枠：Four assessments: Baseline (pre-intervention), 3 days, 1 week, and 4 weeks post intervention. Performance is also assessed during the intervention period on each day the intervention is applied. Once immediately before and after intervention is applied.
|
The percentage of shape counting error during dual task assessments.
Sequential finger tapping + visual shape counting task.
|
Four assessments: Baseline (pre-intervention), 3 days, 1 week, and 4 weeks post intervention. Performance is also assessed during the intervention period on each day the intervention is applied. Once immediately before and after intervention is applied.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline: oxygenated haemoglobin response
時間枠：Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
|
Task related changes of oxygenated haemoglobin as measured using functional near-infrared spectroscopy.
|
Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
|
|
Change from baseline: Movement Disorders Society Unified Parkinson's Disease Rating Scale Motor Section (Part 3)
時間枠：Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
|
Participants physical function is assessed according to the criteria of the Movement Disorders Society Unified Parkinson's Disease Rating Scale Motor Section (Part 3).
Minimum value = 0, maximum value = 132.
Lower scores indicate a better outcome.
|
Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
|
|
Change from baseline: upper limb motor task performance
時間枠：Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
|
Timed sequential movement of the arm and hand.
The participant sits upright on a chair that has no arm support with their arms relaxed by their side.
The time taken to perform the following sequence 10 times is recorded: 1. Close and open hand, 2) flex elbow, 3) close and open hand, 4) extend elbow.
Right and left arms are assessed separately.
|
Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
|
|
Change from baseline: Purdue pegboard task performance
時間枠：Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
|
Participants are required to pick up a metal peg and place the peg in a specified row of holes.
Pegs must be placed one at a time.
The maximum number of pegs placed within 30 seconds is recorded.
The assessment is repeated three times for each hand.
Each hand is assessed separately.
|
Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
|
協力者と研究者
捜査官
- 主任研究者：Margaret Mak, Dr、The Hong Kong Polytechnic University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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。