脳卒中後の腕機能の回復のための対病変抑制性rTMS (ConTRAstroke)
非侵襲的脳刺激による試験のためのカナダのプラットフォーム: 脳卒中後の腕機能の回復のための対病変抑制性 rTMS - 実現可能性試験 (Canstim: ConTRA-Stroke-F)
The CanStim consensus working group (multidisciplinary team of experts in rTMS from institutions across Canada) developed consensus recommendations for a protocol to deliver rTMS as an adjunct to a standard behavioral intervention to improve functional outcomes after stroke in a national stroke rehabilitation clinical trial. The overall goal of this multi-center feasibility trial is not to demonstrate that rTMS is effective, but to demonstrate that each site can recruit the assigned number of patients within a certain period, perform the stimulation procedure in conjunction with the protocol-specified intervention, complete the therapy protocol and enter complete datasets for each patient into the CanStim database. A secondary aim is to identify potential weaknesses of the consensus protocol that may need to be modified before performing a larger scale trial testing for the efficacy of the intervention. A tertiary goal is to examine sex differences in neurophysiological recovery (motor evoked potential and arm functional movement recovery) after 15 treatment sessions of repetitive transcranial magnetic stimulation (rTMS) and to identify sex and gender-related factors that predict the post-stroke recovery.
調査の概要
状態
条件
詳細な説明
Rehabilitation is critical for reducing stroke-related disability. Although intensive physiotherapy improves function after a stroke, the frequency and intensity of therapy in a standard clinical rehabilitation session is insufficient to invoke these changes. Transcranial magnetic stimulation (TMS) is a safe, non-invasive method of stimulating the human brain. Repetitive TMS (rTMS) may have the potential to enhance the brain's ability to re-learn specific functions and reduce the amount of standard therapy required to achieve certain functional gains after stroke. Although two recent multicenter studies have begun to test the benefits of applying rTMS during stroke rehabilitation, large scale clinical trials demonstrating the efficacy of rTMS for post-stroke functional motor recovery are lacking. The use of rTMS interventions in stroke rehabilitation trials has been limited by a lack of consensus regarding the optimal protocol for the clinical application of TMS in stroke populations. The Canadian Platform for Trials in Non-Invasive Brain Stimulation (CanStim) is a national platform that aims to facilitate multicenter clinical trials for non-invasive brain stimulation interventions to augment recovery from stroke. As a first step, CanStim investigators convened a multidisciplinary team of experts in rTMS from institutions across Canada to form the CanStim Consensus Working Group and develop consensus recommendations for a protocol to deliver rTMS as an adjunct to standard therapy in a national stroke rehabilitation clinical trial.
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
-
-
Quebec
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Montreal、Quebec、カナダ、H3T 1E2
- Jewish General Hospital
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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: patients with first ischemic stroke between 2 weeks and 3 months of stroke onset, patients with both cortical and subcortical infarcts, age between 18 and 90 years, English or French as language of daily use, patients must be able to participate in a standard of care upper extremity therapy program and must be able to perform the GRASP AND should have a minimum deficit that they can improve (e.g., <= 56 on FM UE). For the cognitively impaired patients, we will not exclude those with a higher upper limb mobility function. The patients with cognitive complaints, will only be included if they have a score of <24 on the Montreal Cognitive Assessment (MoCA).
- Exclusion criteria: prior symptomatic ischemic or hemorrhagic stroke, severe comprehension deficit that may compromise informed consent or understanding of instructions, contraindications to MRI and/or TMS, neurodegenerative or psychiatric disease, epilepsy, or EEG-documented epileptic discharges, chronic renal or liver failure, life-threatening diseases limiting life expectancy to less than 6 months and auditory or visual deficits that cannot be corrected and might impair testing. We will not exclude patients with higher upper limb mobility function.
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
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：Active rTMS
Sub-acute stroke patients will be randomized to receive actual rTMS treatment. 1Hz rTMS will be applied over contralesional M1 at an intensity of 120% resting motor threshold once daily for 30 minutes (approximately 1800 pulses) for a total of 15 sessions. |
Patients randomized to receive actual rTMS treatment will receive 1Hz rTMS applied over contralesional M1 at an intensity of 120% resting motor threshold once daily for 30 minutes (approximately 1800 pulses) for a total of 15 sessions. |
|
偽コンパレータ：Sham control
Sub-acute stroke patients randomized to receive sham rTMS. For sham-stimulation, the TMS coil will be placed over the inter-hemispheric fissure at the vertex and stimulation will be performed with low intensity (10% resting motor threshold). This will cause similar skin sensations as real stimulation but will not induce currents in motor relevant areas. |
For sham-stimulation, the TMS coil will be placed over the inter-hemispheric fissure at the vertex and stimulation will be performed with low intensity (10% resting motor threshold). This will cause similar skin sensations as real stimulation but will not induce currents in motor relevant areas. |
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 in the Fugl-Meyer Upper Arm Assessment between baseline, Post Day 1 and Post Day 30
時間枠：Baseline Testing done within the first three days then at 1 and 30 days post treatment. The Fugl Meyer has a minimum score of 0 and maximum score of 66. The higher the score the better the outcome.
|
Index to assess sensorimotor impairment in stroke. |
Baseline Testing done within the first three days then at 1 and 30 days post treatment. The Fugl Meyer has a minimum score of 0 and maximum score of 66. The higher the score the better the outcome.
|
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Change in the Action Research Arm Test between baseline, Post Day 1 and Post Day 30
時間枠：Baseline Testing done within the first three days then at 1 and 30 days post treatment. The test is scored from 0-57. The higher the score the better the outcome.
|
An evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia. It can assess a patients ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation. |
Baseline Testing done within the first three days then at 1 and 30 days post treatment. The test is scored from 0-57. The higher the score the better the outcome.
|
|
Change in the Modified Rankin Scale between baseline, Post Day 1 and Post Day 30
時間枠：Baseline Testing done within the first three days then at 1 and 30 days post treatment. The scale is between 0-6. Zero being no symptoms to 6 the patient is dead. The lower the score the better the outcome.
|
It is a scale for measuring the degree of disability or dependence in the activites of daily living in individuals who have suffered a stroke. |
Baseline Testing done within the first three days then at 1 and 30 days post treatment. The scale is between 0-6. Zero being no symptoms to 6 the patient is dead. The lower the score the better the outcome.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in the Canadian Occupational Performance Measure between baseline, Post Day 1 and Post Day 30
時間枠：Baseline Testing done within the first three days then at 1 and 30 days post treatment. Two scores are obtained from each participant, one for performance and one for satisfaction. Each are scored between 0-10. The higher the value the better.
|
This measure serves to identify issues of personal importance to the client and to detect changes in a client's self-perception of occupational performance over time. |
Baseline Testing done within the first three days then at 1 and 30 days post treatment. Two scores are obtained from each participant, one for performance and one for satisfaction. Each are scored between 0-10. The higher the value the better.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sex and Gender Questionnaire
時間枠：2 years
|
In alignment with the feasibility endpoint for the ConTRAstroke trial, the sex and gender sub-study is the feasibility of obtaining sex and gender measures across sites and the descriptive values of both blood-based biomarkers by sex and gender identity scores (as measured by the assessment tool). |
2 years
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：ALEXANDER THIEL, MD, Phd、Jewish General Hospital
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
本研究に関する用語
キーワード
その他の研究ID番号
- MP-05-2020-1891
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