Combined Neural and Behavioral Therapies to Enhance Stroke Recovery
Combining Neural and Behavioral Therapies to Enhance Stroke Recovery
調査の概要
詳細な説明
Limited recovery of upper extremity (UE) function post-stroke continues to be one of the greatest challenges faced in neurorehabilitation. There is an urgent unmet need to identify effective approaches to drive UE recovery in this population. In response to this challenge, the overall purpose of this proposed research plan is to develop rehabilitation interventions that restore UE motor recovery. Contemporary approaches to motor rehabilitation are based on evidence that behavioral experience drives cortical reorganization following neural injury. Although the rationale of driving the damaged motor cortex by focused training of the paretic UE appears straightforward, and has historically been the focus of rehabilitation, functional recovery remains limited. There remains a gap between this central neurobiological change and a meaningful behavioral change. There is a need, therefore, to augment or potentiate behavioral experience. This proposal will address this gap by examining two potential drivers of the lesioned hemisphere: 1) the non-lesioned hemisphere via engagement of the unaffected UE in behavioral training and 2) stimulation of the lesioned hemisphere via repetitive Transcranial Magnetic Stimulation (rTMS). This proposal builds on the foundation of the applicant's previous work which suggested that the contralesional, intact, hemisphere could be used to drive the lesioned hemisphere through bimanual movement. Additionally, it is possible to drive the lesioned hemisphere externally using rTMS to enhance cortical stimulation. Thus, pairing externally-driven enhancement of cortical excitability with internally-driven activation of the intact hemisphere during bilateral movements could combine to further increase excitability in the lesioned hemisphere and manifest improved movement capability of the paretic UE. The fundamental hypothesis guiding this proposal is that increased excitability of the lesioned cortex will improve behavioral function of the paretic UE post-stroke. To investigate the overall hypothesis the investigators will examine these drivers of cortical excitability and their role in UE recovery by addressing the following aims:
Specific Aim 1. Determine the magnitude of difference in central and behavioral changes in individuals with post-stroke hemiparesis randomized to a bilateral versus unilateral UE motor training program.
Specific Aim 2a. Determine the magnitude of difference in central and behavioral changes in individuals with post-stroke hemiparesis randomized to behavioral UE training compared to behavioral UE training + rTMS.
Specific Aim 2b. Determine the differential effects of rTMS on bilateral behavioral training compared to unilateral behavioral training as measured both centrally and behaviorally in individuals with post-stroke hemiparesis Post-stroke upper limb paresis and resultant loss of functional ability continues to present a barrier to those post-stroke in returning to full societal participation. Interventions that directly target the mechanism of hemiparesis, including decreased excitability of the lesioned hemisphere, are most likely to promote true recovery as opposed to the oft observed functional compensation in these individuals.
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
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Florida
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Gainesville、Florida、アメリカ、32608
- North Florida/South Georgia Veterans Health System, Gainesville, FL
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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:
- Diagnosis of 1st stroke > 6 months
- Sub-cortical stroke confirmed with CT or MRI
- Passive range of motion in bilateral shoulder and elbow within functional limits
- UE Fugl-Meyer shoulder/elbow subcomponent score between 15 - 25
- 18-80 years of age
Exclusion Criteria:
- Use of medications that may lower seizure threshold
- History of epilepsy, brain tumor, learning disorder, mental retardation, drug or alcohol abuse, dementia, major head trauma, or major psychiatric illness
- evidence of epileptiform activity on EEG obtained before beginning treatment
- history or radiographic evidence of arteriovenous malformation, intracortical hemorrhage, subarachnoid hemorrhage, or bilateral cerebrovascular disease,
- history of cortical stroke
- history of implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull
- pregnancy
- pain in either upper extremity that would interfere with movement
- unable to understand 3-step directions
- orthopedic condition in back or UE or impaired corrected vision that would alter kinematics of reaching
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 |
---|---|
実験的:Real rTMS
Real rTMS + unimanual paretic UE training
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rTMS application to lesioned hemisphere; 10 Hz, 1000 pulses
UE exercise for 4 hours (two hours 1:1 with therapist and two hours independent at home) for 16 sessions (4 sessions/week for 4 weeks)
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アクティブコンパレータ:Sham rTMS
Sham rTMS + unimanual paretic UE training
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UE exercise for 4 hours (two hours 1:1 with therapist and two hours independent at home) for 16 sessions (4 sessions/week for 4 weeks)
sham rTMS application to lesioned hemisphere; 10 Hz, 1000 pulses
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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 |
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Wolf Motor Function Test Change
時間枠:Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)
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Change, in seconds, between Pre-intervention and post-intervention (4 wks following pre-intervention).
The time to complete 15 separate upper extremity functional tasks are recorded.
These 15 separate timed events are averaged to provide one time, in seconds.
This is considered an Activity Measure on the WHO ICF model.
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Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Upper Extremity Fugl-Meyer Motor Assessment Change
時間枠:Change Between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)
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Change in Score from Pre-intervention to Post-Intervention.
This outcome measures arm motor control; the ability to move outside of pathologic synergistic patterns.
It is a measure of impairment in Body Structure/Function.
Total score ranges from 0-66, with 0 indicative of no movement and 66 considered normal motor control.
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Change Between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)
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Grip Strength Change
時間枠:Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)
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Change in Paretic hand grip strength from pre- to post-intervention.
Grip strength measured by hand-held dynamometer.
An average of 3 5-second trials was used for analysis.
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Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)
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Motor Activity Log - Amount of Use Change
時間枠:Change Between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)
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Self-Report Amount of Use of Paretic UE to complete 30 functional tasks.
Each task is reported on a 0-5 scale with "0" representing "did not use my paretic hand at all for that task" and "5" representing "I used my paretic hand as much as before the stroke to complete that task."
A "5" on each task would be considered "normal."
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Change Between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)
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Motor Activity Log - How Well Change
時間枠:Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)
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Self-Report of How Well paretic UE performed completing 30 functional tasks.
Each task is reported on a 0-5 scale with "0" representing "Unable to use my paretic hand to perform that task" and "5" representing "My paretic hand performs that task as well as it did before the stroke."
A "5" on each task would be considered "normal."
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Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)
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協力者と研究者
捜査官
- 主任研究者:Dorian Kay Rose, PhD MS BS、North Florida/South Georgia Veterans Health System, Gainesville, FL
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
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Real rTMSの臨床試験
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Arizona State UniversityUniversidad Autonoma de Nuevo Leon; Instituto Nacional Psiquiatrico de México - Ciudad de México と他の協力者完了
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Mathematica Policy Research, Inc.Office of Population Affairs, Department of Health and Human Services完了
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Campus Bio-Medico UniversityUniversity of Rome Tor Vergata; University Hospital of Ferrara; Arcispedale Santa Maria Nuova-IRCCS と他の協力者終了しました