Impact of VNS With Rehab on Gait Post-Stroke
The Impact of Vagus Nerve Stimulation Paired With Rehabilitation on Lower Limb and Gait Functions After Ischemic Stroke
調査の概要
詳細な説明
Stroke is a major cause of disability worldwide and currently there is a lack of effective treatments to improve functional capacity of patients with long-term disability. Vagus Nerve Stimulation (VNS) is FDA-approved for rehabilitation of upper limb deficits in patient with stroke. The device (including Vagus nerve electrodes and chest generator) is permanently implanted prior to the beginning of rehabilitation as standard of care. It is activated by patients and physical therapists during a period of 4.5 months of in-clinic and home therapy. However, so far there have been no approved neuromodulation treatments to improve lower limb functions and gait, which are key for patients' quality of life and their ability to integrate with work and social cycles.
This project will evaluate the impact of VNS on lower limb functions as measured by clinical and laboratory-based analyses of gait in stroke survivors. Patients with both upper and lower limb deficits will be included in this project. After the completion of the standard upper limb VNS-rehabilitation protocol, patients will be double-blindly randomized into 2 groups: a) lower limbs and gait rehabilitation with VNS ON for the duration of therapy; b) lower limbs and gait rehabilitation with VNS OFF.
Based on prior experience with upper limb deficits, we hypothesize that rehabilitation therapy coupled with VNS neuromodulation will elicit functional improvements in lower limb deficits and gait.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ellen M Carl, PhD, CCRP
- 電話番号：7260 716-218-1000
- メール：ecarl@ubns.com
研究連絡先のバックアップ
- 名前：Amylynn M Liskiewicz, MA, CCRP
- 電話番号：716-218-1000
- メール：aliskiewicz@ubns.com
研究場所
-
-
New York
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Buffalo、New York、アメリカ、14203
- 募集
- University at Buffalo Neurosurgery
-
コンタクト：
- Ellen M Carl, PhD, CCRP
- 電話番号：7260 716-218-1000
- メール：ecarl@ubns.com
-
コンタクト：
- Amylynn M Liskiewicz, MA, CCRP
- 電話番号：716-218-1000
- メール：aliskiewicz@ubns.com
-
主任研究者：
- Assaf Berger, MD
-
副調査官：
- Jonathan Riley, MD
-
副調査官：
- Sue Ann Sisto, MD
-
-
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:
- Approved for Vagus Nerve Stimulation (VNS) and rehabilitation therapy
- ≥22 years and ≤ 80 years
- Only patients who elect to undergo VNS therapy for stroke-related upper limb deficits
- Residual active movement in the affected limb's thumb and other 2 fingers
- Stroke-related deficits in the lower limbs and gait with a Functional Ambulation Category (FAC) ≥3
- Able to follow simple instructions and independently walk short distances with or without external support or leg orthoses, but without manual contact with another person
Exclusion Criteria:
- Intact lower limb functions (Fugl-Meyer score=34)
- Not a candidate for VNS therapy according to FDA guidelines
- Pregnant patients
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：VNS ON
Receives active stimulation during therapy
|
Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)
|
|
偽コンパレータ：VNS OFF
No stimulation during therapy
|
Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)
|
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 |
|---|---|---|
|
Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale
時間枠：90 days post-operation
|
Absolute change in FMA-LE from baseline to 90 days
|
90 days post-operation
|
|
Percent Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale
時間枠：90 days post-operation
|
Percent change in FMA-LE from baseline to 90 days
|
90 days post-operation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Absolute Change in Functional Assessment - 10-meter walk
時間枠：90 days post-operation
|
Absolute change in gait function as assessed by the timed 10-meter walk from baseline to 90 days
|
90 days post-operation
|
|
Percent Change in Functional Assessment - 10-meter walk
時間枠：90 days post-operation
|
Percent change in gait function as assessed by the timed 10-meter walk from baseline to 90 days
|
90 days post-operation
|
|
Absolute Change in Functional Assessment - 6-minute walk
時間枠：90 days post-operation
|
Absolute change in gait function as assessed by the 6-minute walk from baseline to 90 days
|
90 days post-operation
|
|
Percent Change in Functional Assessment - 6-minute walk
時間枠：90 days post-operation
|
Percent change in gait function as assessed by the 6-minute walk from baseline to 90 days
|
90 days post-operation
|
|
Absolute Change in Functional Assessment - Berg Balance Scale
時間枠：90 days post-operation
|
Absolute change in gait function as assessed by the Berg Balance Scale from baseline to 90 days
|
90 days post-operation
|
|
Percent Change in Functional Assessment - Berg Balance Scale
時間枠：90 days post-operation
|
Percent change in gait function as assessed by the Berg Balance Scale from baseline to 90 days
|
90 days post-operation
|
|
Absolute Change in Functional Assessment - Five Times Sit-to-Stand Test
時間枠：90 days post-operation
|
Absolute change in gait function as assessed by the Five Times Sit-to-Stand test from baseline to 90 days
|
90 days post-operation
|
|
Percent Change in Functional Assessment - Five Times Sit-to-Stand Test
時間枠：90 days post-operation
|
Percent change in gait function as assessed by the Five Times Sit-to-Stand test from baseline to 90 days
|
90 days post-operation
|
|
Absolute Change in Functional Assessment - Stroke Impact Scale
時間枠：90 days post-operation
|
Absolute change in gait function as assessed by the Stroke Impact Scale from baseline to 90 days
|
90 days post-operation
|
|
Percent Change in Functional Assessment - Stroke Impact Scale
時間枠：90 days post-operation
|
Percent change in gait function as assessed by the Stroke Impact Scale from baseline to 90 days
|
90 days post-operation
|
|
Absolute Change in Functional Assessment - 3D Motion Analysis of Gait
時間枠：90 days post-operation
|
Absolute change in gait function as assessed by the 3D Motion Analysis of Gait from baseline to 90 days
|
90 days post-operation
|
|
Percent Change in Functional Assessment - 3D Motion Analysis of Gait
時間枠：90 days post-operation
|
Percent change in gait function as assessed by the 3D Motion Analysis of Gait from baseline to 90 days
|
90 days post-operation
|
協力者と研究者
捜査官
- 主任研究者：Assaf Berger, MD、University at Buffalo
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
本研究に関する用語
その他の研究ID番号
- STUDY00008984
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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