Paired VNS For TBI Rehabilitation (VNS for TBI)
This study is evaluating whether pairing vagus nerve stimulation (VNS) with structured upper limb rehabilitation therapy can improve arm and hand function in individuals with moderate to severe traumatic brain injury (TBI).
Many people who survive a TBI experience long-term weakness, poor coordination, and difficulty using one arm or hand. These motor impairments can significantly affect independence and quality of life. Traditional rehabilitation can help, but recovery is often incomplete.
Vagus nerve stimulation (VNS) is an FDA-approved therapy for certain neurological conditions and involves a small device implanted under the skin in the chest with a lead connected to the vagus nerve in the neck. The device delivers mild electrical pulses to the nerve. In this study, VNS will be paired with goal-directed upper limb rehabilitation exercises. The stimulation is delivered during specific movements in therapy sessions. This "paired stimulation" approach is designed to enhance neuroplasticity - the brain's ability to reorganize and form new connections - which may improve motor recovery.
The VNS device used in this study is FDA-approved for other conditions. However, its use paired with rehabilitation for upper limb recovery after traumatic brain injury is investigational.
Participants in this study will:
Undergo surgical implantation of the VNS device.
Participate in structured upper limb rehabilitation therapy sessions where stimulation is paired with specific movements.
Complete follow-up visits and assessments to measure changes in arm and hand function, strength, dexterity, and overall recovery.
The main goal of the study is to determine whether paired VNS and rehabilitation improves upper limb motor function compared to rehabilitation alone. Safety will also be closely monitored, including surgical outcomes and any device-related effects.
This study may help determine whether VNS paired with rehabilitation is a safe and effective way to enhance motor recovery after traumatic brain injury. Findings from this research could contribute to improved treatment strategies for individuals living with long-term motor impairments following TBI.
Participation is voluntary. All participants will be carefully evaluated to determine eligibility, and informed consent will be obtained before enrollment.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Sima Mofakham, PhD
- 電話番号：631-444-1278
- メール：sima.mofakham@stonybrookmedicine.edu
参加基準
適格基準
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:
- Age 22-80 years
- History of severe TBI (initial GCS ≤ 8)
- Regained consciousness with capacity to consent to the study
- At least six months since injury
- Full recovery of consciousness with command following (mGCS = 6)
- Ongoing motor impairment with dependence in activities of daily living (modified Rankin Scale, mRS = 3-4)
- Clinically stable for VNS implantation
Exclusion Criteria:
- No capacity to consent to the study
- History of stroke
- History of cognitive disorder or other neurodegenerative disorder
- History of epilepsy treated by VNS
- History of brain tumors (primary or metastatic)
- Requires diathermy
- Pregnant
- Previously implanted vagus nerve stimulator
- Extensive prior neck surgery preventing dissection of the vagus nerve
- History of severe spasticity, vagus nerve damage, or hearing loss
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：VNS Group
Group to be implanted with VNS devices
|
Group will be implanted with VNS device for chronic TBI
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Device- or Procedure-Related Adverse Events
時間枠：6 Weeks
|
Adverse events related to VNS device implantation or stimulation will be recorded and graded using CTCAE v5.0.
|
6 Weeks
|
|
Change in Upper Limb Range of Motion as Assessed by SeeMe Movement Analysis
時間枠：6 Weeks
|
Video-based kinematic analysis of upper limb range of motion, comparing baseline (pre-surgery) to post-training (6 weeks after VNS-paired rehabilitation).
|
6 Weeks
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Disability Rating Scale (DRS) Score
時間枠：1 Year
|
RS score (range 0 [no disability] to 29 [extreme vegetative state]; lower scores indicate better outcome).
Magnitude of change will be used to estimate effect size for power calculation in a future multicenter randomized trial.
|
1 Year
|
|
Change in Coma Recovery Scale-Revised (CRS-R) Score
時間枠：6 Weeks
|
CRS-R total score (range 0-23; higher scores indicate better neurobehavioral function), comparing baseline to post-training.
|
6 Weeks
|
|
Change in Wolf Motor Function Test (WMFT) Performance Time
時間枠：6 Weeks
|
Time (seconds) to complete standardized WMFT tasks; lower time indicates better function.
Comparing baseline to post-training.
|
6 Weeks
|
|
Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) Score
時間枠：6 Weeks
|
FMA-UE score (range 0-66; higher scores indicate better motor function), comparing baseline to post-training.
|
6 Weeks
|
|
Change in Motor Activity Log (MAL) Score
時間枠：1 Year
|
MAL Amount of Use and Quality of Movement subscales (range 0-5 each; higher scores indicate better real-world arm use).
|
1 Year
|
|
Change in EQ-5D-5L Index Score
時間枠：1 Year
|
EQ-5D-5L index score (range 0 [death] to 1 [full health]; higher scores indicate better quality of life).
|
1 Year
|
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)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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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