Pilot Testing of Vagus Nerve Stimulation for Early Spinal Cord Injury Recovery (PIVOTS-Rehab)
Pilot Investigation of Transauricular Vagal Nerve Stimulation Safety and Feasibility in Acute Incomplete Spinal Cord Injury Rehabilitation
This study looks at a treatment called transcutaneous auricular vagus nerve stimulation, or taVNS. taVNS uses a small device worn on the ear to gently stimulate a nerve. Researchers want to find out if this treatment is safe and well-tolerated for people who recently had a spinal cord injury (SCI).
This study will also help researchers learn whether taVNS can be safely added to standard mobility therapy, and whether it might help improve mobility.
This study has two main goals:
- To find out whether taVNS is safe and comfortable for people with a recent spinal cord injury.
- To get information on whether taVNS may help improve mobility when compared to people who completed rehabilitation before this study started.
This study has two parts.
In the first part, participants will wear the taVNS device once for a short period of time. During this part investigators will measure how participant's heart rate and blood pressure may change before, during, and after the stimulation. Investigators will also ask about how the stimulation made participants feel.
In the second part, participants will wear the taVNS device for a short time right before a mobility therapy session. During this part investigators will measure how participants heart rate and blood pressure may change before, during, and after the stimulation and during and after the walking therapy. Investigators will also ask about how the stimulation made participants feel.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Rachel E Cowan, PhD
- 電話番号：2059345034
- メール：recowan@uabmc.edu
研究連絡先のバックアップ
- 名前：Christopher Williamson, MBA
- 電話番号：2059343776
- メール：cmwilliamson@uabmc.edu
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35233
- University of Alabama at Birmingham
-
コンタクト：
- Rachel E Cowan, PhD
- 電話番号：2059345034
- メール：recowan@uabmc.edu
-
コンタクト：
- Rachel
- 電話番号：2059345034
- メール：recowan@uabmc.edu
-
-
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:
- Phase 1 Age 18 years older SCI (traumatic or non traumatic) undergoing initial inpatient rehabilitation for the SCI Any AIS severity level (A, B, C, D)
- Phase 2 Completed phase I Participant willing to complete phase II Study physician approves participation in phase II Receives intensive gait training as a part of the care plan
Exclusion Criteria:
- Phase 1 Age >89 years Pregnant Implanted medical device (e.g. pacemaker, cochlear implant) epilepsy Parkinson's Disease Multiple Sclerosis cerebral shunts documented arrhythmia Ear skin irritation or damage at the electrode contact location intracranial metal implants
- Phase 2 no exclusion criteria for those who meet inclusion criteria
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）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：taVNS application
This is a single arm study with two Phases. In Phase 1 taVNS will be applied bilaterally for a brief period while the individual is in inpatient rehabilitation In Phase 2 taVNS will be applied for a brief period immediately before each mobility therapy session while the period is in inpatient rehabilitation. The mobility therapy sessions are routine care. Frequency and intensity of these sessions are determined by the therapists. All individuals must complete Phase 1 before starting Phase 2. Not all individuals who complete Phase 1 will be eligible for Phase 2. Please see eligibility criteria for more details. |
bilateral transauricular vagal nerve stimulation
他の名前：
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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 |
|---|---|---|
|
Phase 1 Hypotension Symptoms Immediately before taVNS is applied
時間枠：Immediately before Phase 1 taVNS application
|
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
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Immediately before Phase 1 taVNS application
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Phase 1 Hypotension Symptoms during taVNS spplication
時間枠：During application of Phase 1 taVNS
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Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
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During application of Phase 1 taVNS
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|
Phase 1 Hypotension Symptoms Immediately after taVNS is stopped
時間枠：Immediately after Phase 1 taVNS is stopped
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Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
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Immediately after Phase 1 taVNS is stopped
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Phase 1 Hypotension Symptoms 5 minutes after taVNS is stopped
時間枠：5 minutes after Phase 1 taVNS is stopped
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Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
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5 minutes after Phase 1 taVNS is stopped
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|
Phase 1 taVNS Tolerability survey
時間枠：Within 48 hours of competing Phase 1 taVNS
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10 question survey addressing perceived sensation, tolerability, side effects, and open text response
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Within 48 hours of competing Phase 1 taVNS
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Phase 2 taVNS Tolerability survey
時間枠：Within 48 hours of completing Phase 2 taVNS
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10 question survey addressing perceived sensation, tolerability, side effects, and open text response
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Within 48 hours of completing Phase 2 taVNS
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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 |
|---|---|---|
|
Phase 1 Blood Pressure Immediately before taVNS is applied
時間枠：Immediately before taVNS Phase 1 application is applied
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Systolic and Diastolic Blood Pressure (mmHg)
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Immediately before taVNS Phase 1 application is applied
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Phase 1 Blood Pressure during taVNS application
時間枠：During taVNS Phase 1 application
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Systolic and Diastolic Blood Pressure (mmHg)
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During taVNS Phase 1 application
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Phase 1 Blood Pressure Immediately after taVNS is stopped
時間枠：Immediately after taVNS Phase 1 application is stopped
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Systolic and Diastolic Blood Pressure (mmHg)
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Immediately after taVNS Phase 1 application is stopped
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Phase 1 Blood Pressure 5 minutes after taVNS is stopped
時間枠：5 minutes after taVNS Phase 1 application is stopped
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Systolic and Diastolic Blood Pressure (mmHg)
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5 minutes after taVNS Phase 1 application is stopped
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Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Admission
時間枠：Admission to rehabilitation
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Total score on the IRF-PAI Section GG mobility.
Scores range from 15 to 90.
Extracted from the medical record
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Admission to rehabilitation
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Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Discharge
時間枠：Immediately after discharge from rehabilitation
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Total score on the IRF-PAI Section GG mobility.
Scores range from 15 to 90.
Extracted from the medical record
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Immediately after discharge from rehabilitation
|
協力者と研究者
捜査官
- 主任研究者：Rachel E Cowan, PhD、University of Alabama at Birmingham
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
- IRB-300015896
- UAB (その他の識別子：UAB)
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
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