Spinal Stimulation + FES-Assisted Cough Training in SCI
Combined Transcutaneous Spinal Stimulation + FES-Assisted Cough Training in Acute SCI
調査の概要
詳細な説明
The overall objective of this proposal is to determine if transcutaneous spinal cord stimulation (tSCS) delivered concurrently with functional electrical stimulation (FES)-assisted cough training (FES-Cough) can synergistically improve cough strength and coordination in individuals with acute/subacute SCI. Aim 1: Determine the efficacy of tSCS combined with FES-Cough in individuals with acute/subacute SCI to improve cough strength and respiratory function. Spirometric values and respiratory pressures will be assessed as well as breathlessness and hypophonia after 20 sessions of active tSCS combined with FES-Cough vs. sham tSCS combined with FES-Cough administered over 4-6 weeks Aim 2: Analyze the effect of tSCS combined with FES-cough on cough coordination and sequencing through a detailed analysis of cough partial expiratory flow-volume (CPEFV) curves and respiratory muscle EMG before and after each of the interventions, including comparative analysis of EMG cough activity between individuals with neurologic injury and healthy control participants.
Th hypothesis is that participants receiving tSCS + FES-Cough will demonstrate significantly greater improvements in unstimulated peak cough flow, normalized cough phase timing, and improved flow-volume characteristics compared to the sham + FES-Cough group.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Illinois
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Chicago、Illinois、アメリカ、60611
- Shirley Ryan Abilitylab
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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:
- Currently admitted for inpatient rehabilitation at Shirley Ryan AbilityLab
- History of traumatic spinal cord injury with Neurologic Level of Injury (NLI) C1-T1, and AIS A-C on admission exam
- Between 14-60 days from date of injury at time of enrollment
- Baseline PCF below 270 L/min
- Anatomical airway or tolerating occlusion of tracheostomy with either a one-way speaking valve or a cap for at least 60 minutes
- Medically cleared by the participants primary inpatient physiatry attending physician
Exclusion Criteria:
- Individuals with pre-morbid chronic pulmonary conditions, day-time ventilator dependence, uncontrolled autonomic dysreflexia, moderate to severe traumatic brain injury, developmental delay, diagnosis of active cancer, or secondary progressive neurologic disorder
Individuals with contraindications to the interventions of interest:
- TSCS and Abdominal FES: pacemaker, compromised skin integrity under site of stimulation, implanted defibrillators, deep brain stimulator(s), uncontrolled epilepsy or seizures, pregnancy, recent myocardial infarct, diaphragmatic pacer
- TSCS: Severe osteoporosis
- Abdominal FES: unhealed rib fracture, sternal precautions, recent pneumothorax, spine bracing impacting ability to place stimulation pads.
- Individuals with medical instability impacting the safety and feasibility of participation including the inability to tolerate sitting upright >45 degrees for 15 minutes, acute unresolved medical complications as determined by study physician to be exclusionary, transferred to higher level of medical care for ≥5 consecutive days or >14 days total during trial period, and those with halo spine bracing
- Individuals who are currently enrolled in another interventional research study are excluded from participating to eliminate potential influence of additional experimental interventions on study outcomes and to maintain standardization of study protocol
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 |
|---|---|
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偽コンパレータ：Sham tSCS + FES-Assisted Cough
In this group, the tSCS spinal stimulation will be sham, providing no additional electrical input, while the FES assisted cough intervention will remain
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A clinician will don the electrodes on the participant for 20, 30 minute sessions 2 to 4 times per week for 4 to 6 weeks.
tSCS will utilize multi-site stimulation at C3-C4 and T9-10, with simulation intensity being set for each electrode which produces a visible muscle twitch.
The sham group will have intensity will be ramped up to sensation for 1 minute then ramped down and turned off FES will be set up by placing electode pads in the posterolateral positon on the trunk.
Baseline stimulation parameters are 50Hz Frequency, 250-400μs pulse duration, altering monophasic waveform, amplitude dependent on participant response.
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アクティブコンパレータ：tSCS + FES-Assisted Cough
This group will receive the combination of tSCS spinal stimulation and FES assisted cough simultaneously
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A clinician will don the electrodes on the participant for 20, 30 minute sessions 2 to 4 times per week for 4 to 6 weeks. tSCS will utilize multi-site stimulation at C3-C4 and T9-10, with simulation intensity being set for each electrode which produces a visible muscle twitch. FES will be set up by placing electode pads in the posterolateral positon on the trunk. Baseline stimulation parameters are 50Hz Frequency, 250-400μs pulse duration, altering monophasic waveform, amplitude dependent on participant response. |
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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Peak Cough Flow
時間枠：From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
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Assesses functional cough strength via a digital peak flow by asking the participant to cough three times into the device.
The maximum number will be recorded.
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From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
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Cough Partial Expiratory Flow Volume
時間枠：From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
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Assesses the effectiveness of a cough by plotting airflow during the cough against lung volume, and allowing all phases of cough to be visualized and calculate spirometric measurements.
The participant will be fit with a facemask that will go over their nose and mouth, and then be asked to perform a series of single coughs and sequential coughs.
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From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
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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 |
|---|---|---|
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Maximum inspiratory pressure
時間枠：From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
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Assesses respiratory muscle strength by asking the participants to inhale or exhale quickly with their lips sealed around the mouthpiece of the training device to find maximum inspiratory pressure (MIP)
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From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
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Changes in electromyography (EMG) of respiratory muscles
時間枠：From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
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Assesses respiratory muscle activation during the cough.
We will use surface EMG electrodes placed on various respiratory muscles on the abdomen and upper trunk to plot muscle activation during single and sequential cough epochs.
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From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
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Maximum expiratory pressure
時間枠：From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
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Assesses respiratory muscle strength by asking the participants to inhale or exhale quickly with their lips sealed around the mouthpiece of the training device to find maximum expiratory pressure (MEP)
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From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
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Forced expiratory volume
時間枠：From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
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Assesses respiratory muscle strength by asking the participants to inhale or exhale quickly with their lips sealed around the mouthpiece of the training device to find forced expiratory volume in the first second (FEV1)
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From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Milap Sandhu, PhD, PT、Shirley Ryan Abilitylab
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
- STU00225588
- 1529723 (その他の助成金/資金番号：Craig H. Neilsen Foundation)
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
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
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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