Spinal Stimulation + FES-Assisted Cough Training in SCI
2026년 7월 1일 업데이트: Milap Sandhu
Combined Transcutaneous Spinal Stimulation + FES-Assisted Cough Training in Acute SCI
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) is an effective intervention to improve cough strength and coordination in individuals with acute/subacute SCI.
연구 개요
상태
상태
초대로 등록
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
60
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
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Illinois
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Chicago, Illinois, 미국, 60611
- Shirley Ryan Abilitylab
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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가짜 비교기: 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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활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Peak Cough Flow
기간: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
|
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
기간: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
|
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.
|
From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Maximum inspiratory pressure
기간: 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
기간: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
|
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
기간: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
|
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)
|
From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
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Forced expiratory volume
기간: 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)
|
From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Milap Sandhu, PhD, PT, Shirley Ryan Abilitylab
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 6월 15일
기본 완료 (추정된)
기본 완료
2029년 6월 1일
연구 완료 (추정된)
연구 완료
2030년 1월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 12일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 1일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 6일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 1일
마지막으로 확인됨
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- STU00225588
- 1529723 (기타 보조금/기금 번호: Craig H. Neilsen Foundation)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Upon request, de-identified data may be shared by the principal investigator
IPD 공유 기간
Until 3 years following conclusion of study procedures
IPD 공유 액세스 기준
Principal investigator will retain this access and distribute upon request
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .