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.
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Rachel E Cowan, PhD
- 전화번호: 2059345034
- 이메일: recowan@uabmc.edu
연구 연락처 백업
- 이름: Christopher Williamson, MBA
- 전화번호: 2059343776
- 이메일: cmwilliamson@uabmc.edu
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35233
- University of Alabama at Birmingham
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연락하다:
- Rachel E Cowan, PhD
- 전화번호: 2059345034
- 이메일: recowan@uabmc.edu
-
연락하다:
- Rachel
- 전화번호: 2059345034
- 이메일: recowan@uabmc.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Phase 1 Hypotension Symptoms Immediately before taVNS is applied
기간: Immediately before Phase 1 taVNS application
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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 before Phase 1 taVNS application
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Phase 1 Hypotension Symptoms during taVNS spplication
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Phase 1 Blood Pressure Immediately before taVNS is applied
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Rachel E Cowan, PhD, University of Alabama at Birmingham
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- IRB-300015896
- UAB (기타 식별자: UAB)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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