Pilot Investigation of Transauricular Vagal Nerve Stimulation Safety and Feasibility in Acute Incomplete Spinal Cord Injury Rehabilitation
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Phase 1 Hypotension Symptoms Immediately before taVNS is applied
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Transauricular vagus nerve stimulation (Device)
结局指标
主要结局
Phase 1 Hypotension Symptoms Immediately before taVNS is applied
时间窗: 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
Phase 1 Hypotension Symptoms during taVNS spplication
时间窗: During application of Phase 1 taVNS
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Phase 1 Hypotension Symptoms Immediately after taVNS is stopped
时间窗: Immediately after Phase 1 taVNS is stopped
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Phase 1 Hypotension Symptoms 5 minutes after taVNS is stopped
时间窗: 5 minutes after Phase 1 taVNS is stopped
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Phase 1 taVNS Tolerability survey
时间窗: Within 48 hours of competing Phase 1 taVNS
10 question survey addressing perceived sensation, tolerability, side effects, and open text response
Phase 2 taVNS Tolerability survey
时间窗: Within 48 hours of completing Phase 2 taVNS
10 question survey addressing perceived sensation, tolerability, side effects, and open text response
次要结局
- Phase 1 Blood Pressure Immediately before taVNS is applied(Immediately before taVNS Phase 1 application is applied)
- Phase 1 Blood Pressure during taVNS application(During taVNS Phase 1 application)
- Phase 1 Blood Pressure Immediately after taVNS is stopped(Immediately after taVNS Phase 1 application is stopped)
- Phase 1 Blood Pressure 5 minutes after taVNS is stopped(5 minutes after taVNS Phase 1 application is stopped)
- Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Admission(Admission to rehabilitation)
- Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Discharge(Immediately after discharge from rehabilitation)
研究者
Rachel Cowan
Associate Professor
University of Alabama at Birmingham