Early Feasibility Study of the ReWire System for Closed-Loop Vagus Nerve Stimulation (CLV) Paired With Rehabilitation After Spinal Cord Injury (SCI) - Lower Limb Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- ReWire System Safety
研究概览
简要总结
The purpose of this study is to evaluate the safety, feasibility, and preliminary effectiveness of the ReWire system, which delivers vagus nerve stimulation (VNS) paired with lower limb rehabilitation to improve gait in individuals with mobility impairments resulting from chronic, incomplete spinal cord injury (SCI).
详细描述
A randomized, multi-center, double-blinded sham-control early feasibility trial of participants implanted with the ReWire System for spinal cord injury (SCI) with and open label extension.
During the pre-therapy phase, participants will undergo informed consent, baseline assessment, pre-operative evaluation, surgical implantation of the ReWire system, post-surgical assessment, and randomization. Following post-surgical assessment, participants will be block randomized in a 1:1 ratio to either active CLV (Immediate start group) or sham stimulation (Delayed start group) for the double-blind phase.
In double-blind phase, participants will complete up to 18 sessions of lower limb rehabilitation paired with CLV (Immediate start group) or sham stimulation (Delayed start group). Participants will then undergo assessment after completion of all sessions.
In open-label phase, all participants will receive up to an additional 18 sessions of CLV, regardless of their assignment in the double-blind phase. Participants will then undergo assessment after completion of all sessions.
A final, follow-up assessment will be conducted approximately 4 weeks (a month) from the previous assessment and cessation of CLV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide signed and dated informed consent.
- •Willingness and ability to comply with all study procedures and protocol requirements for the duration of the study.
- •Age 18 to 64 years.
- •Chronic, non-penetrating, motor incomplete spinal cord injury [Association Impairment Scale (AIS) grade C or D] occurring ≥12 months prior to enrollment, resulting in impairment in lower limb function.
- •Ambulatory with residual gait impairment attributable to spinal cord injury.
- •Self-selected gait speed of < 0.8 m/s as measured by the 10 meter walk test.
- •Score of 2 or less on at least 4 measures on the Ambulation subsection of the SCI-Functional Independence scale (SCI-FIS).
- •In otherwise good general health as determined by medical history and physical examination.
- •Meets all clinical criteria for VNS implantation as determined by the Site PI and clinical care team.
排除标准
- •Any history of spinal cord injuries by penetrating traumatic, non-traumatic or congenital causes.
- •Evidence of right-sided recurrent laryngeal nerve injury on pre-operative laryngoscopy, if required (Note: Participants with a history of right-sided anterior cervical surgery must undergo laryngoscopy prior to surgical scheduling. A finding of right-sided recurrent laryngeal nerve injury results in exclusion).
- •Excessive scar tissue on intraoperative assessment that precludes safe implantation (Note: Participants with a history of left-sided anterior cervical surgery will undergo intraoperative assessment of scar tissue. If excessive scar tissue is deemed to preclude safe implantation, the procedure will be abandoned and the participant excluded for safety reasons. A history of left-sided anterior cervical surgery or prior recurrent laryngeal nerve injury alone does not result in exclusion).
- •Concomitant clinically significant brain injuries.
- •Deficits in language or attention that interfere with study participation.
- •Presence of any other implanted electrical stimulation device.
- •Prior injury to the vagus nerve.
- •Presence of any other implanted investigational device.
- •Neck circumference of > 18.5 inches or significant overlying tissue and/or scarring that may hinder device communication.
- •Psychiatric, psychosocial, and/or cognitive disorder or impairment that could interfere with study participation as assessed by medical evaluation.
- •Current or past: (a) medical (psychiatric, non-psychiatric) condition, disease, disorder, injury, or disability*; or (b) non-medical situation or circumstance that, in the opinion of the Site PI, study participation:
- •may pose a significant or undue risk to the person;
- •make it unlikely the person will complete all the study requirements per protocol; or
- •may adversely impact the integrity of the data or the validity of the study results.
- •[*Examples include, but are not limited to, the following types of conditions, diseases or disorders: renal insufficiency or failure, vascular disease, unstable or concerning cardiac disease, endocrinologic concerns (e.g., poorly controlled diabetes), immunosuppression, respiratory issues, psychiatric (e.g., schizophrenia), neurologic (e.g., cognitive, seizure), sickle cell disease, lupus, clotting disorders, active neoplastic disease (excluding basal or squamous cell carcinoma of the skin with intent for curative excision), recent documented history (within the last 3 months) of dysphagia or aspiration difficulty]
- •Is female and lactating, pregnant, or plans to become pregnant during the study. Participants of child-bearing potential that are sexually active must use a reliable form of birth control. Acceptable birth control methods: (a) sterilization surgery for women, (b) surgical sterilization implant for women, (c) sterilization surgery for men (including all male partners), (d) Long-acting reversible contraceptives (LARC)-implantable rod and Intrauterine Device (IUD), (e) contraceptive shots/injection every 3 months, (f) oral contraceptives (pills), (g) contraceptive patch, (h) vaginal contraceptive ring, and (i) complete abstinence.
- •Abusive use of alcohol or drugs that could interfere with participation, as determined by the Site PI.
- •Concurrently participating in another interventional clinical study.
- •Requires or plans the use of diathermy, transcranial magnetic stimulation, or electroconvulsive therapy (ECT) during the course of the study.
- •Is known to be under incarceration or legal detention as determined by the Site PI.
- •Non-English speaking, unless the enrolling site has an IRB-approved translated consent and qualified medical interpreter resources available in the participant's language to support all study visits and procedures.
研究组 & 干预措施
CLV (Immediate start group)
The participants in this arm will be implanted with the device and will receive CLV in double-blind and open-label phases of the study.
干预措施: CLV (Device)
Sham (Delayed start group)
The participants in this arm will be implanted with the device and will receive sham in double-blind phase and CLV in open-label phase of the study.
干预措施: Sham (Device)
结局指标
主要结局
ReWire System Safety
时间窗: From device implantation to up to 2 years following implantation.
Safety of the ReWire system will be assessed by documenting the nature, frequency, severity, and relatedness of adverse events associated with the device, including those attributable to device implantation, stimulation delivery, and rehabilitation procedures.
ReWire System Feasibility
时间窗: All visits after implantation, up to approximately 26 weeks post-enrollment.
Feasibility of the ReWire system will be assessed by the proportion of successful stimulation triggering events recorded in the ReWire System log during therapy sessions. The system will be considered feasible if \>50% of valid trigger attempts result in successful stimulation delivery.
次要结局
- 6 Meter Walk Test (6MWT)(At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.)
- 10 Meter Walk Test (10MWT)(At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.)
- Timed Up-and Go (TUG)Test(At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.)
- Walking Index for Spinal Cord Injury II (WISCI II)(At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.)
- Lower Extremity Motor Score (LEMS)(At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.)
- SCI-Functional Independence Scale - Ambulation Subsection (SCI-FIS)(At baseline (screening), after implantation, week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).)
- SCI Independence Measure (SCIM) III(At baseline (screening), after implantation, week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).)
- International SCI Pain Basic Data Set(At baseline (screening), after implantation, week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).)
- Observed Functional Change Assessment (OFCA)(At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.)
- Participant Satisfaction Survey(At week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).)
- Participant Blinding Questionnaire(At week 14 (double-blind phase).)
- Therapist Blinding Questionnaire(At week 14 (double-blind phase).)
研究者
Dr. Seth Hays
Professor
The University of Texas at Dallas