Vagus Nerve Stimulation (VNS) in Spinal Cord Injury (SCI) Adaptive Follow-On Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Incidence of adverse events (device safety)
研究概览
简要总结
This study is an open label extension of the SCI EFS clinical trial (NCT04288245) that developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury. The objectives of this study are to provide continued safety assessment for the investigational ReStore system, and to gain further estimate of the effect of Vagus Nerve Stimulation (VNS) with rehabilitative exercises in four different tracks - upper limb (UL), lower limb (LL), bladder control (BC), and sensory (SY) for participants with chronic SCI (Spinal Cord Injury).
详细描述
A prospective, multi-center, non-randomized, open label extension of the SCI EFS trial (NCT04288245) participants implanted with the investigational ReStore Device for VNS Therapy. Following the completion of Phase 2 of the SCI EFS study, participants can enroll to one of the four tracks. Under each track, participants will undergo up to 36 sessions of rehabilitative exercises self-paced by participants with targeted completion of 3 sessions per week. Evaluations will be administered at the beginning and end of each track (additional progress checks may be conducted, as required by the staff) to monitor participant progress. Upon completion of a track, participants can choose to re-enroll in the same or a different track. Adverse events will be documented and assessed throughout the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria:
- •Completed phase 2 of the SCI EFS study (NCT04288245)
- •Willing to comply with procedures for the entire duration of the study (study protocol compliance)
- •Provision of signed and dated informed consent form
- •Access to reliable communication and internet connections (for those intending to complete sessions at home)
- •Has not had their VNS device explanted
排除标准
- •Concurrent participation in another active interventional trial or participation in an active interventional trial within 7 days prior to enrollment
- •Any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator
- •Any condition which would preclude adequate evaluation of device's safety and performance in the judgment of the Investigator
- •Individuals who have a change in medical condition or health status such that they would meet the exclusion criteria of the EFS
- •Concomitant clinically significant brain injuries
- •Receiving any other therapy that would interfere with VNS
- •Females of childbearing potential who are either pregnant, lactating, heterosexually active, or planning to become pregnant or heterosexually active during study participation; and who are not using, or will not agree to use medically acceptable birth control methods
- •Psychiatric disorders, psychosocial, and/or cognitive impairment that would interfere with study participation, as assessed by medical evaluation
- •Participants with a current or past: (i) medical (psychiatric, non-psychiatric) condition, disease, disorder, injury, or disability; or (ii) non-medical situation or circumstance that, in the opinion of the principal investigator, 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
- •Participants with active neoplastic disease.
- •Participants with significant local circulatory problems, (e.g. thrombophlebitis and lymphedema, and clinically-significant hypotension or bradycardia).
- •Participants with any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator.
- •Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
- •Aphasia and other cognitive deficits may be present but participants will be excluded if are unable to understand the potential risks and benefits of the study or personally provide informed consent.
- •A recent history of syncope
- •A recent history of dysphagia
- •Currently require, or are likely to require diathermy
- •Significant respiratory issues that would interfere with participation
- •Non-English speaking
- •Patients who are acutely suicidal and/or have been admitted for a suicide attempt
- •As determined by the principal investigator, is under current incarceration or legal detention
- •Track Specific Inclusion Criteria:
- •Upper Limb (UL):
- •Lower Limb (LL):
- •Ambulatory with gait impairment
- •Bladder Control (BC):
- •Issues with urinary function arising from SCI, with partial voluntary initiation of voiding 2)Intermittent catheterization for bladder management
- •Sensory (SY):
- •Impairment in sensory function, based on the baseline assessments below:
- •US-NSA score <92 points
- •Two-point discrimination fingertip score >5mm
- •Two-point discrimination palm score >15mm
- •Tactile Discrimination Test score <16points
- •Semmes-Weinstein Monofilaments score >3.61g
- •Track Specific Exclusion Criteria:
- •Upper Limb (UL):
- •Lower Limb (LL):
- •Bladder Control (BC):
- •Indwelling catheter use 2)Participants with a history of severe or recurrent autonomic dysreflexia 3)Technical limitations that would preclude bladder ultrasonography assessments 4)Medical history that would preclude adequate evaluation of urologic outcomes
- •Sensory (SY):
- •Pain that would impede study participation
研究组 & 干预措施
Upper limb (UL)
Participants in this arm will receive up to 36 sessions of VNS paired with upper limb rehabilitative exercises
干预措施: Active VNS (Device)
Lower limb (LL)
Participants in this arm will receive up to 36 sessions of VNS paired with lower limb rehabilitative exercises
干预措施: Active VNS (Device)
Bladder control (BC)
Participants in this arm will receive up to 36 sessions of VNS paired with bladder control rehabilitative exercises
干预措施: Active VNS (Device)
Sensory (SY)
Participants in this arm will receive up to 36 sessions of VNS paired with sensory rehabilitative exercises
干预措施: Active VNS (Device)
结局指标
主要结局
Incidence of adverse events (device safety)
时间窗: Starting at session 1 on week 1, throughout the study up to last session 36 on week 15.
UL, LL, BC and SY - Review of adverse events reported throughout the trial will be used to inform the potential risks associated with the ReStore System
次要结局
- Postvoid residual volume (PVR)(At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.)
- Urinary Distress Inventory (UDI-6), short form questionnaire(At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.)
- Jebsen-Taylor Hand Function (JTHF) Score(At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.)
- Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)(At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.)
- Force & Range of motion(At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.)
- 6 Meter Walk Test (6MWT)(At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.)
- 10 Meter Walk Test (10MWT)(At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.)
- Walking Index for Spinal Cord Injury II (WISCI II)(At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.)
- Berg's Balance Scale (BBG)(At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.)
- Timed Up-and Go (TUG)Test(At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.)
- Lower Extremity Motor Score (LEMS)(At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.)
- Voiding efficiency(At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.)
- Bladder volume capacity(At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.)
- Neurogenic Bladder Symptom Score (NBSS) questionnaire(At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.)
- Two - Point Discrimination(At session 1 on week 1, on week 8, week 12 and as needed during intervening sessions from week 2 to 7.)
- Tactile Discrimination Test (TDT)(At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7.)
- Semmes-Weinstein Monofilaments (SWM)(At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7.)
- US-Nottingham Sensory Assessment (US-NSA)(At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7.)
- International SCI Pain Basic Data(At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7.)
研究者
Dr. Seth Hays
Professor
The University of Texas at Dallas