Feasibility of Trigeminal and Vagus Nerve Stimulation in Subjects With Chronic Upper Extremity Deficits After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change
研究概览
简要总结
This is a single-center, multiphase pilot study of 16 subjects with residual upper extremity deficits at least six months after a supratentorial ischemic or hemorrhagic stroke. The purpose of the study is to evaluate the clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the trigeminal and/or vagus nerves (nTVNS) using the NeuraStasis Stimulator System adjunctive to rehabilitation. Phase 1 consisted of 5 unblinded subjects receiving nTVNS to assess device usability and safety. Phase 2 used a Prospective Randomized Open, Blinded Endpoint (PROBE) design comparing nTVNS to sham stimulation in 11 subjects. The study will inform the design and implementation of a pivotal study.
详细描述
This pilot study proceeded in two phases: Phase I, an unblinded stage, and Phase II, a blinded stage comparing intervention and sham groups.
Phase I consisted of 5 subjects, unblinded, receiving nTVNS. This phase tested the usability of the device and de-risked the use of nTVNS during rehabilitation. Visits included consent and baseline evaluation, followed by 6 weeks of treatment consisting of upper extremity rehabilitation paired with nTVNS. Rehabilitation and treatment occurred at a cadence of 3 sessions per week. Primary endpoints was collected after 6 weeks.
Phase II consisted of a Prospective Randomized Open, Blinded Endpoint (PROBE) design with 11 subjects randomized to an intervention nTVNS group or a control sham stimulation group. Both groups received a stimulation tolerability assessment at the start of each session to support blinding for therapists and subjects. For the sham group, no stimulation was delivered during the priming or rehabilitation portions of the session. The same evaluations, sessions, and endpoints occurred as those in Phase 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of unilateral supratentorial ischemic, intracerebral hemorrhagic, subarachnoid hemorrhagic, or a heterogeneous lesion stroke that occurred at least 6 months but not more than 15 years prior to enrollment.
- •Age >30 years and <85 years.
- •Fugl-Meyer Assessment, Upper Limb (FMA-UE) baseline score of 10 to 56 (inclusive of 10 and 56).
- •Ability to communicate, understand, and provide appropriate consent. Subjects should be able to follow two-step commands.
- •Right- or left-sided weakness of the upper extremity.
排除标准
- •Participant with any implanted metallic device at or near the stimulation sites (forehead and ears).
- •Participant with an implanted or active stimulator (ex. Deep brain stimulator, pacemaker, vagus nerve stimulator, defibrillator)
- •Participant skin in the stimulation area has open wounds, skin eruptions, swollen, infected, or inflamed areas, or skin abnormalities that could be cancerous
- •Advanced cardiac, pulmonary, liver, kidney dysfunction or blood system disease
- •Participant has a fever or shows clinical signs concerning for an infectious disease
- •Other neurologic or musculoskeletal diseases that could interfere with the assessments of this study
- •Low heart rate (<60 bpm) from a cardiac conduction block or related etiology
- •Participant has a history of trigeminal neuralgia
- •Participant has a history of Bell's Palsy
- •History of cranial nerve neuropathy (including facial nerve injury), carotid surgery, vagotomy, or other surgical intervention on the vagus nerve
- •History of recurrent syncopal events
- •Known or newly-discovered aneurysm or arteriovenous malformation
- •Patients who have any terminal illness such that the patient would not be expected to survive more than 90 days
- •Botox injections 12 weeks prior to or during therapy
- •Participants who have had a craniectomy:
- •Without replacement of bone flap
- •With bone flap replaced < 6 months prior to initiation of study activities
研究组 & 干预措施
Paired nTVNS Stimulation
Non-invasive electrical stimulation of the trigeminal and vagus nerves will be delivered by the NeuraStasis Stimulator System. The non-invasive Stimulation Electrode is positioned on the head (forehead and in the ear). The operator controls the stimulation delivery through the accompanying Controller.
Rehabilitation sessions begin with a stimulation tolerability assessment where the dose of therapy is selected. A 15-minute priming stimulation is delivered next, followed by the standard of care rehabilitation over the remaining session. During this rehabilitation paired nTVNS is delivered with repetitive motions.
干预措施: NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation) (Device)
Sham Stimulation
For the active sham comparator group, the non-invasive Stimulation Electrode is positioned on the head (forehead and in the ear) as in the experimental group. The operator controls the stimulation delivery through the accompanying Controller.
Rehabilitation sessions begin with a stimulation tolerability assessment where the dose of therapy is selected. Following the tolerability assessment, the device delivers 0 mA stimulation during the priming period and rehabilitation.
干预措施: Upper Limb Rehabilitation (Other)
Paired nTVNS Stimulation
Non-invasive electrical stimulation of the trigeminal and vagus nerves will be delivered by the NeuraStasis Stimulator System. The non-invasive Stimulation Electrode is positioned on the head (forehead and in the ear). The operator controls the stimulation delivery through the accompanying Controller.
Rehabilitation sessions begin with a stimulation tolerability assessment where the dose of therapy is selected. A 15-minute priming stimulation is delivered next, followed by the standard of care rehabilitation over the remaining session. During this rehabilitation paired nTVNS is delivered with repetitive motions.
干预措施: Upper Limb Rehabilitation (Other)
Sham Stimulation
For the active sham comparator group, the non-invasive Stimulation Electrode is positioned on the head (forehead and in the ear) as in the experimental group. The operator controls the stimulation delivery through the accompanying Controller.
Rehabilitation sessions begin with a stimulation tolerability assessment where the dose of therapy is selected. Following the tolerability assessment, the device delivers 0 mA stimulation during the priming period and rehabilitation.
干预措施: Sham Stimulation (Other)
结局指标
主要结局
Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change
时间窗: Within 7 days of completing 6 weeks of rehabilitation
The Fugl-Meyer Assessment, Upper Limb (FMA-UE) will be analyzed for the difference in average change after 6 weeks of therapy compared to baseline. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment).
次要结局
- Action Research Arm Test (ARAT) Average Change(Within 7 days of completing 6 weeks of rehabilitation)
- Proportion of subjects completing all pre-specified treatment doses(Upon completion of 6 weeks of rehabilitation)
- Subject Questionnaire on Device Usage(Upon completion of 6 weeks of rehabilitation)
- Therapist Questionnaire on Device Usage(Upon completion of 6 weeks of rehabilitation)
- Serious adverse device effects (SADE) rate at 24 hours post-therapy session(Up to 24 hours after each therapy session and ending 24 hours post-last therapy session at 6 weeks of rehabilitation)
- Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response %(Within 7 days of completing 6 weeks of rehabilitation)
- Stroke impact scale (SIS) Summative Score Average Change(Within 7 days of completing 6 weeks of rehabilitation)
- Analysis of the number of stimulations per therapy session(Upon completion of 6 weeks of rehabilitation)