Vagus Nerve Stimulation to Promote Remyelination in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change from baseline in time to complete the grooved peg test
研究概览
简要总结
The goal of this clinical trial is to learn if stimulating the vagus nerve in combination with a motor task in people with multiple sclerosis can improve motor function. The main questions it aims to answer are:
- Is stimulating the vagus nerve safe and feasible after demyelinating episodes?
- Does a paired motor task with vagus nerve stimulation improve motor function with someone who has multiple sclerosis?
Researchers will compare active vagus nerve stimulation to a sham stimulation to see if the paired vagus nerve stimulation can improve motor control.
Participants will:
- Come in for study visits over a six month period. Study visits are three times weekly for the first month, then single follow up visits at two, three, and six months.
- During study visits, participants will complete 30 minutes of the paired vagus nerve stimulation with a motor task, specifically the grooved peg test.
- At various timepoints throughout the study, motor, disability, and neurophysiological assessments will be administered, including the Timed 25-Foot Walk Test, Expanded Disability Status Scale (EDSS), Upper Extremity portion of the Fugl-Meyer Assessment, Dellon-Modified Moberg Pick-Up Test, Multiple Sclerosis Impact Scale-29 (MSIS-29), motor evoked potentials (MEPs), and visual evoked potentials (VEPs). MRI assessments will also be performed to evaluate exploratory imaging metrics of potential remyelinative efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants ages 18-70 with diagnosis of multiple sclerosis at least 30 days from last relapse
- •Baseline grooved peg test time greater than or equal to 91 seconds for completion of the task (2 standard deviation above mean multiple sclerosis score).
- •Ability to sign informed consent
- •Expanded disability status scale score (or estimated) of 2.5 or greater OR a clinical report of upper extremity dysfunction in their dominant hand
排除标准
- •Current uncontrolled and/or clinically significant medical condition.
- •History of seizures or epilepsy.
- •Other central nervous system disease or significant brain trauma.
- •Bacterial or viral infection within the prior 30 days.
- •Prior treatment with total body irradiation, clemastine, bexarotene, or other experimental remyelinating agent.
- •Recent suicide attempt or continued expressed suicidal ideation.
- •Implanted devices, such as pacemakers, cochlear prosthesis, neuro-stimulators.
- •Abnormal ear anatomy or ear infection.
- •Pregnancy, lactation, or lack of use of contraception.
- •Unable to walk 25 feet continuously
- •Other significant disease or disorder that might impair study participation. Participants will be allowed to initiate or maintain background disease modifying therapy to reduce the risk of multiple sclerosis relapse and optimize recruitment.
研究组 & 干预措施
Experimental - Active Stimulation
Participants in this arm will receive active stimulation during the paired motor task.
干预措施: Closed Loop Trans-Auricular Vagus Nerve Stimulation System (Device)
Control - Sham Stimulation
Participants in this arm will receive sham stimulation during the paired motor task to create a control to the experimental group.
干预措施: Placebo (Device)
结局指标
主要结局
Change from baseline in time to complete the grooved peg test
时间窗: End of Study (6 months)
The participant will complete the grooved peg test with their dominant hand and will be timed while doing so. The change in time to completion will be tracked over the study.
Change from baseline of score of the upper extremity portion of the Fugl-Meyer Assessment
时间窗: End of Study (6 months)
The upper extremity portion of the Fugl-Meyer assessment evaluates movements of the upper limbs with score ranging from 0 - 66. A higher score indicates more function.
Change from baseline score of the Expanded Disability Status Scale
时间窗: End of Study (6 months)
The expanded disability status scale scores range from 0 - 10, where 10 indicates full function.
Change in time from baseline to complete the timed 25 foot walk test
时间窗: End of Study (6 months)
The timed 25 foot walk test is a performance measure where the participants walks 25 feet unassisted and the time to completion is recorded.
Change from baseline in composite disability metric
时间窗: End of Study (6 months)
The fraction of participants in each intervention group at 6 months with improvement in disability will be determined by a composite disability metric composed of three elements: expanded disability status scale, timed 25 foot walk, and grooved peg test time. The metric will be deemed positive if there is a significant change in one or more of the measures as determined as follows: 1) decrease in expanded disability status scale score of 1 point (baseline expanded disability status scale score ≤5.5) or 0.5 point (baseline expanded disability status scale score of \>5.5); 2) 20% decrease in timed 25 foot walk test; or 3) 25% decrease in grooved peg test time. The composite disability metric will be quantified by a trained study personnel.
Change from baseline in patient reported outcomes from the multiple sclerosis impact scale 29
时间窗: End of Study (6 months)
The Multiple Sclerosis Impact Scale - 29 is a 29-item patient-reported measure of the physical and psychological impacts of multiple sclerosis. Participants are asked to rate how much their functioning and well-being has been impacted over the past 14 days on a 4-point scale. Higher scores indicate a greater disease impact.
Frequency of adverse events in response to paired-taVNS treatment
时间窗: End of Study (6 months)
The frequency of adverse events (AEs) or serious adverse events (SAEs) will be monitored during the 6-month paired-taVNS treatment to measure the safety and tolerance of the intervention.
次要结局
- Change from baseline in time to complete the grooved peg test(End of Study (6 months))
- Change from baseline of score of the upper extremity portion of the Fugl-Meyer Assessment(End of Study (6 months))
- Change from baseline score of the Expanded Disability Status Scale(End of Study (6 months))
- Change in time from baseline to complete the timed 25 foot walk test(End of Study (6 months))
- Change from baseline in composite disability metric(End of Study (6 months))
- Change in Dellon-Modified Moberg Pick-Up Test(End of Study (6 months))
- Change from baseline in patient reported outcomes from the multiple sclerosis impact scale 29(End of Study (6 months))
- Motor Evoked Potential(End of Study (6 months))
- Visual Evoked Potential(End of Study (6 months))