Movement-Associated tVNS and Responsiveness Testing for Personalized Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Pupil size change
研究概览
简要总结
The goal of this study is to learn about the acute pupil response to transcutaneous vagus nerve stimulation (tVNS) in stroke survivors and healthy adults. The main question it aims to answer is whether pupil size response is greater with bilateral tVNS compared to unilateral tVNS. Participants will receive tVNS and sham at the outer ear unilaterally and bilaterally in resting condition. The pupil size of the participants will be recorded during tVNS.
详细描述
Participants will wear surface electrodes on the outer ear on both sides and a finger device that monitors heart rate. The attachment sites are the tragus or the cymba concha (depending on the shape and size of the ear) for tVNS and the ear lobe for sham. The electrical current will have a pulse duration of 0.1 ms at 30 Hz with an intensity below the pain threshold or 5 milliamp, whichever is lower, for a duration of 0.5 s. The experimental stimulation intensity will be determined as just below the pain threshold. Participants will receive multiple blocks of unilateral left, unilateral right, and bilateral stimulations to the sham or tVNS electrodes at rest, during which their pupil size will be recorded. The order of unilateral/bilateral and sham/tVNS stimulation will be randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None (Participant, Outcomes Assessor)
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
- 是
入选标准
- •18-89 years old across all races, genders, and ethnicities.
- •Post-stroke subjects will have persistent hemiparesis on the upper extremity (UE) with some residual UE voluntary movement.
排除标准
- •Able-bodied subjects:
- •Younger than 18 years old or older than 89 years old
- •Current or history of cardiac disease
- •Have a vision problem not corrected by glasses or contact lenses
- •Have an implanted device such as a neurostimulator or cochlear implant
- •Current or history of tympanic membrane perforation
- •Had a stroke or lesion (including tumor) in your brain
- •Had a head injury or brain surgery
- •Suffer from frequent or severe headaches
- •Had a fainting spell or syncope
- •Have any metal in the head such as shrapnel, surgical clips, or fragments from welding or metal work
- •Have any implanted device such as cardiac pacemakers, medical pumps, or intra-cardiac lines
- •Had any brain-related conditions (i.e. multiple sclerosis, Parkinson, Alzheimer)
- •Had any illness that caused brain injury (i.e. meningitis, aneurysm, brain tumor)
- •Had any head trauma that was associated with a loss of consciousness or diagnosed as a concussion
- •Being treated for any psychiatric condition (i.e. depression, anxiety, PTSD, schizophrenia)
- •Suspected of pregnancy
- •Post-stroke subjects:
- •Younger than 18 years old or older than 89 years old
- •Current or history of cardiac disease
- •Have a vision problem not corrected by glasses or contact lenses
- •Have any implanted devices such as a neurostimulator or cochlear implant
- •Current or history of tympanic membrane perforation
- •No persistent hemiparesis on the upper extremity (UE)
- •No residual UE voluntary movement
- •A first stroke less than 4 months prior to the participation
- •Serious uncontrolled medical conditions
- •Excessive pain in any joint of the more affected extremity
- •Unable to stand independently for 2 min., transfer independently to and from the toilet or perform sit-to-stand
- •Suffer from frequent or severe headaches
- •Had a fainting spell or syncope
- •Have any metal in the head such as shrapnel, surgical clips, or fragments from welding or metal work
- •Have any implanted device such as cardiac pacemakers, medical pumps, or intra-cardiac lines
- •Had any illness that caused brain injury (i.e. meningitis, aneurysm, brain tumor)
- •Had any head trauma that was associated with a loss of consciousness or diagnosed as a concussion
- •Being treated for any psychiatric condition (i.e. depression, anxiety, PTSD, schizophrenia)
- •Suspected of pregnancy
- •A score of less than 24 on the Folstein Mini-Mental State Examination
- •Excessive frailty or lack of stamina (e.g., cannot attend to instructions, stay awake, engage in functional activities, etc.)
- •Excessive pain in any joint of the more affected extremity that could limit ability to cooperate with the intervention
研究组 & 干预措施
Repeated-Measures Stimulation Protocol
All participants receive all six stimulation conditions: unilateral left sham, unilateral right sham, bilateral sham, unilateral left transcutaneous vagus nerve stimulation (tVNS), unilateral right tVNS, and bilateral tVNS. Each participant completes 12 blocks during a single testing session, with each block containing one trial of each of the six stimulation conditions. Twelve blocks with different predefined orders of the six conditions were established before testing began. For each participant, the order of the 12 predefined blocks is randomized. Thus, each participant receives each of the six stimulation conditions once per block and 12 times in total.
干预措施: Unilateral Left tVNS stimulation (Procedure)
Repeated-Measures Stimulation Protocol
All participants receive all six stimulation conditions: unilateral left sham, unilateral right sham, bilateral sham, unilateral left transcutaneous vagus nerve stimulation (tVNS), unilateral right tVNS, and bilateral tVNS. Each participant completes 12 blocks during a single testing session, with each block containing one trial of each of the six stimulation conditions. Twelve blocks with different predefined orders of the six conditions were established before testing began. For each participant, the order of the 12 predefined blocks is randomized. Thus, each participant receives each of the six stimulation conditions once per block and 12 times in total.
干预措施: Bilateral tVNS stimulation (Procedure)
Repeated-Measures Stimulation Protocol
All participants receive all six stimulation conditions: unilateral left sham, unilateral right sham, bilateral sham, unilateral left transcutaneous vagus nerve stimulation (tVNS), unilateral right tVNS, and bilateral tVNS. Each participant completes 12 blocks during a single testing session, with each block containing one trial of each of the six stimulation conditions. Twelve blocks with different predefined orders of the six conditions were established before testing began. For each participant, the order of the 12 predefined blocks is randomized. Thus, each participant receives each of the six stimulation conditions once per block and 12 times in total.
干预措施: Unilateral Left Sham stimulation (Procedure)
Repeated-Measures Stimulation Protocol
All participants receive all six stimulation conditions: unilateral left sham, unilateral right sham, bilateral sham, unilateral left transcutaneous vagus nerve stimulation (tVNS), unilateral right tVNS, and bilateral tVNS. Each participant completes 12 blocks during a single testing session, with each block containing one trial of each of the six stimulation conditions. Twelve blocks with different predefined orders of the six conditions were established before testing began. For each participant, the order of the 12 predefined blocks is randomized. Thus, each participant receives each of the six stimulation conditions once per block and 12 times in total.
干预措施: Bilateral Sham stimulation (Procedure)
Repeated-Measures Stimulation Protocol
All participants receive all six stimulation conditions: unilateral left sham, unilateral right sham, bilateral sham, unilateral left transcutaneous vagus nerve stimulation (tVNS), unilateral right tVNS, and bilateral tVNS. Each participant completes 12 blocks during a single testing session, with each block containing one trial of each of the six stimulation conditions. Twelve blocks with different predefined orders of the six conditions were established before testing began. For each participant, the order of the 12 predefined blocks is randomized. Thus, each participant receives each of the six stimulation conditions once per block and 12 times in total.
干预措施: Unilateral Right tVNS stimulation (Procedure)
Repeated-Measures Stimulation Protocol
All participants receive all six stimulation conditions: unilateral left sham, unilateral right sham, bilateral sham, unilateral left transcutaneous vagus nerve stimulation (tVNS), unilateral right tVNS, and bilateral tVNS. Each participant completes 12 blocks during a single testing session, with each block containing one trial of each of the six stimulation conditions. Twelve blocks with different predefined orders of the six conditions were established before testing began. For each participant, the order of the 12 predefined blocks is randomized. Thus, each participant receives each of the six stimulation conditions once per block and 12 times in total.
干预措施: Unilateral Right Sham stimulation (Procedure)
结局指标
主要结局
Pupil size change
时间窗: Day 1
Acute change in pupil size in response to electrical stimulation, relatively expressed as a percent change from the baseline
Peak Percent Change in Pupil Diameter During Stimulation
时间窗: During one study visit (within 1 day)
For each stimulation trial, pupil diameter is recorded continuously. The outcome is the maximum percent change in pupil diameter during the stimulation period relative to the mean pupil diameter measured immediately before stimulation within the same trial.
Mean Percent Change in Pupil Diameter During Stimulation
时间窗: During one study visit (within 1 day)
For each stimulation trial, pupil diameter is recorded continuously. The outcome is the mean percent change in pupil diameter during the stimulation period relative to the mean pupil diameter measured immediately before stimulation within the same trial.
次要结局
未报告次要终点