Safety and Feasibility of Paired taVNS With Upper Limb Rehabilitation in Incomplete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Feasibility as assessed by the participants' perceptions of the usefulness of the intervention
研究概览
简要总结
The purpose of this study is to evaluate the safety and feasibility of transcutaneous auricular Vagus Nerve Stimulation (taVNS) paired with upper-limb rehabilitation in adults with tetraplegia caused by cervical spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of traumatic incomplete (AIS B-D) cervical spinal cord injury (C8 and above)
- •at least 12 months post-traumatic SCI but less than 10 years post-SCI
- •demonstrate some residual movement in the upper limb (e.g., able to perform pinch movement with thumb and index finger sufficient to grip small objects such as marble)
排除标准
- •non-traumatic SCI
- •recent ear trauma and skin lesions at the site of stimulation, such as sunburn, cuts, and open sores,
- •facial or ear pain,
- •allergic reaction to adhesives and electrodes,
- •any current or past history of cardiovascular disorders,
- •intracranial metal implants, pacemakers,
- •concomitant clinically significant brain injury,
- •receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry
- •If there is a plan for alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
- •medical or mental instability;
- •pregnancy or plans to become pregnant during the study period
研究组 & 干预措施
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
干预措施: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) (Device)
结局指标
主要结局
Feasibility as assessed by the participants' perceptions of the usefulness of the intervention
时间窗: from baseline through completion of 18 sessions (about 6-8 weeks)
This is numerically rated from ''not at all useful' at 0 and 'very useful' at 10 , higher score indicating better outcome
Safety as assessed by number of subjects with change in systolic blood pressure
时间窗: Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with change in diastolic blood pressure
时间窗: Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with change in heart rate
时间窗: Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with change in respiratory rate
时间窗: Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with change in autonomic dysreflexia
时间窗: Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with worsening spasticity
时间窗: Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with change in pain at stimulation site
时间窗: Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of adverse events that occurred during the study period
时间窗: post therapy 30 days
Feasibility as assessed by the number of treatment sessions attended by each participant . The intervention is considered feasible if at least 80% adherence rate is achieved and no serious adverse events occurred.
时间窗: from baseline through completion of 18 sessions (about 6-8 weeks)
80% adherence rate is defined as completing ≥ 16 out of 18 sessions
Feasibility as assessed by the participants' perceptions of the study procedures
时间窗: from baseline through completion of 18 sessions (about 6-8 weeks)
This includes implementation using the paired taVNS with rehabilitation. This is numerically rated from 'not difficult at all' at 0, and 'very difficult' at 10, higher score indicating worse outcome
次要结局
- Change in degree of upper limb impairment as assessed by the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assessment(Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days])
- Change in hand function as assessed by the Toronto Rehab Institute Hand Function Test (TRI-HFT)(Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days])
- Change in capability of using arms and hands as assessed by the Capabilities of Upper Extremity Questionnaire (CUE-Q)(Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days])
- Change in self care independence as assessed by the Spinal Cord Injury Independence Measure-III (SCIM-III) self-care subscore(Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days])
- Change in Quality of Life as assessed by the Spinal Cord Injury- Quality of Life (SCI-QoL) questionnaire(Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days])
- Change in Pain as assessed by the International SCI pain basic data subset (version 2)(Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days])
- Change in Depression as assessed by the Patient Health Questionnaire (PHQ-8)(Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days])
研究者
Radha Korupolu
Associate Professor
The University of Texas Health Science Center, Houston