Development of Optimal Sensory Feedback Strategies to Maximize Function After Tetraplegia: A Sub-study of the Reconnecting the Hand and Arm to the Brain (ReHAB) Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Force matching success rate
研究概览
简要总结
The goal of this clinical trial is to learn more about how stimulating the nerves involved in sensation (either in the limbs or in the brain) can be used to restore sensation in participants who have a spinal cord injury. Participants in this study will have already been enrolled in the "Reconnecting the Hand and Arm to the Brain (ReHAB)" study, and received small electrodes in a part of the brain that is involved in sensing touch and pressure in the hand. The ReHAB study participants will also have received electrodes around the nerves in their arm. In this clinical trial, participants will receive two types of electrical stimulation:
- Intracortical microstimulation (ICMS) which involves sending small electrical pulses to the part of the brain that processes sensation.
- Peripheral nerve stimulation (PNS) which involves sending small electrical pulses to the nerves in the arm that transmit sensations from the hand.
Researchers will try different patterns of stimulation for both ICMS and PNS and study how the participants perceive the sensations from the different stimulation patterns. The researchers will also study how combining ICMS and PNS affects the perceived sensations.
详细描述
The overall goal of this study is to compare the sensations that are perceived from intracortical microstimulation (ICMS) to those perceived from peripheral nerve stimulation (PNS), and also to perceived sensations from a combination of ICMS and PNS.
Preceding study
Participants for this study will be individuals with a high-level spinal cord injury who are already enrolled in the "Reconnecting the Hand and Arm to the Brain (ReHAB)" clinical trial (ID# NCT03898804). The ReHAB clinical trial involves receiving tiny electrode arrays in the brain and small electrodes around some of the nerves in the arm. The goal of the ReHAB clinical trial is to restore arm and hand movement and sensation in individuals with paralysis from a spinal cord injury.
Goals of this clinical trial
The purpose of the proposed study is to investigate the perception and functional impact of sensory neurostimulation in participants with tetraplegia. Investigators will develop and implement novel paradigms of ICMS applied to primary somatosensory cortex (S1) and PNS applied to upper extremity nerves through chronically-implanted cuff electrodes. Investigators will also develop and assess hybrid neurostimulation paradigms involving paired application of ICMS and PNS. For each paradigm, investigators will quantify the perceived sensation with classic psychophysical methods. Investigators will also implement the approach into closed-loop tasks in virtual reality controlled through decoded cortical signals recorded from intracortical microelectrode arrays. Finally, investigators will assess the impact of each stimulation paradigm on residual sensory function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in the ReHAB clinical trial and received ReHAB system components via implantation surgery.
- •Willingness and availability to follow the study protocol.
排除标准
- •Lack of function or operability of all implanted ReHAB system components
- •Severe pain or other chronic medical condition that would prevent the participant from completing study-related activities
研究组 & 干预措施
Intracortical microstimulation and peripheral nerve stimulation for people with tetraplegia
The purpose of the proposed study is to investigate the perception and functional impact of sensory neurostimulation in participants with tetraplegia. Investigators will develop and implement novel paradigms of intracortical microstimulation (ICMS) applied to primary somatosensory cortex (S1) and peripheral nerve stimulation (PNS) applied to upper extremity nerves through chronically-implanted cuff electrodes. Investigators will also develop and assess hybrid neurostimulation paradigms involving paired application of ICMS and PNS. For each paradigm, investigators will quantify the perceived sensation with classic psychophysical methods. Investigators will also implement the approach into closed-loop tasks in virtual reality controlled through decoded cortical signals recorded from intracortical microelectrode arrays. Finally, investigators will assess the impact of each stimulation paradigm on residual sensory function.
干预措施: Brain Computer Interface (BCI) - Functional Electrical Stimulation (FES) system (Device)
结局指标
主要结局
Force matching success rate
时间窗: From enrollment to around two years after enrollment
Percentage of force matching trials per block in which the target force was achieved before the time limit
Object discrimination accuracy
时间窗: From enrollment to around two years after enrollment
Percentage of trials per block in which the correct object was identified
Discrimination threshold
时间窗: From enrollment until around two years post-enrollment
Minimal change in stimulation that results in a reliably distinguishable change in perceived magnitude
Tactor detection threshold
时间窗: From enrollment to around two years after enrollment
Minimal mechanical stimulus, delivered by a tactor that the participant can reliably perceive
次要结局
- Posture matching success rate(From enrollment to around two years after enrollment)
- Sensory dynamic range(From enrollment until around two years post-enrollment)
- Projected field location(From enrollment until around two years post-enrollment)
- Sensation quality(From enrollment to around two years after enrollment)
- Naturalness rating(From enrollment until around two years post-enrollment)
- Tactor discrimination threshold(From enrollment to around two years after enrollment)
- Force matching time to target(From enrollment to around two years after enrollment)
研究者
Emily Graczyk
Assistant Professor, Biomedical Engineering
Case Western Reserve University