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
Case Western Reserve University
Summary
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.
Description
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 i…
Eligibility
- Age range
- 22–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Enrolled in the ReHAB clinical trial and received ReHAB system components via implantation surgery. 2. Willingness and availability to follow the study protocol. Exclusion Criteria: 1. Lack of function or operability of all implanted ReHAB system components 2. Severe pain or other chronic medical condition that would prevent the participant from completing study-related activities
Interventions
- DeviceBrain Computer Interface (BCI) - Functional Electrical Stimulation (FES) system
Participants with tetraplegia who have received intracortical arrays in the sensory cortex and peripheral nerve cuff electrodes will undergo a variety of stimulation paradigms to investigate the perception and functional impact of sensory neurostimulation.
Location
- Case Western Reserve UniversityCleveland, Ohio