About this trial
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.
Eligibility criteria
Qualifiers
Enrolled in the ReHAB clinical trial and received ReHAB system components via implantation surgery.
Willingness and availability to follow the study protocol.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Brain Computer Interface (BCI) - Functional Electrical Stimulation (FES) system
Treatment groups
Sponsors and collaborators
Case Western Reserve University
Lead sponsor
University Hospitals Cleveland Medical Center
Collaborator
Cleveland Clinic Lerner Research Institute
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator