Development of Optimal Sensory Feedback Strategies to Maximize Function After Tetraplegia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorCase Western Reserve University
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Brain Computer Interface (BCI) - Functional Electrical Stimulation (FES) system
DeviceParticipants 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.
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: Intracortical microstimulation and peripheral nerve stimulation for people with tetraplegiaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Force matching success rate
Percentage of force matching trials per block in which the target force was achieved before the time limit
Time frame
From enrollment to around two years after enrollment2
Object discrimination accuracy
Percentage of trials per block in which the correct object was identified
Time frame
From enrollment to around two years after enrollment3
Discrimination threshold
Minimal change in stimulation that results in a reliably distinguishable change in perceived magnitude
Time frame
From enrollment until around two years post-enrollment4
Tactor detection threshold
Minimal mechanical stimulus, delivered by a tactor that the participant can reliably perceive
Time frame
From enrollment to around two years after enrollmentSecondary outcomes
1
Sensory dynamic range
Difference in minimum and maximum stimulation levels that elicit detectable, comfortable sensation
Time frame
From enrollment until around two years post-enrollment2
Projected field location
The position of the sensory percept reported on a hand/arm diagram
Time frame
From enrollment until around two years post-enrollment3
Sensation quality
The participant's description of the quality of the sensation evoked by stimulation, reported as a selection of descriptor words
Time frame
From enrollment to around two years after enrollment4
Naturalness rating
The participant's rating of the perceived naturalness of the stimulus on an open-ended scale
Time frame
From enrollment until around two years post-enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov