NCT07225582 · Case Western Reserve University
Development of Optimal Sensory Feedback Strategies to Maximize Function After Tetraplegia
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Brain 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.
Primary outcome measures
Force matching success rate
Time frame: 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
Time frame: From enrollment to around two years after enrollment
Percentage of trials per block in which the correct object was identified
Discrimination threshold
Time frame: 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
Time frame: From enrollment to around two years after enrollment
Minimal mechanical stimulus, delivered by a tactor that the participant can reliably perceive
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Enrolled in the ReHAB clinical trial and received ReHAB system components via implantation surgery.
- Willingness and availability to follow the study protocol.
Exclusion criteria
- 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
Where
- Cleveland, Ohio
Collaborators
University Hospitals Cleveland Medical Center, Cleveland Clinic Lerner Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 19, 2026 · Source of record for eligibility and locations