Spinal Cord Injury CervicalNCT07225582
Development of Optimal Sensory Feedback Strategies to Maximize Function After Tetraplegia
A study testing Brain Computer Interface (BCI) - Functional Electrical Stimulation (FES) system in people with Spinal Cord Injury Cervical and Spinal Cord Injuries (Complete and Incomplete), run by Case Western Reserve University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Spinal Cord Injury Cervical, Spinal Cord Injuries (Complete and Incomplete)
- What is being tested?
- Brain Computer Interface (BCI) - Functional Electrical Stimulation (FES) system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2026to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in the ReHAB clinical trial and received ReHAB system components via implantation surgery.
- Willingness and availability to follow the study protocol.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Emily Graczyk, Ph.D., 216-368-5182, emily.graczyk@case.edu
Emily Graczyk, Ph.D.
About this study
Official title: 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
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.
Read the detailed 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 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.
In Aim 1, investigators will develop a novel ICMS paradigm that attempts to reproduce both the temporal and spatial activation patterns that occur in S1 during normal touch. Investigators will compare this novel paradigm to other existing ICMS encoders. Investigators will assess the impact of each ICMS encoder on perceptual response, task performance in virtual reality (VR), and residual sensory function. In Aim 2, investigators will develop novel PNS paradigms and assess the efficacy of PNS for sensory feedback in people with tetraplegia for the first time. As in Aim 1, investigators will develop and compare several PNS encoders, including those that reproduce aspects of the peripheral response to normal touch and traditional linear encoders. We will assess the impact of each PNS encoder on perceptual response, task performance in VR, and residual sensory function. In Aim 3, we will develop hybrid neurostimulation paradigms that pair ICMS with PNS. We will assess the impact of stimulation encoder and stimulation amplitude on the perceived sensations generated by hybrid stimulation. We will then investigate the impact of PNS-ICMS timing delays within the hybrid neurostimulation paradigm on the perceptual response, functional impact, and impact on residual sensory function.
All participants will participate in all aims and will receive all stimulation approaches and perform all tasks and measures. All participants will serve as their own control for the planned statistical analyses. The study will generate tens of thousands of perceptual response data points, hundreds of functional task data points, and hundreds of thousands of intracortical recordings (for exploratory analyses).
- Being tested
- Brain Computer Interface (BCI) - Functional Electrical Stimulation (FES) system
- Keywords
- spinal cord injury, tetraplegia, intracortical microstimulation, peripheral nerve stimulation
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Computer Interface (BCI) - Functional Electrical Stimulation (FES) systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intracortical microstimulation and peripheral nerve stimulation for people with tetraplegia | Experimental | 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. Receives: Device: Brain Computer Interface (BCI) - Functional Electrical Stimulation (FES) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force matching success rate
Percentage of force matching trials per block in which the target force was achieved before the time limit
Measured: From enrollment to around two years after enrollment
Object discrimination accuracy
Percentage of trials per block in which the correct object was identified
Measured: From enrollment to around two years after enrollment
Discrimination threshold
Minimal change in stimulation that results in a reliably distinguishable change in perceived magnitude
Measured: From enrollment until around two years post-enrollment
Tactor detection threshold
Minimal mechanical stimulus, delivered by a tactor that the participant can reliably perceive
Measured: From enrollment to around two years after enrollment
Secondary outcomes (7)
Sensory dynamic range
Difference in minimum and maximum stimulation levels that elicit detectable, comfortable sensation
Measured: From enrollment until around two years post-enrollment
Projected field location
The position of the sensory percept reported on a hand/arm diagram
Measured: From enrollment until around two years post-enrollment
Sensation quality
The participant's description of the quality of the sensation evoked by stimulation, reported as a selection of descriptor words
Measured: From enrollment to around two years after enrollment
Naturalness rating
The participant's rating of the perceived naturalness of the stimulus on an open-ended scale
Measured: From enrollment until around two years post-enrollment
Tactor discrimination threshold
Minimal change in mechanical touch input that results in a reliably distinguishable change in perceived magnitude
Measured: From enrollment to around two years after enrollment
Force matching time to target
The time elapsed from the go cue required for the participant to hit the force target
Measured: From enrollment to around two years after enrollment
Posture matching success rate
Percentage of posture matching trials per block in which the target posture was achieved before the time limit
Measured: From enrollment to around two years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study start13 Jan 2026
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury CervicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center, Cleveland Clinic Lerner Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Emily Graczyk, Case Western Reserve University
- Investigators
- Emily Graczyk, Ph.D., Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225582
- Sponsor's protocol ID
- STUDY20190226
- Other IDs
- R01HD117313
- Status last verified
- Feb 2026
- First submitted
- 4 Nov 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD may be shared for publications.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07225582
- Acronym / sponsor ID
- STUDY20190226
- Keywords
- spinal cord injury, tetraplegia, intracortical microstimulation, peripheral nerve stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center, Cleveland Clinic Lerner Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 6 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
In Aim 1, investigators will develop a novel ICMS paradigm that attempts to reproduce both the temporal and spatial activation patterns that occur in S1 during normal touch. Investigators will compare this novel paradigm to other existing ICMS encoders. Investigators will assess the impact of each ICMS encoder on perceptual response, task performance in virtual reality (VR), and residual sensory function. In Aim 2, investigators will develop novel PNS paradigms and assess the efficacy of PNS for sensory feedback in people with tetraplegia for the first time. As in Aim 1, investigators will develop and compare several PNS encoders, including those that reproduce aspects of the peripheral response to normal touch and traditional linear encoders. We will assess the impact of each PNS encoder on perceptual response, task performance in VR, and residual sensory function. In Aim 3, we will develop hybrid neurostimulation paradigms that pair ICMS with PNS. We will assess the impact of stimulation encoder and stimulation amplitude on the perceived sensations generated by hybrid stimulation. We will then investigate the impact of PNS-ICMS timing delays within the hybrid neurostimulation paradigm on the perceptual response, functional impact, and impact on residual sensory function.
All participants will participate in all aims and will receive all stimulation approaches and perform all tasks and measures. All participants will serve as their own control for the planned statistical analyses. The study will generate tens of thousands of perceptual response data points, hundreds of functional task data points, and hundreds of thousands of intracortical recordings (for exploratory analyses).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracortical microstimulation and peripheral nerve stimulation for people with tetraplegia | Experimental | Device: Brain Computer Interface (BCI) - Functional Electrical Stimulation (FES) systemThe 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. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Enrolled in the ReHAB clinical trial and received ReHAB system components via implantation surgery.
- Willingness and availability to follow the study protocol.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Computer Interface (BCI) - Functional Electrical Stimulation (FES) systemParticipants 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. | Device | Intracortical microstimulation and peripheral nerve stimulation for people with tetraplegia |
Primary outcome
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
7 secondary outcomes
Sensory dynamic range
Time frame: From enrollment until around two years post-enrollment
Projected field location
Time frame: From enrollment until around two years post-enrollment
Sensation quality
Time frame: From enrollment to around two years after enrollment
Naturalness rating
Time frame: From enrollment until around two years post-enrollment
Tactor discrimination threshold
Time frame: From enrollment to around two years after enrollment
Force matching time to target
Time frame: From enrollment to around two years after enrollment
Posture matching success rate
Time frame: From enrollment to around two years after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- This website provides information about the ReHAB Study.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD may be shared for publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Graczyk, Ph.D. principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Computer Interface (BCI) - Functional Electrical Stimulation (FES) system in people with Spinal Cord Injury Cervical and Spinal Cord Injuries (Complete and Incomplete), run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Graczyk, Ph.D. (216.368.5182, elg46@case.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Force matching success rate (time frame: From enrollment to around two years after enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.