Development of Optimal Sensory Feedback Strategies to Maximize Function After Tetraplegia
NCT ID: NCT07225582
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
3 participants
INTERVENTIONAL
2025-11-07
2030-09-01
Brief Summary
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* 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
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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).
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Intracortical microstimulation and peripheral nerve stimulation for people with tetraplegia
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Willingness and availability to follow the study protocol.
Exclusion Criteria
2. Severe pain or other chronic medical condition that would prevent the participant from completing study-related activities
22 Years
65 Years
ALL
No
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Cleveland Clinic Lerner Research Institute
UNKNOWN
Case Western Reserve University
OTHER
Responsible Party
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Emily Graczyk
Assistant Professor, Biomedical Engineering
Principal Investigators
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Emily Graczyk, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Locations
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Case Western Reserve University
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Emily Graczyk, Ph.D.
Role: primary
Related Links
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This website provides information about the ReHAB Study.
Other Identifiers
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STUDY20190226
Identifier Type: -
Identifier Source: org_study_id