Development of Optimal Sensory Feedback Strategies to Maximize Function After Tetraplegia

NCT07225582 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY20190226R01HD117313
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spinal Cord Injury Cervical; Spinal Cord Injuries (Complete and Incomplete)

Keywords

spinal cord injury; tetraplegia; intracortical microstimulation; peripheral nerve stimulation

Outcome Measures

Primary Outcomes (4)

• Force matching success rate

  Percentage of force matching trials per block in which the target force was achieved before the time limit

  From enrollment to around two years after enrollment

• Object discrimination accuracy

  Percentage of trials per block in which the correct object was identified

  From enrollment to around two years after enrollment

• Discrimination threshold

  Minimal change in stimulation that results in a reliably distinguishable change in perceived magnitude

  From enrollment until around two years post-enrollment

• Tactor detection threshold

  Minimal mechanical stimulus, delivered by a tactor that the participant can reliably perceive

  From enrollment to around two years after enrollment

Secondary Outcomes (7)

• Sensory dynamic range

  From enrollment until around two years post-enrollment

• Projected field location

  From enrollment until around two years post-enrollment

• Sensation quality

  From enrollment to around two years after enrollment

• Naturalness rating

  From enrollment until around two years post-enrollment

• Tactor discrimination threshold

  From enrollment to around two years after enrollment

Study Arms (1)

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.

Device: Brain Computer Interface (BCI) - Functional Electrical Stimulation (FES) system

Interventions

Brain Computer Interface (BCI) - Functional Electrical Stimulation (FES) system DEVICE

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.

Intracortical microstimulation and peripheral nerve stimulation for people with tetraplegia

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled in the ReHAB clinical trial and received ReHAB system components via implantation surgery.
• Willingness and availability to follow the study protocol.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cleveland Clinic Lerner Research Institute: collaborator
• Case Western Reserve University: lead
• University Hospitals Cleveland Medical Center: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

Related Links

• This website provides information about the ReHAB Study.

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Interventions

Brain-Computer Interfaces; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies; Drug Therapy; Therapeutics

Study Officials

• Emily Graczyk, Ph.D.

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Graczyk, Ph.D.

CONTACT

216.368.5182; elg46@case.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Biomedical Engineering

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 6, 2025
• Study Start: January 13, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)