MedTrace Logo

Development of Optimal Sensory Feedback Strategies to Maximize Function After Tetraplegia

NCT07225582 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-02-19

No results posted yet for this study

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)

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.

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    collaborator OTHER

  • Cleveland Clinic Lerner Research Institute

    collaborator UNKNOWN

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Emily Graczyk, Ph.D. · Case Western Reserve University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-13
Primary Completion
2030-09-01
Completion
2030-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07225582 on ClinicalTrials.gov