Recruiting

ICMS & PNS

Sponsor:

Case Western Reserve University

Code:

NCT07225582

Conditions

Spinal Cord Injury Cervical

Spinal Cord Injuries (Complete and Incomplete)

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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)

Study ID

NCT07225582

Start date

Jan 13, 2026

Status verified date

Feb, 2026

Completion date

Sep 1, 2030

Anticipated

Primary completion date

Sep 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Lack of function or operability of all implanted ReHAB system components
2. Severe pain or other chronic medical condition that would prevent the participant from completing study-related activities

Study Design

Enrollment

3 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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 measure

  • Force matching success rate [ Time Frame: From enrollment to around two years after enrollment ]
  • Object discrimination accuracy [ Time Frame: From enrollment to around two years after enrollment ]
  • Discrimination threshold [ Time Frame: From enrollment until around two years post-enrollment ]
  • Tactor detection threshold [ Time Frame: From enrollment to around two years after enrollment ]

Central Contacts and Locations

Central contacts

Emily Graczyk, Ph.D.

216.368.5182elg46@case.edu

Locations

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Emily Graczyk, Ph.D.

216-368-5182emily.graczyk@case.edu

Principal Investigator:

Emily Graczyk, Ph.D.

More Information

Sponsor

Case Western Reserve University

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2026-02-19.