Recruiting

Neural Signals

Sponsor:

University of Miami

Code:

NCT06533969

Conditions

Spinal Cord Injury (SCI), Initial Encounter

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Epidural Spinal Cord Stimulation

Electrocorticographic

Electroencephalographic

Study Details

Brief summary:

The study will investigate the use of motor intention-based cortical signals to trigger epidural spinal cord stimulation (ESCS) with individuals with SCI. Motor intention of UL tasks will be decoded using brain-computer interface (BCI) system based on cortical signals recorded using an Electroencephalographic (EEG) system or using their intracranially implanted devices Electrocorticographic (ECoG).

Conditions

Spinal Cord Injury (SCI), Initial Encounter

Study ID

NCT06533969

Start date

Sep 6, 2024

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients age 18 and older
  • Able to sign informed consent
  • Not participating in other studies that limit participation
  • Chronic (>6 month) traumatic Spinal Cord Injury (SCI) (C4-T1 neurological injury with American Spinal Injury Association Impairment Scale (AIS A-D) with some residual function.

Exclusion Criteria:

  • Patients that are pregnant
  • Patients under the age of 18
  • Patients unable to provide informed consent

Study Design

Enrollment

3 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Brain Computer Interface-Epidural Spinal Cord Stimulation (BCI-ESCS)

Participants in this group will receive a onetime surgery to have the leads implanted temporarily for ESCS which will be triggered through the BCI system. The BCI-ESCS arms will include Upper limb (UL) therapist-guided training, with triggered through a BCI system during task practice. The BCI system will decode motor intention of Upper limb (UL) tasks from cortical signals recorded using EEG system or using their intracranially implanted devices (e.g., ECoG). Participants will perform UL daily activities (e.g., grasping, reaching) tailored to participants deficits. The therapist will facilitate task practice and progress therapy within and between session.

Subjects will be involved in the intervention for up to 2 months.

Interventions

Epidural Spinal Cord Stimulation

This will be a one time surgery lasting no more than 2 hours where ESCS electrodes will be connected to an external stimulator approved for human research. Stimulation intensity and parameters will be configured before each session for optimal upper extremity motor function.

The ESCS approach will include surgical implantation of temporarily placed leads in the cervical epidural space and connection cables tunneled percutaneously through the skin for <30 days

Electrocorticographic

Neural activity during upper and/or lower extremity tasks will be recorded to characterize the changes that occur in the signals before, during, and after task performance. Observed characteristics of neural signals that are related to the initiation, continuation, or termination of movement will be used to derive control signals that can trigger or enable assistive devices.

Electroencephalographic

Neural activity during upper and/or lower extremity tasks will be recorded to characterize the changes that occur in the signals before, during, and after task performance. Observed characteristics of neural signals that are related to the initiation, continuation, or termination of movement will be used to derive control signals that can trigger or enable assistive devices.

Primary outcome measure

  • Change in Hand Motor Function [ Time Frame: Baseline, up to 2 months post-implant ]
  • Change in Hand Motor Evoked Potential (MEP) [ Time Frame: Baseline, up to 2 months post-implant ]

Central Contacts and Locations

Central contacts

Locations

The Miami Project to Cure Paralysis

Recruiting

Miami, Florida, United States, 33136

Contacts

Letitia Fisher, BLA

3052433056lfisher@miami.edu

Matija Milosevic, Co-I, PhD

305-243-3572mmilosevic@med.miami.edu

Principal Investigator:

Jonathan R. Jagid, MD

More Information

Sponsor

University of Miami

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • Brain Computer Interface
  • Epidural Spinal Cord Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-08-26.