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RECRUITING Not applicable ClinicalTrials.gov

Assessment of Neural Signals for the Control of Assistive Devices

Sponsor: University of Miami • ClinicalTrials.gov ID: NCT06533969

Registry updated: 2026-08-26
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Description

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).

Interventions

  • Epidural Spinal Cord Stimulation (Procedure)
    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 (Device)
    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 (Device)
    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.

Eligibility criteria

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

Conditions

Spinal Cord Injury (SCI), Initial Encounter

Locations

  • Lynn Rehabilitation Center — Miami, Florida, United States
  • The Miami Project to Cure Paralysis — Miami, Florida, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record