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RECRUITING
NCT06533969
NA

Assessment of Neural Signals for the Control of Assistive Devices

Sponsor: University of Miami

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2024-09-06

Completion Date

2027-12-31

Last Updated

2025-09-15

Healthy Volunteers

No

Interventions

PROCEDURE

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

DEVICE

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.

DEVICE

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.

Locations (2)

Lynn Rehabilitation Center

Miami, Florida, United States

The Miami Project to Cure Paralysis

Miami, Florida, United States