Assessment of Neural Signals for the Control of Assistive Devices

University of Miami

Status: Enrolling

Conditions: Spinal Cord Injury (SCI), Initial Encounter

Treatments: Device: Electroencephalographic; Procedure: Epidural Spinal Cord Stimulation; Device: Electrocorticographic

Study type: Interventional

Funder types: Other

Identifiers

NCT06533969

20190536

Details and patient eligibility

About

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).

Enrollment: 3 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Device: Electrocorticographic

Device: Electroencephalographic

Procedure: Epidural Spinal Cord Stimulation