Assessment of Neural Signals for the Control of Assistive Devices
NCT Number: NCT06533969
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Cord Injury (SCI), Initial Encounter
Interventions: PROCEDURE: Epidural Spinal Cord Stimulation|DEVICE: Electrocorticographic|DEVICE: Electroencephalographic
Sponsor: University of Miami
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10-01
Completion Date: 2025-10-01
Locations: Lynn Rehabilitation Center, Miami, Florida, 33136, United States

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).

Primary Outcome Measures: Change in Hand Motor Function, Toronto Rehabilitation Institute Hand Function Test (TRI-HFT): Measured on a scale from 0-133 to assess upper extremity manipulation and grip force at time points before and after implant.

Higher scores indicate better hand motor function., Baseline, up to 2 months post-implant|Change in Hand Motor Evoked Potential (MEP), Change in Motor Evoked Potential (MEP): MEP evaluates corticospinal excitability (strength of the connections between the brain and the muscles). The excitability is measured as a peak-to-peak amplitude in millivolts (mV)., Baseline, up to 2 months post-implant
Secondary Outcome Measures: Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP), Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP): Standardized test to be measured on a scale from 0-116 through the combination of five subset scores to assess grasping ability at time points before and after implant. A composite score will be obtained for strength, muscle force and tasks.

Higher scores indicate better hand motor function., Baseline, up to 2 months post-implant|Change in Muscle Coordination Measured by Electromyography (EMG), Functional tasks: Assessments to measure reaching ability and obtain muscle coordination via EMG (millivolts)., Baseline, up to 2 months post-implant|Change in Movement Kinematics, Kinematics data (motion capture, measured in centimeters) at time points before and after implant., Baseline, up to 2 months post-implant|Change in Muscle Strength, Muscle force testing: Assessment of changes in muscle strength from measured in Newtons at time points before and after implant., Baseline, up to 2 months post-implant|Change in Quality of Life, Quality of Life using the International Spinal Cord Injury - Quality of Life (ISCI-QOL): ISCI-QOL consists of three single items on satisfaction with life as a whole, physical health, and psychological health using a 0-10 scale where 0=complete dissatisfaction; 10=complete satisfaction.

A composite score will be obtained for this measure., Baseline, up to 2 months post-implant|Change in Independence Measured by Spinal Cord Independence Measure (SCIM III), Independence as measured by Spinal Cord Independence Measure (SCIM III): SCIM III assesses performance in activities of daily living Scores range from 0-100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence., Baseline, up to 2 months post-implant|Change in Satisfaction of Life, Medical Outcomes Study Short Form 36 (SF-36): Patient-reported outcome measurement for health-related quality of life and activities of daily living scored on a scale of 0 (negative health) to 100 (positive health)., Baseline, up to 2 months post-implant|Change in Pain Levels, Brief Pain Inventory (BPI): A questionnaire for pain will be assessed on a scale of 0 ("no pain") to 10 ("worst imaginable pain") at different points before and after the implant., Baseline, up to 2 months post-implant