Assessment of Neural Signals for the Control of Assistive Devices

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).

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injury (SCI), Initial Encounter
• Intervention / Treatment: Procedure: Epidural Spinal Cord Stimulation; Device: Electrocorticographic; Device: Electroencephalographic

• Study Type: Interventional
• Enrollment (Estimated): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Letitia Fisher; Phone Number: 305-243-3056; Email: lfisher@miami.edu
• Study Contact Backup: Name: Matija Milosevic, PhD; Phone Number: 305-243-3572; Email: mxm194475@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • The Miami Project to Cure Paralysis
      • Contact: Letitia Fisher, BLA; Phone Number: 305-243-3056; Email: lfisher@miami.edu
      • Principal Investigator: Jonathan R. Jagid, MD
      • Contact: Matija Milosevic, Co-I, PhD; Phone Number: 305-243-3572; Email: mmilosevic@med.miami.edu
      • Sub-Investigator: Joacir Graciolli., MD, PhD
      • Sub-Investigator: Mitja Milosevic, PhD
    • Miami, Florida, United States, 33136
      • Not yet recruiting
      • Lynn Rehabilitation Center
      • Principal Investigator: Jonathan R Jagid, MD
      • Contact: Letitia Fisher; Phone Number: 305-243-3056; Email: lfisher@miami.edu
      • Contact: Matija Milosevic, PhD; Phone Number: 3052433572; Email: mxm194475@miami.edu
      • Principal Investigator: Joacir Graciolli, MD, PhD
      • Sub-Investigator: Abhishek Prasad, PhD
      • Sub-Investigator: Matija Milosevic, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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; Other Names: ESCS; 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.; Other Names: ECoG; 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.; Other Names: EEG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Jonathan R Jagid, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Brain Computer Interface; Epidural Spinal Cord Stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Electrodiagnosis; Electroencephalography
• Other Study ID Numbers: 20190536

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No