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NCT Number: NCT06533969

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).

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Key information

Conditions

Spinal Cord Injury (SCI), Initial Encounter Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lynn Rehabilitation Center, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: ESCS

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.

Other names: ECoG

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.

Other names: EEG

Primary outcomes

  1. Change in Hand Motor Function

    Time frame: Baseline, up to 2 months post-implant

    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.

  2. Change in Hand Motor Evoked Potential (MEP)

    Time frame: Baseline, up to 2 months post-implant

    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).

Secondary outcomes

  1. Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)

    Time frame: Baseline, up to 2 months post-implant

    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.

  2. Change in Muscle Coordination Measured by Electromyography (EMG)

    Time frame: Baseline, up to 2 months post-implant

    Functional tasks: Assessments to measure reaching ability and obtain muscle coordination via EMG (millivolts).

  3. Change in Movement Kinematics

    Time frame: Baseline, up to 2 months post-implant

    Kinematics data (motion capture, measured in centimeters) at time points before and after implant.

  4. Change in Muscle Strength

    Time frame: Baseline, up to 2 months post-implant

    Muscle force testing: Assessment of changes in muscle strength from measured in Newtons at time points before and after implant.

  5. Change in Quality of Life

    Time frame: Baseline, up to 2 months post-implant

    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.

  6. Change in Independence Measured by Spinal Cord Independence Measure (SCIM III)

    Time frame: Baseline, up to 2 months post-implant

    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.

  7. Change in Satisfaction of Life

    Time frame: Baseline, up to 2 months post-implant

    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).

  8. Change in Pain Levels

    Time frame: Baseline, up to 2 months post-implant

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Letitia Fisher

CONTACT

[email protected]

305-243-3056

Matija Milosevic, PhD

CONTACT

[email protected]

305-243-3572

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 1, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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