Assessment of Neural Signals for the Control of Assistive Devices
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients that are pregnant
Patients under the age of 18
Patients unable to provide informed consent
Trial design
Design model
Single group
Treatments tested in this trial
Epidural Spinal Cord Stimulation
Procedure/SurgeryThis 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
Electrocorticographic
DeviceNeural 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.
Electroencephalographic
DeviceNeural 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.
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: Brain Computer Interface-Epidural Spinal Cord Stimulation (BCI-ESCS)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, up to 2 months post-implant2
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).
Time frame
Baseline, up to 2 months post-implantSecondary outcomes
1
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.
Time frame
Baseline, up to 2 months post-implant2
Change in Muscle Coordination Measured by Electromyography (EMG)
Functional tasks: Assessments to measure reaching ability and obtain muscle coordination via EMG (millivolts).
Time frame
Baseline, up to 2 months post-implant3
Change in Movement Kinematics
Kinematics data (motion capture, measured in centimeters) at time points before and after implant.
Time frame
Baseline, up to 2 months post-implant4
Change in Muscle Strength
Muscle force testing: Assessment of changes in muscle strength from measured in Newtons at time points before and after implant.
Time frame
Baseline, up to 2 months post-implantSponsors and contacts
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Source ClinicalTrials.gov