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Recruiting NCT06533969

Assessment of Neural Signals for the Control of Assistive Devices

No phase Interventional Spinal Cord Injury (SCI), Initial Encounter

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Epidural Spinal Cord Stimulation, Electrocorticographic, Electroencephalographic.
Who it may be relevant to
Registry conditions: Spinal Cord Injury (SCI), Initial Encounter. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

Interventions

  • 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
  • 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.
  • 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.

Primary outcome measures

  • Change in Hand Motor Function [Time frame: Baseline, up to 2 months post-implant]
  • Change in Hand Motor Evoked Potential (MEP) [Time frame: Baseline, up to 2 months post-implant]
Secondary outcome measures (8)
  • Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) [Time frame: Baseline, up to 2 months post-implant]
  • Change in Muscle Coordination Measured by Electromyography (EMG) [Time frame: Baseline, up to 2 months post-implant]
  • Change in Movement Kinematics [Time frame: Baseline, up to 2 months post-implant]
  • Change in Muscle Strength [Time frame: Baseline, up to 2 months post-implant]
  • Change in Quality of Life [Time frame: Baseline, up to 2 months post-implant]
  • Change in Independence Measured by Spinal Cord Independence Measure (SCIM III) [Time frame: Baseline, up to 2 months post-implant]
  • Change in Satisfaction of Life [Time frame: Baseline, up to 2 months post-implant]
  • Change in Pain Levels [Time frame: Baseline, up to 2 months post-implant]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 2 centers
  • Lynn Rehabilitation Center — Miami
  • The Miami Project to Cure Paralysis — Miami

Identifiers

NCT: NCT06533969 · 20190536

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗