Assessment of Neural Signals for the Control of Assistive Devices
NCT ID: NCT06533969
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3 participants
INTERVENTIONAL
2024-09-06
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
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
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.
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.
Interventions
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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
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 under the age of 18
* Patients unable to provide informed consent
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Jonathan Jagid
Professor of Neurological Surgery
Principal Investigators
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Jonathan R Jagid, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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Lynn Rehabilitation Center
Miami, Florida, United States
The Miami Project to Cure Paralysis
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20190536
Identifier Type: -
Identifier Source: org_study_id
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