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Procedure

Neural Signals for Spinal Cord Injury

N/A

Recruiting

Led By Jonathan R Jagid, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Be older than 18 years old

Must not have

Patients unable to provide informed consent

Patients under the age of 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, up to 2 months post-implant

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at using brain signals related to movement to activate spinal cord stimulation in individuals with spinal cord injury. The participants will use a brain-computer interface system to decode signals from their brain while

Who is the study for?

This trial is for individuals with spinal cord injuries who are interested in testing new ways to control assistive devices using their brain signals. Participants should be willing to have their brain activity monitored and decoded, either through non-invasive EEG or implanted ECoG devices.

What is being tested?

The study tests if motor intentions detected by a brain-computer interface (BCI) can effectively trigger epidural spinal cord stimulation (ESCS) to help control assistive devices. It uses EEG systems or intracranial ECoG implants to record and decode these signals.

What are the potential side effects?

Potential side effects may include discomfort at the site of electrode placement, skin irritation from EEG sensors, headaches, fatigue after sessions, and risks associated with surgical implantation for those using ECoG.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a spinal cord injury for over 6 months with some remaining function.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand or sign the consent form.

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I am younger than 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, up to 2 months post-implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, up to 2 months post-implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 2 months post-implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Hand Motor Evoked Potential (MEP)

Change in Hand Motor Function

Secondary study objectives

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

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

Change in Movement Kinematics

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Brain Computer Interface-Epidural Spinal Cord Stimulation (BCI-ESCS)Experimental Treatment3 Interventions

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.

0 / 3Eligibility criteria met