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Electrical Stimulation

Electrical Stimulation for Spinal Cord Injury

N/A

Recruiting

Led By Matija Milosevic, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

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

Must have

- Traumatic spinal cord injury (SCI) with neurological level at or above T1 spinal cord level and AIS A, B, C, or D impairment grade

Patients with detectable motor function in at least 1 upper extremity muscle on 1 neurologically affected side confirmed by voluntary electromyography (EMG) or detectable motor evoked potential (MEP) at the baseline assessment

Must not have

Patients with major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities

Patients with traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate how functional electrical stimulation (FES) therapy impacts the functioning of the arms, brain, and spinal cord in individuals with spinal cord injury (SCI) or peripheral nerve injury (

Who is the study for?

This trial is for individuals with spinal cord injury (SCI) or peripheral nerve injury (PNI) who are looking to improve their upper extremity function. Participants should be interested in undergoing functional electrical stimulation therapy.

What is being tested?

The study compares the effects of MyndMove therapy over different durations against conventional therapy on arm, brain, and spinal cord function after SCI or PNI. It aims to understand recovery patterns using this innovative FES system.

What are the potential side effects?

While not explicitly stated, side effects of FES may include skin irritation at the electrode sites, muscle fatigue, discomfort during stimulation, and potential muscle soreness post-therapy.

Eligibility Criteria

Inclusion Criteria

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

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I have a spinal cord injury at or above T1 with a specific impairment grade.

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I have some muscle movement in one arm, confirmed by a muscle test.

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I can see my muscle move in one of my arms when it is electrically stimulated.

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I have a nerve injury in my arm, with or without spinal cord injury, and might have or plan to have nerve transfer surgery.

Exclusion Criteria

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

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I do not have major cognitive issues or severe health problems.

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I have a condition like a brain injury or MS that affects my movement.

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I don't have skin issues, thrombosis, or diseases affecting electrode contact areas.

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I have an unhealed fracture, contracture, or sore on my arm.

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I am not on any experimental drugs or treatments that could affect my muscle control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Graded-Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) Prehension Performance (GR-PP)

Manual Muscle Test (MMT) with FES

Nine Hole Peg Test

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Chronic SCI GroupExperimental Treatment3 Interventions

Individuals with traumatic spinal cord injury (SCI) with a neurological level at or above T1 spinal cord level; Abbreviated Injury Scale (AIS) A, B, C or D impairment grade; more than 6 months post injury. Participants in this group will be in the study for up to 12 weeks

Group II: Chronic PNI GroupExperimental Treatment3 Interventions

Individuals with PNI that are 6 months or more post-UE nerve transfer surgery. Participants in this group will be in the study for up to 12 weeks

Group III: Acute SCI GroupExperimental Treatment3 Interventions

Individuals with traumatic spinal cord injury (SCI) with a neurological level at or above T1 spinal cord level; Abbreviated Injury Scale (AIS) A, B, C or D impairment grade; less than 6 months post injury. Participants in this group will be in the study for up to 12 weeks

Group IV: Acute PNI GroupExperimental Treatment3 Interventions

Individuals with PNI that are within 6 months pre- or post-UE nerve transfer surgery. Participants in this group will be in the study for up to 12 weeks

0 / 9Eligibility criteria met