Actively Recruiting
Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord
Led by The Methodist Hospital Research Institute · Updated on 2026-04-08
12
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to investigate the effects of cervical epidural spinal stimulation with upper extremity training. This is an investigational study. The device used for epidural spinal stimulation (ESS) to deliver spinal stimulation is called the CoverEdgeX 32 Surgical Lead system. This device is approved by the Food and Drug Administration (FDA) for the treatment of severe pain and to manage chronic pain when other treatments have not been effective. In this study, the device is considered an investigational device because it is not approved for use in the treatment of spinal cord injury
CONDITIONS
Official Title
Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided.
- Willing to comply with all study procedures and available for the full study duration.
- Male or female aged 22 to 65 years.
- Documentation from personal primary physician reporting a stable medical condition.
- Able to passively move both upper limbs within normal mobility ranges: >90° shoulder flexion, >20° shoulder extension, >120° elbow flexion, ~150° elbow extension, neutral wrist with at least 70° movement, and ability to flex and extend fingers.
- Maintain current oral anti-spasticity medication regimen without changes affecting study outcomes.
- Spinal cord injury between 6 months and 20 years old.
- Non-progressive spinal cord injury.
- Chronic SCI with neurologic levels AIS A, B, or C.
- Neurological injury level above T2.
- Eligible for fMRI per safety questionnaire.
- Women of childbearing potential agree to use effective pregnancy prevention during the study.
You will not qualify if you...
- Participating in another rehabilitation training study.
- Lower motor neuron injury in upper limbs.
- Cervical spine stabilization hardware preventing ESS implantation.
- Active pressure sores, wounds, unhealed fractures, peripheral neuropathies, or painful musculoskeletal dysfunction including contractures.
- Medical conditions preventing regular physical activity (e.g., ventilator dependence, cardiopulmonary disease, autonomic dysreflexia, orthostatic hypotension, active urinary infections).
- Pregnant or nursing.
- Intrathecal baclofen pump therapy for spasticity.
- Botox injections to lower extremity or trunk muscles within past 3 months.
- History of neuromuscular conditions causing pain or unhealed tears.
- Clinically significant depression, psychiatric disorders, or ongoing drug abuse.
- Any reason deemed harmful or inappropriate by the investigator or treating physician.
- Body Mass Index over 30.
- Pregnancy.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jenny Dinh
CONTACT
R
Rachel Markley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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