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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the effects of cervical epidural spinal stimulation (ESS) combined with upper extremity training in people with spinal cord injuries (SCI). The trial focuses on using the CoverEdgeX 32 Surgical Lead system, an FDA-approved device for pain management but investigational for treating spinal cord injury, to explore its potential in improving upper limb sensorimotor function. The study targets adults aged 22 to 65 with chronic, non-progressive cervical SCI above the T2 level and aims to understand how ESS may support neurological recovery and rehabilitation. The study involves implanting ESS electrodes with external leads in twelve participants during Week 2 after initial screening. Following implantation, participants enter a recovery phase and then undergo detailed assessments of sensorimotor responses, brain activity, and upper limb function. Participants receive ESS therapy combined with upper limb and trunk training during Weeks 5 and 6. Based on their response, some will receive a permanent implantable pulse generator (IPG), while non-responders will have the electrodes removed. The stimulation is delivered during study visits for up to 1 hour at varying frequencies and intensities adjusted to elicit muscle responses. Participants will attend multiple visits over approximately 16 weeks, including clinical exams, neuroimaging, electrophysiological assessments, and functional tests to monitor muscle response and neurological status. The study measures upper limb muscle responses at several time points, along with assessments of neurological function and independence. Safety and tolerance are monitored throughout, with rest periods and parameter refinements included. This detailed follow-up aims to evaluate how ESS influences rehabilitation outcomes and brain connectivity after cervical spinal cord injury.
CONDITIONS
Brief Title
Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must provide signed informed consent.
- Willingness to comply with all study procedures and availability for the study duration.
- Male or female aged 22 to 65 years old.
- Documentation from primary physician confirming stable medical condition.
- Ability to passively move both upper limbs within normal range: >90° shoulder flexion, >20° shoulder extension, >120° elbow flexion, ~150° elbow extension, neutral wrist with 70° movement, and finger flexion/extension.
- Maintain current approved oral anti-spasticity medication without dose changes affecting study outcomes.
- 6 months to 20 years post spinal cord injury.
- Non-progressive spinal cord injury.
- Neurologic injury level above T2 with ISNCSCI AIS A, B, or C classification.
- Eligible for fMRI per safety screening.
- Women of childbearing potential must agree to use effective pregnancy prevention during the study.
You will not qualify if you...
- Participation in another rehabilitation training study.
- Lower motor neuron injury in upper limbs.
- Cervical spine hardware preventing ESS implantation.
- Active pressure sores, wounds, unhealed fractures, peripheral neuropathies, or painful musculoskeletal issues including contractures.
- Medical conditions preventing regular physical activity, including ventilator dependence, cardiopulmonary disease, uncontrolled autonomic dysreflexia or orthostatic hypotension, active urinary infections, pregnancy, or nursing.
- Intrathecal baclofen pump therapy for spasticity.
- Botox injections to lower extremity or trunk muscles within past 3 months that affect muscle tone.
- Current or history of neuromuscular conditions causing pain or unhealed injuries affecting limbs.
- Significant depression, psychiatric disorders, or ongoing drug abuse.
- Any condition deemed harmful or inappropriate by the principal investigator or treating physician.
- Body Mass Index over 30.
- Pregnancy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants will have epidural spinal stimulation (ESS) electrodes implanted with externalized leads.
1 visit (in-person)
Duration - 1 week
Participants undergo a recovery phase following electrode implantation.
1 visit (in-person)
Duration - 1 week
Participants undergo electrophysiological, neuroimaging, and functional assessments to characterize sensorimotor network responses to ESS and evaluate upper limb sensorimotor function.
1 visit (in-person)
Duration - 2 weeks
Participants receive combined therapies for upper limb and trunk sensorimotor functions alongside cervical ESS during study visits.
Weekly visits for 2 weeks (in-person)
Duration - 1 week
Participants undergo repeated assessments to evaluate responses to ESS; responders receive permanent implant, non-responders have ESS electrodes removed.
1 visit (in-person)
Duration - 2 weeks
Participants have a rest period with repeated clinical examinations to monitor progress.
2 visits (in-person)
Duration - 1 week
Participants undergo assessments with ESS active for only 30 seconds (sham stimulation) during study visits.
1 visit (in-person)
Duration - 3 weeks
Participants continue therapy with ESS and undergo refinement of ESS parameters to enhance functional movements.
Weekly visits for 3 weeks (in-person)
Duration - 1 week
Participants complete a post-intervention clinical examination to assess outcomes after the trial.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jenny Dinh
R
Rachel Markley
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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