Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT06225245
Status
Recruiting
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Conditions

  • Cervical Spinal Cord Injury
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Epidural Spinal Stimulation (ESS) — DEVICE
    ESS will be delivered using The CoverEdgeX 32 Surgical Lead at frequencies of 0.2 to 60 Hz with intensity up to 10 mA, adjusted to induce motor threshold responses in the target muscle for the above motor task (e.g., biceps brachii for elbow flexion) \[31-33\]. The ESS controller will only be operated by trained study team members. Therefore, stimulation will only be delivered during study visits. Stimulation will be administered for a maximum duration of 1 hour total per visit, varying according to the individual's tolerance and fatigue levels, with 5 - 10 minutes breaks interspersed between intervals of stimulation.

Study Details

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

Key Dates

Start date
Aug 6, 2024
Status verified
Mar 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Epidural Spinal Stimulation (ESS)
    ESS will be delivered using The CoverEdgeX 32 Surgical Lead at frequencies of 0.2 to 60 Hz with intensity up to 10 mA, adjusted to induce motor threshold responses in the target muscle for the above motor task (e.g., biceps brachii for elbow flexion) \[31-33\]. The ESS controller will only be operated by trained study team members. Therefore, stimulation will only be delivered during study visits. Stimulation will be administered for a maximum duration of 1 hour total per visit, varying according to the individual's tolerance and fatigue levels, with 5 - 10 minutes breaks interspersed between intervals of stimulation.

Primary Outcome Measure

Assessment of Upper Limb Muscle Response [ Time Frame: Baseline (Week 4), Post Intervention (Week 7), Follow up (Week 10), Follow up (Week 13) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Methodist Hospital Research InstituteHoustonTexas77030
Jenny Dinh
[email protected]
346-238-4654
Dimitry G Sayenko, MD, PhD (PRINCIPAL_INVESTIGATOR)

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The Methodist Hospital Research Institute· Houston, TX

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