Harnessing Neuroplasticity of Postural Sensorimotor Networks Using Non-Invasive Spinal Neuromodulation to Maximize Functional Recovery After Spinal Cord Injury

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT06213012
Status
Recruiting
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Conditions

  • Neuromodulation
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
22 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous Spinal cord Stimulation — DEVICE
    Delivered using a constant-current stimulator
  • Epidural Spinal Stimulation (ESS) — DEVICE
    The device used for ESS, the CoverEdgeX 32 Surgical Lead system (Boston Scientific, USA), is a device approved by the FDA used in the treatment of severe pain and is approved for individuals to manage chronic pain when other treatments have not been effective. If you are in the ESS group, you will have surgery to have the stimulator placed and the stimulator will be removed at an office visit towards the end of the study.

Study Details

It has been demonstrated that the human lumbosacral spinal cord can be neuromodulated with epidural (ESS) and transcutaneous (TSS) spinal cord stimulation to enable recovery of standing and volitional control of the lower limbs after complete motor paralysis due to spinal cord injury (SCI). The work proposed herein will examine and identify distinct electrophysiological mechanisms underlying transcutaneous spinal stimulation (TSS) and epidural spinal stimulation (ESS) to define how these approaches determine the ability to maintain self-assisted standing after SCI.

Key Dates

Start date
Dec 6, 2023
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Transcutaneous Spinal Stimulation (TSS)
    Spinal Stimulation delivered over the skin using a research stimulator with conventional surface electrodes during research visits.
  • Sham Comparator: Sham
    Sham Stimulation delivered over the skin using a research stimulator with conventional surface electrodes during research visits. Sham stimulation will be delivered using the intensity of stimulation set as during active sessions of ESS, but then gradually decreased down to zero in approximately 30 s. There will be 5-10 minute breaks interspersed between intervals of stimulation, and will vary according to the individual's tolerance and fatigue levels
  • Experimental: Epidural Spinal Stimulation (ESS)
    Stimulation delivered internally using an implanted device operated by an external control (only used during research visits).

Primary Outcome Measure

Assessment of force generation by lower limbs [ Time Frame: Baseline 1(week 1), baseline 2(week 6), post interventions (week 11), and follow up (week 16) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030
Jenny Dinh
[email protected]
(346)-238-4654
Dimitry Sayenko, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Houston Methodist Hospital· Houston, TX

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