Actively Recruiting

Phase Not Applicable
Age: 22Years - 75Years
All Genders
NCT06213012

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

Led by The Methodist Hospital Research Institute · Updated on 2026-03-30

60

Participants Needed

1

Research Sites

194 weeks

Total Duration

On this page

Sponsors

T

The Methodist Hospital Research Institute

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 22Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide signed and dated informed consent.
  • Willing to comply with all study procedures and available for the full study duration.
  • Male or female, aged 22 to 75 years.
  • Stable medical condition confirmed by primary physician.
  • Unable to stand independently without external support due to spinal cord injury AIS A-C.
  • Able to tolerate at least 15 minutes in an upright supported position.
  • Able to transfer self from wheelchair and actively move both upper limbs.
  • Able to passively move both lower limbs within specified normal ranges (hip flexion >90°, hip extension >165°, knee flexion >90°, knee extension to 180°, ankle dorsiflexion minimum 90°).
  • On stable intrathecal baclofen or oral anti-spasticity medication during the study unless otherwise advised.
  • Between 1 and 30 years post spinal cord injury.
  • Non-progressive spinal cord injury.
  • Neurological injury level between below C4 and above T12, excluding conus injury or lower motor neuron injury.
  • Eligible for fMRI based on safety screening.
  • Women of childbearing potential agree to use effective pregnancy prevention during the study.
  • Able to commit to the entire study.
Not Eligible

You will not qualify if you...

  • Able to stand independently without external support.
  • Currently participating in other lower extremity rehabilitation training.
  • Active pressure sores, unhealed fractures, peripheral neuropathies, or painful musculoskeletal issues including contractures.
  • Medical conditions preventing regular physical activity, such as cardiopulmonary disease, uncontrollable autonomic dysreflexia, orthostatic hypotension, active urinary tract infections, pregnancy, or nursing.
  • Intrathecal baclofen pump therapy incompatible with 3T MRI.
  • Botox injections to lower extremity or trunk muscles within past 3 months causing absence of muscle tone.
  • Current or past neuromuscular conditions causing pain or unhealed injuries in limbs.
  • Significant depression, psychiatric disorders, or ongoing substance abuse including heavy alcohol use.
  • Any condition deemed harmful by the principal investigator or treating physician.
  • Body mass index over 30.
  • Pregnancy.
  • Use of ventilator or diaphragmatic pacer.
  • Conditions excluding participation in TMS but allowing study participation: personal or family history of seizures or epilepsy, metal in the head (except mouth implants), history of suicide attempts, intracranial lesions, increased intracranial pressure, stroke, or use of certain antidepressants and pain medications.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Houston Methodist Hospital

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

J

Jenny Dinh, BS

CONTACT

A

Amanda Howes-Keith, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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