Actively Recruiting

Phase Not Applicable
Age: 22Years - 75Years
All Genders
ID06213012

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

N/A

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

Researchers are studying how two types of spinal cord stimulation, epidural spinal stimulation (ESS) and transcutaneous spinal stimulation (TSS), can help people with complete motor paralysis regain the ability to stand and control their lower limbs after a spinal cord injury. This study aims to understand the different physiological effects of these two stimulation methods and compare their impact on maintaining self-assisted standing in individuals with chronic spinal cord injury. The investigation focuses on improving motor function and mobility through targeted neuromodulation approaches. Participants will receive spinal stimulation either through a non-invasive method using surface electrodes placed on the skin (TSS) or through an implanted device delivering epidural stimulation (ESS). There is also a sham stimulation group where stimulation intensity is gradually reduced to zero during sessions. The study involves randomized assignment to these groups, with stimulation delivered during research visits. The ESS device involves surgery to implant and later remove the stimulator. The study also includes activity-based training combined with stimulation to assess therapeutic effects. During the study, participants will be evaluated at multiple time points including baseline, post-intervention, and follow-up weeks. Assessments include measuring force generated by the lower limbs, neurological status, and independence in daily activities. Participants must tolerate supported standing and perform self-transfers. Safety is monitored throughout, and participants are followed for several weeks after interventions to observe sustained effects. The total study duration includes baseline assessments, intervention delivery, and follow-up evaluations.

CONDITIONS

Brief 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 informed consent.
  • Willing to comply with all study procedures and available for full study duration.
  • Male or female, aged 22 to 75 years.
  • Stable medical condition confirmed by primary physician.
  • Unable to stand independently without support due to spinal cord injury AIS A-C.
  • Able to tolerate at least 15 minutes in an upright supported position.
  • Able to self-transfer from wheelchair and actively move both upper limbs.
  • Passively able to move both lower limbs within normal mobility ranges including specified hip, knee, and ankle movements.
  • On a stable anti-spasticity medication regimen unless advised otherwise.
  • Between 1 to 30 years post spinal cord injury.
  • Non-progressive spinal cord injury.
  • Neurological injury level between below C4 and above T12 (excluding certain lower motor neuron injuries).
  • Eligible for fMRI per safety screening.
  • Women of childbearing potential must use effective contraception during study.
  • Able to commit to full study participation.
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 dysfunction.
  • Medical conditions preventing regular physical activity, such as cardiopulmonary disease, uncontrollable autonomic dysreflexia or orthostatic hypotension, active infections, pregnancy, or nursing.
  • Intrathecal baclofen pump incompatible with 3T MRI.
  • Botox injections to lower extremity or trunk muscles within past 3 months affecting 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 from TMS but allowing participation in overall study, including seizure history, metal in head except mouth implants, history of suicide attempts, intracranial lesions or stroke, and current use of certain psychiatric medications such as tricyclic antidepressants, SSRIs, SNRIs, bupropion, or tramadol.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Approximately 10 weeks

Participants receive either non-invasive transcutaneous spinal cord stimulation or epidural spinal stimulation, with the latter involving surgery to implant the device.

Multiple research visits during stimulation sessions

Follow-up

Duration - 5 weeks after intervention

Participants are monitored after the intervention to assess neurological status, force generation, and independence.

1 follow-up visit

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

A

Amanda Howes-Keith, MS

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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Published Research Related To This Trial

Improvements in orthostatic instability with stand locomotor training in individuals with spinal cord injury.

Susan J Harkema, Christie K Ferreira, Rubia J van den Brand...

https://pubmed.ncbi.nlm.nih.gov/19118454

Long-term user perceptions of an implanted neuroprosthesis for exercise, standing, and transfers after spinal cord injury.

Sanjeev Agarwal, Ronald J Triolo, Rudi Kobetic...

https://pubmed.ncbi.nlm.nih.gov/14582528

Survey of the needs of patients with spinal cord injury: impact and priority for improvement in hand function in tetraplegics.

G J Snoek, M J IJzerman, H J Hermens...

https://pubmed.ncbi.nlm.nih.gov/15224087