Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT07204184

Multisite Transspinal Stimulation for Augmenting Recovery in Spinal Cord Injury

Led by Maria Knikou, PT, MBA, PhD · Updated on 2026-03-18

36

Participants Needed

1

Research Sites

123 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A well-established rehabilitation strategy for improvements of standing and walking ability in persons with spinal cord injury (SCI) is step training on a motorized treadmill with body weight support. A promising intervention is stimulation of the spinal cord through the skin (transspinal). No single intervention is likely to significantly improve long-term function after SCI on its own. Rather, combinatorial treatments that work synergistically and can be used at different clinical settings is the answer to target recovery in people with SCI. The objective of this clinical trial is to develop a non-invasive combinatorial intervention that can be used worldwide in different clinical settings. The investigators will use cervical and lumbosacral transspinal stimulation to augment the benefits of locomotor training and affect vital body functions after SCI. The investigators will deliver non-invasive cervical and lumbosacral transspinal stimulation alone or with step training to improve upright posture, walking, bladder, sex, and bowel function in persons with incomplete SCI. The noninvasive nature of the intervention holds minimal risk that outweighs the benefits.

CONDITIONS

Official Title

Multisite Transspinal Stimulation for Augmenting Recovery in Spinal Cord Injury

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willingness to comply with all study procedures and availability for the duration of the study.
  • Ability to understand the consent form and sign the consent form.
  • In good general health as evidenced by medical history.
  • Diagnosed with incomplete spinal cord injury (AIS B, C, D).
  • Bone mineral density of the hip T-score less than 3.5 SD from age- and gender-matched norms.
  • Lesion above thoracic (T) 10 to ensure no lower motoneuron lesion.
  • Presence of soleus and flexor carpi radialis (FCR) H-reflexes.
  • No permanent ankle joint contractures preventing passive or active ankle movement.
  • First time spinal cord injury due to trauma, vascular, or orthopedic causes.
  • Time since spinal cord injury is more than 6 months.
  • Stable medical condition without cardiopulmonary disease or cognitive impairment.
Not Eligible

You will not qualify if you...

  • Supraspinal lesions.
  • Neuropathies of the peripheral nervous system.
  • Significant degenerative neurological disorders of the spine or spinal cord.
  • Diagnosed with AIS A.
  • Presence of pressure sores.
  • Advanced urinary tract infection.
  • Neoplastic or vascular disorders of the spine or spinal cord.
  • Participation in an ongoing research study or new rehabilitation program.
  • Pregnant women or those who suspect they may be pregnant.
  • People with cochlear implants, pacemakers, implanted infusion devices, or implanted stimulators of any kind.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

College of Staten Island (Building 5N-218)

Staten Island, New York, United States, 10314

Actively Recruiting

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Research Team

M

MARIA KNIKOU, PT, MBA, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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