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Clinical trial Recruiting at 1 site Interventional Ages 18 to 70

Paired neck and lower‑back spinal stimulation to help standing and walking after spinal cord injury

Official title: Cervical and Lumbosacral Transspinal Stimulation to Reconnect the Injured Human Spinal Cord

Run by City University of New York · NCT07204184 · Data updated 2026-11-12

This trial will test whether non‑invasive electrical stimulation over the neck and lower back, alone or combined with robotic step training, can help people with incomplete spinal cord injury improve standing and walking.

Quick facts

Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment36 (estimated)
SponsorCity University of New York
Academic / other
Locations1 site (Staten Island, New York)
StatusRecruiting
StartedFebruary 19, 2026
Main results expectedJune 30, 2028
Study endsJune 30, 2028
Registry record updatedMarch 18, 2026
Trial IDNCT07204184 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with chronic (>6 months) incomplete spinal cord injury (AIS B, C, or D), lesion above T10, measurable soleus and FCR H‑reflexes, stable medical status, and ability to attend visits are ideal candidates.

Probably not a fit

People with complete spinal cord injuries, lower motor neuron lesions, supraspinal lesions, or who lack measurable H‑reflexes or flexible ankle joints are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial applies non‑invasive transspinal stimulation over the cervical and lumbosacral enlargements, delivered either at rest or during robotic (Lokomat) assisted step training, to adults with chronic incomplete spinal cord injury. Investigators will record neurophysiological measures (H‑reflexes and transspinal evoked potentials) and analyze joint coordination and muscle synergies during treadmill stepping, with comparisons to healthy control subjects for mechanistic insight. The study is designed to establish safety and preliminary efficacy signals and to explore how paired cervical and lumbosacral stimulation may augment locomotor rehabilitation. Findings will inform whether this non‑invasive combinatorial approach could be advanced to larger multi‑site trials and routine clinical use.

Why it matters

Potential benefit: If successful, this approach could improve standing and walking function and related autonomic or motor control outcomes for people with incomplete spinal cord injuries.

How similar studies have gone: Prior small studies of transcutaneous/transspinal stimulation have shown promising changes in muscle activation and stepping, but paired cervical plus lumbosacral stimulation combined with robotic gait training is a relatively novel combinatorial approach that requires confirmation.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 SCI (AIS B, C, D).
* Bone mineral density of the hip (proximal femur) T-score \<3.5 SD from age- and gender-matched normative data.
* Lesion above thoracic (T) 10 to ensure absent lower motoneuron lesion.
* The presence of soleus and FCR H-reflexes.
* Absent permanent ankle joint contractures prevent passive or active ankle movement because corticospinal and spinal excitability is based on the ankle angle. The ankle straps of the Lokomat also require flexible ankle joints.
* A diagnosis of first time SCI due to trauma, vascular, or orthopedic pathology.
* Time after SCI of more than 6 months.
* Stable medical condition without cardiopulmonary disease or cognitive impairment.

Exclusion Criteria:

* 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 women who suspect they may be or may become pregnant will be excluded from participation because the risks of thoracolumbar stimulation to the fetus are unknown.
* People with cochlear implants, pacemakers, implanted infusion device, and/or implanted stimulators of any type and purpose will be excluded to avoid their malfunction due to stimulation.

Where it's running

  • College of Staten Island (Building 5N-218)
    Staten Island, New York, United States     Recruiting

Study contacts

  • Principal investigator: MARIA KNIKOU, PT, MBA, PhD — City University of New York, College of Staten Island
  • Study coordinator: MARIA KNIKOU, PT, MBA, PhD
  • Email: maria.knikou@csi.cuny.edu
  • Phone: +1-718-982-3316

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.