Home › Spinal Cord Injuries › NCT07204184

Multisite Transspinal Stimulation for Augmenting Recovery in Spinal Cord Injury

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

Who can join

Ages 18 to 70 · All sexes

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.

About the study

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.

What is being tested

• Multisite transspinal stimulation at rest (device)
• Multisite transspinal stimulation during robotic gait training (device)

Sponsor: Maria Knikou, PT, MBA, PhD · Participants: 36 · Started: Feb 19, 2026

Contact the study team

• MARIA KNIKOU, PT, MBA, PhD · Phone: +1-718-982-3316

Official record on ClinicalTrials.gov — NCT07204184

Locations in the U.S.

Conditions

• Spinal Cord Injuries

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.