Recruiting

Transspinal Stimulation, Step Training

Sponsor:

Maria Knikou, PT, MBA, PhD

Code:

NCT07204184

Conditions

Spinal Cord Injuries (Complete and Incomplete)

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Multisite transspinal stimulation at rest

Multisite transspinal stimulation during robotic gait training

Study Details

Brief summary:

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

Spinal Cord Injuries (Complete and Incomplete)

Study ID

NCT07204184

Start date

Feb 19, 2026

Status verified date

Mar, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Multisite transspinal stimulation at rest

Cervical and lumbosacral non-invasive transspinal tonic stimulation will be delivered at 30 Hz frequency (charge-balanced, symmetric, biphasic rectangular pulses of a 1-ms width per phase) at paresthesia levels or higher depending on each participant's comfort level while participants rest lying on the back. A total of 20 sessions (weekdays excluding weekends and holidays), each for 1 hour, will be administered.

active comparator: Multisite transspinal stimulation during robotic gait training

The investigators will deliver cervical and lumbosacral non-invasive transspinal tonic stimulation at 30 Hz frequency (charge-balanced, symmetric, biphasic rectangular pulses of a 1-ms width per phase) at paresthesia levels or higher depending on each participant's comfort level during assisted stepping with the Lokomat 6 Pro, a robotic device that helps the legs step and provides as needed body weight support. A total of 20 sessions (weekdays excluding weekends and holidays), each for 1 hour, will be administered.

Interventions

Multisite transspinal stimulation at rest

The intervention, combined cervical and lumbar transspinal stimulation, will be used for the first time to reconnect the spared neuronal pathways of the injured human spinal cord. The intervention will be administered while at rest lying on the back or during robotic gait training. Cervical and lumbar transspinal stimulation will be delivered via surface active electrodes placed on the back of the neck and on low back, and four returning electrodes placed on each clavicle and iliac crest.

Multisite transspinal stimulation during robotic gait training

The intervention, combined cervical and lumbar transspinal stimulation, will be administered during robotic gait training. Cervical and lumbar transspinal stimulation will be delivered via surface active electrodes placed on the back of the neck and on low back, and four returning electrodes placed on each clavicle and iliac crest while participants step with the help of the Lokomat 6 Pro, a robotic device that helps the legs step. Locomotor training will depend on the ability of each participant to step without foot dragging. Over the training course, we will adjust the body weight support, ankle straps position, and leg guidance force. The tension of the ankle straps will be adjusted based on the right and left tibialis anterior muscle strength evaluated every 2 weeks. Body weight support and leg guidance force will be adjusted based on presence or absence of knee buckling during standing.

Primary outcome measure

  • Soleus H-reflex recruitment curve [ Time Frame: Before and 1 day after all intervention sessions are completed. ]
  • Soleus H-reflex rate-dependent depression [ Time Frame: Before and 1 day after all intervention sessions are completed. ]
  • Soleus H-reflex phase-dependent modulation during stepping [ Time Frame: Before and 1 day after all intervention sessions are completed. ]
  • Leg transspinal evoked potentials recruitment curves [ Time Frame: Before and 1 day after all intervention sessions are completed. ]
  • Flexor carpus radialis H-reflex recruitment curve [ Time Frame: Before and 2 days after all intervention sessions are completed. ]
  • Flexor carpus radialis H-reflex rate dependent depression [ Time Frame: Before and 2 days after all intervention sessions are completed. ]
  • Arm transspinal evoked potentials recruitment curves [ Time Frame: Before and 2 days after all intervention sessions are completed. ]

Central Contacts and Locations

Central contacts

MARIA KNIKOU, PT, MBA, PhD

+1-718-982-3316maria.knikou@csi.cuny.edu

Locations

College of Staten Island (Building 5N-218)

Recruiting

Staten Island, New York, United States, 10314

Contacts

MARIA KNIKOU, PT, MBA, PhD

718-982-3316maria.knikou@csi.cuny.edu

More Information

Sponsor

Maria Knikou, PT, MBA, PhD

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • transspinal stimulation
  • robotic gait training
  • locomotor training
  • non-invasive
  • multi-modal rehabilitation
  • clinical biomarkers
  • neurophysiological biomarkers
  • sensorimotor recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maria Knikou, PT, MBA, PhD on 2026-03-18.