Recruiting

Transcutaneous Stimulation

Sponsor:

Washington University School of Medicine

Code:

NCT07397559

Conditions

Spinal Cord Injuries (SCI)

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Not accepted

Interventions

No Stimulation

Conventional tSCS

Spatiotemporal tSCS

Study Details

Brief summary:

Spinal cord injury leads to long-lasting impairment, and currently, there is no cure for paralysis. Although transcutaneous spinal cord stimulation has shown promising results in recovering lost movements, its poor selectivity in muscle recruitment compared to invasive approaches limits the type of rehabilitation exercises that can be practiced. This project studies how spatial, frequency, and amplitude control of stimulation can be used to selectively target different neural pathways and muscle groups.

Conditions

Spinal Cord Injuries (SCI)

Study ID

NCT07397559

Start date

Jan 19, 2026

Status verified date

Feb, 2026

Completion date

Aug 31, 2030

Anticipated

Primary completion date

Aug 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age between 16 and 65 years.
2. Have a spinal cord injury (neurological level C3-T12) that occurred ≥1 year (chronic stage) prior to enrollment.
3. American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification C or D
4. Able to voluntarily contract (motor score ≥ 1) at least two leg muscles (visual or palpable contraction).
5. Use of prescription medication(s) for control of spasticity has not changed in the last 2 weeks
6. Able to provide consent
7. Ability to follow multiple instructions and communicate pain or discomfort

Exclusion Criteria:

1. Progressive spinal lesions, including degenerative disorders of the spinal cord
2. Pregnant, planning to become pregnant, or currently breastfeeding
3. History of cardiopulmonary disease or cardiac symptoms
4. Implanted stimulators of any type (baclofen pump, epidural spinal stimulator, cardiac defibrillator, pace-maker, etc.)
5. Presence of orthopedic conditions that would negatively affect participation in leg exercise
6. History of autonomic dysreflexia that is severe, unstable, and/or uncontrolled
7. Unstable or significant medical conditions that can interfere with exercise or neurophysiological evaluations, such as severe neuropathic pain, depression, mood disorders, or other cognitive disorders
8. Spasms that limit the ability to participate in leg exercise activity
9. Breakdown in skin area that will be in contact with electrodes

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: No stimulation

Participants complete the study motor tasks and assessments without transcutaneous spinal cord stimulation (tSCS).

active comparator: Conventional tSCS

Participants complete the same experimental tasks and assessments while receiving conventional, non-invasive transcutaneous spinal cord stimulation (tSCS) using a single cathode and 30 Hz.

experimental: Spatiotemporal tSCS

Participants complete the same tasks and assessments while receiving spatiotemporal tSCS in which stimulation parameters are systematically varied across sessions, including electrode location/configuration (spatial control), frequency, and amplitude (temporal/intensity control), to optimize targeted muscle recruitment and voluntary motor output.

Interventions

No Stimulation

Participants complete motor tasks and outcome assessments with no spinal cord stimulation applied.

Conventional tSCS

Non-invasive transcutaneous spinal cord stimulation (tSCS) is delivered at 30 Hz using a single cathode electrode targeting the lumbar spinal cord to reinforce leg motor output during study tasks

Spatiotemporal tSCS

Stimulation parameters, including electrode location, stimulation frequency, and stimulation amplitude, are systematically varied to reinforce leg motor output during study tasks

Primary outcome measure

  • Changes in Torque [ Time Frame: 30 minutes ]

Central Contacts and Locations

Central contacts

Locations

Washington University, St. Louis

Recruiting

St Louis, Missouri, United States, 63130

Contacts

More Information

Sponsor

Washington University School of Medicine

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • spinal cord injury
  • transcutaneous spinal cord stimulation
  • rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-02-12.