Recruiting

Spinal Stimulation

Sponsor:

University of Washington

Code:

NCT07826494

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 4 - 65

Healthy Volunteers: Not accepted

Interventions

Spinal Stimulation

Treadmill Walking

Study Details

Brief summary:

This research study will examine the acute effects of non-invasive spinal stimulation on spasticity and walking in individuals with cerebral palsy. The hypothesis is that walking with spinal stimulation will lead to greater reductions in spasticity than walking without spinal stimulation. Additionally, it is hypothesized that the average step length and Gait Deviation Index will be higher while walking with spinal stimulation compared to walking without spinal stimulation.

Conditions

Cerebral Palsy

Study ID

NCT07826494

Start date

Aug 13, 2026

Status verified date

Sep, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

Individuals who:

  • have a diagnosis of spastic cerebral palsy or high likelihood of CP diagnosis
  • are 4-65 years of age
  • have spasticity in lower-extremity muscles
  • are at a functional Gross Motor Function Classification System (GMFCS) Level I-III
  • can walk for at least 10 minutes with/without support
  • can understand and follow simple directions
  • have a stable medical condition, as reported by the caregiver/parent

Exclusion Criteria:

Individuals who:

  • who have had lower-extremity surgery or injury in the prior 12 months
  • have had botulinum toxin injections in the prior 3 months
  • have had selective dorsal rhizotomy (SDR) in the past
  • have uncontrolled seizures
  • have significant cardiovascular or musculoskeletal disease that would prevent full participation
  • are dependent on ventilation support
  • have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc) or drug delivery device (e.g. baclofen pump)
  • have established osteoporosis and taking medication for osteoporosis treatment.
  • have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
  • have active cancer
  • have received stem cell injections into the spinal cord

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Spinal Stimulation First (AB Arm)

Participants randomized into this arm will complete two visits. The first visit will use spinal stimulation while walking on a treadmill, and the second visit will be treadmill walking without stimulation.

experimental: No Spinal Stimulation First (BA Arm)

Participants randomized into this arm will complete two visits. The first visit will involve walking on a treadmill without stimulation, while the second visit will be treadmill walking with stimulation.

Interventions

Spinal Stimulation

A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lumbar).

Treadmill Walking

Participant will walk on a treadmill.

Primary outcome measure

  • Modified Tardieu Scale of Spasticity [ Time Frame: End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit. ]

Central Contacts and Locations

Central contacts

Katherine Steele, PhD

206-685-2390kmsteele@uw.edu

Katie Landwehr, MS

206-543-0116klandweh@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Katie Landwehr, MS

206-543-0116klandweh@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by University of Washington on 2026-09-17.