Short-term Spinal Stimulation Effects in Cerebral Palsy

NCT07826494 | Recruiting FDA Device

• 2 other identifiers: STUDY00014877-AR21HD121135
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Modified Tardieu Scale of Spasticity

  Change in quality of muscle reaction of the gastrocnemius assessed by the score on the Tardieu assessment. Lower score indicates less spasticity.

  End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.

Secondary Outcomes (2)

• Step Length

  End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.

• Gait Deviation Index (GDI)

  Last 5 minutes of treadmill walking during visit relative to baseline at start of walking.

Study Arms (2)

Spinal Stimulation First (AB Arm)

EXPERIMENTAL

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.

Device: Spinal Stimulation; Other: Treadmill Walking

No Spinal Stimulation First (BA Arm)

EXPERIMENTAL

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.

Device: Spinal Stimulation; Other: Treadmill Walking

Interventions

Spinal Stimulation DEVICE

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

Also known as: SpineX, xStep

No Spinal Stimulation First (BA Arm); Spinal Stimulation First (AB Arm)

Treadmill Walking OTHER

Participant will walk on a treadmill.

No Spinal Stimulation First (BA Arm); Spinal Stimulation First (AB Arm)

Eligibility Criteria

• Age: 4 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Katherine Steele, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Heather Feldner, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Steele, PhD

CONTACT

206-685-2390; kmsteele@uw.edu

Katie Landwehr, MS

CONTACT

206-543-0116; klandweh@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participant and caregiver is not informed about the order of visits with and without stimulation and are told that they "may or may not feel stimulation" at each visit. During the visit without stimulation, the electrodes are still placed and connected to the device without delivering stimulation.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 17, 2026
• Study Start: August 13, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be made available 6 months following publication of study results.
• Access Criteria: Direct access with registration on NIH repository.

Locations

US (1)