NCT07826494 · University of Washington
Short-term Spinal Stimulation Effects in Cerebral Palsy
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Spinal Stimulation
A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lumbar).
OTHER
Treadmill Walking
Participant will walk on a treadmill.
Primary outcome measures
Modified Tardieu Scale of Spasticity
Time frame: End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
Change in quality of muscle reaction of the gastrocnemius assessed by the score on the Tardieu assessment. Lower score indicates less spasticity.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Seattle, Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 17, 2026 · Source of record for eligibility and locations