Cerebral PalsyNCT07826494
Short-term Spinal Stimulation Effects in Cerebral Palsy
A study testing Spinal Stimulation and Treadmill Walking in people with Cerebral Palsy, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 65 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Spinal Stimulation and Treadmill Walking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Katie Landwehr, MS, 206-543-0116, klandweh@uw.edu
About this study
Official title: Acute Effects of Transcutaneous Spinal Stimulation on Spasticity and Gait in Cerebral Palsy
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.
Read the detailed description
Children with cerebral palsy (CP) have altered neuromuscular control that impacts gait and participation in daily activities. This research will characterize the acute effects of transcutaneous spinal stimulation (tSCS) on spasticity and gait for individuals with CP using a combined approach of quantitative biomechanical assessment and clinician assessment. Previous research has shown decreases in spasticity after walking with tSCS, but it is unclear whether these changes are due to physical activity or neuromodulation. This research will provide a foundation to characterize changes in spasticity after an acute session of tSCS for individuals with CP.
This research will use the SpineX Spinal Cord Innovation in Pediatrics (SCiP) system. The SCIP system allows for tSCS intensity (mA) at two electrodes to be independently adjusted in 1 mA increments. Other stimulation parameters such as pulse frequency (30 Hz), overlap frequency (10 kHz), pulse width (1 ms), and waveform (biphasic) are constant on the SCiP device. To target sensorimotor function of lower-extremity muscle groups within the spinal cord, the two electrodes are positioned over the spinous process at T11 and L1 with grounding electrodes placed on the pelvis. The tSCS intensity will be set to each individual's maximum tolerable stimulation intensity.
This study will recruit 20 individuals with CP to attend two in-lab visits. One visit will include treadmill walking with tSCS and the other will include treadmill walking without tSCS. The visit order will be pseudo-randomized and balanced across participants. Participants will be consented at the initial visit and will also conduct 3 trials of the 10-Meter Walk Test to evaluate self-selected walking speed. The average speed from these trials will be used to set treadmill speed. At the beginning of each visit, participants will complete a physical exam to characterize range of motion and spasticity via the Modified Tardieu Scale. Participants will complete a 5-minute treadmill familiarization at their self-selected speed to ensure it is comfortable. The tSCS intensity will gradually increase during treadmill familiarization until participants report discomfort. The tSCS intensity will be set at 1 mA below the level of discomfort if the visit calls for tSCS. During the treadmill walking, participants will walk at their self-selected walking speed for 10 - 20 minutes with either (1) no stimulation or (2) tSCS at their maximum tolerable stimulation intensity.
- Conditions
- Cerebral Palsy
- Being tested
- Spinal Stimulation, Treadmill Walking
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal StimulationDevice
Also called SpineX, xStep
A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lumbar).
Treadmill WalkingOther
Participant will walk on a treadmill.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Spinal Stimulation; Other: Treadmill Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
Secondary outcomes (2)
Step Length
From quantitative gait analysis step length is quantified as the average during the final minute of walking using gait analysis and markers on the foot.
Measured: End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
Gait Deviation Index (GDI)
A multivariate metric derived from quantitative gait analysis that quantifies how much a gait cycle deviates from normative data. Average GDI calculated at the last 5 minutes of walking. Higher GDI indicates more normative walking.
Measured: Last 5 minutes of treadmill walking during visit relative to baseline at start of walking.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start13 Aug 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Katherine Steele, University of Washington
- Investigators
- Katherine Steele, PhD, Principal investigator, University of WashingtonHeather Feldner, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826494
- Sponsor's protocol ID
- STUDY00014877-A
- Other IDs
- R21HD121135
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified IPD of each outcome measure will be made available on the NICHD Data and Specimen Hub (DASH) and reported in aggregate on clinicaltrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Transcutaneous Spinal Stimulation on Spasticity and Gait in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07826494
- Acronym / sponsor ID
- STUDY00014877-A
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Children with cerebral palsy (CP) have altered neuromuscular control that impacts gait and participation in daily activities. This research will characterize the acute effects of transcutaneous spinal stimulation (tSCS) on spasticity and gait for individuals with CP using a combined approach of quantitative biomechanical assessment and clinician assessment. Previous research has shown decreases in spasticity after walking with tSCS, but it is unclear whether these changes are due to physical activity or neuromodulation. This research will provide a foundation to characterize changes in spasticity after an acute session of tSCS for individuals with CP.
This research will use the SpineX Spinal Cord Innovation in Pediatrics (SCiP) system. The SCIP system allows for tSCS intensity (mA) at two electrodes to be independently adjusted in 1 mA increments. Other stimulation parameters such as pulse frequency (30 Hz), overlap frequency (10 kHz), pulse width (1 ms), and waveform (biphasic) are constant on the SCiP device. To target sensorimotor function of lower-extremity muscle groups within the spinal cord, the two electrodes are positioned over the spinous process at T11 and L1 with grounding electrodes placed on the pelvis. The tSCS intensity will be set to each individual's maximum tolerable stimulation intensity.
This study will recruit 20 individuals with CP to attend two in-lab visits. One visit will include treadmill walking with tSCS and the other will include treadmill walking without tSCS. The visit order will be pseudo-randomized and balanced across participants. Participants will be consented at the initial visit and will also conduct 3 trials of the 10-Meter Walk Test to evaluate self-selected walking speed. The average speed from these trials will be used to set treadmill speed. At the beginning of each visit, participants will complete a physical exam to characterize range of motion and spasticity via the Modified Tardieu Scale. Participants will complete a 5-minute treadmill familiarization at their self-selected speed to ensure it is comfortable. The tSCS intensity will gradually increase during treadmill familiarization until participants report discomfort. The tSCS intensity will be set at 1 mA below the level of discomfort if the visit calls for tSCS. During the treadmill walking, participants will walk at their self-selected walking speed for 10 - 20 minutes with either (1) no stimulation or (2) tSCS at their maximum tolerable stimulation intensity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Stimulation First (AB Arm) | Experimental | Device: Spinal Stimulation, Other: Treadmill WalkingParticipants 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. |
| No Spinal Stimulation First (BA Arm) | Experimental | Device: Spinal Stimulation, Other: Treadmill WalkingParticipants 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. |
Who may qualify
- Ages
- 4 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal StimulationAlso: SpineX, xStepA stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lumbar). | Device | No Spinal Stimulation First (BA Arm), Spinal Stimulation First (AB Arm) |
| Treadmill WalkingParticipant will walk on a treadmill. | Other | No Spinal Stimulation First (BA Arm), Spinal Stimulation First (AB Arm) |
Primary outcome
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.
2 secondary outcomes
Step Length
Time frame: End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
Gait Deviation Index (GDI)
Time frame: Last 5 minutes of treadmill walking during visit relative to baseline at start of walking.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified IPD of each outcome measure will be made available on the NICHD Data and Specimen Hub (DASH) and reported in aggregate on clinicaltrials.gov.
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Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Steele, PhD principal investigator
University of Washington
Heather Feldner, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Stimulation and Treadmill Walking in people with Cerebral Palsy, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Steele, PhD (206-685-2390, kmsteele@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.