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Short-term Spinal Stimulation Effects in Cerebral Palsy

14 september 2026 bijgewerkt door: Katherine Steele, University of Washington

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Katherine Steele, PhD
  • Telefoonnummer: 206-685-2390
  • E-mail: kmsteele@uw.edu

Studie Contact Back-up

  • Naam: Katie Landwehr, MS
  • Telefoonnummer: 206-543-0116
  • E-mail: klandweh@uw.edu

Studie Locaties

  • Verenigde Staten
    • Washington
      • Seattle, Washington, Verenigde Staten, 98195
        • Werving
        • University of Washington
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: Spinal Stimulation
A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lumbar).
Andere namen:
  • SpineX
  • xStep
Ander: Treadmill Walking
Participant will walk on a treadmill.
Experimenteel: 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.
Apparaat: Spinal Stimulation
A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lumbar).
Andere namen:
  • SpineX
  • xStep
Ander: Treadmill Walking
Participant will walk on a treadmill.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Modified Tardieu Scale of Spasticity
Tijdsspanne: 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.
End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Step Length
Tijdsspanne: End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
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.
End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
Gait Deviation Index (GDI)
Tijdsspanne: Last 5 minutes of treadmill walking during visit relative to baseline at start of walking.
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.
Last 5 minutes of treadmill walking during visit relative to baseline at start of walking.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Washington

Medewerkers

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Onderzoekers

  • Hoofdonderzoeker: Katherine Steele, PHD, University of Washington
  • Hoofdonderzoeker: Heather Feldner, PhD, University of Washington

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

13 augustus 2026

Primaire voltooiing (Geschat)

1 juni 2028

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

25 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 september 2026

Eerst geplaatst (Werkelijk)

17 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 september 2026

Laatste update ingediend die voldeed aan QC-criteria

14 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY00014877-A
  • R21HD121135 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

IPD will be made available 6 months following publication of study results.

IPD-toegangscriteria voor delen

Direct access with registration on NIH repository.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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