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Short-term Spinal Stimulation Effects in Cerebral Palsy

14. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Undersøgelse Kontakt Backup

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

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • Rekruttering
        • University of Washington
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: Spinal Stimulation
A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lumbar).
Andre navne:
  • SpineX
  • xStep
Andet: Treadmill Walking
Participant will walk on a treadmill.
Eksperimentel: 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.
Enhed: Spinal Stimulation
A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lumbar).
Andre navne:
  • SpineX
  • xStep
Andet: Treadmill Walking
Participant will walk on a treadmill.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Modified Tardieu Scale of Spasticity
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Step Length
Tidsramme: 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)
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Washington

Samarbejdspartnere

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

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. august 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

25. august 2026

Først indsendt, der opfyldte QC-kriterier

14. september 2026

Først opslået (Faktiske)

17. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00014877-A
  • R21HD121135 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

IPD-delingsadgangskriterier

Direct access with registration on NIH repository.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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