Transcutaneous Stimulation for Neurological Populations

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT04467437
Status
Recruiting
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Conditions

  • Cerebral Palsy
  • Neurological Disorder

Eligibility Criteria

Sex
ALL
Age
4 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Gait Training — OTHER
    Training that targets rehabilitation of walking function
  • Transcutaneous Spinal Stimulation — DEVICE
    Non-invasive electrical stimulation of the spinal cord over the skin combined with gait training

Study Details

The purpose of the study is to evaluate whether non-invasive stimulation over the spinal cord at the neck and/or lower back can improve walking function for people with neurologic conditions. Spinal stimulation has been used extensively for individuals with spinal cord injury, and has demonstrated improvements in function. This study will extend this work to other neurologic conditions, such as cerebral palsy and stroke, that also demonstrate similar impairments as spinal cord injury. The primary aims of this study are to: Aim 1: Evaluate impact of spinal stimulation on spasticity and locomotor function. Aim 2: Investigate participant perceptions of spinal stimulation. The investigators will be using a cross-over design study to compare intensive training only to intensive training combined with spinal stimulation. After an initial baseline period of up to 4 weeks (Phase I). Participants will have their first intervention phase of the study (Phase II). This will involve either intensive training only (Condition A) or intensive training combined with spinal stimulation (Condition B). This will be followed by a washout period with no intervention (Phase III) and then the second intervention phase (Phase IV). The second intervention phase will involve either Condition A or Condition B, whichever the participants did not received during Phase II. Phases II-IV will each last up to 8 weeks. After the intervention period is complete, the participant will be asked to come for follow-up visits up to 3 months after the intervention phases are completed (Phase V).

Key Dates

Start date
Jan 1, 2021
Status verified
Sep 2024
Primary completion
Aug 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intensive Training Only
    Physical and gait training that targets rehabilitation of walking function.
  • Active Comparator: Intensive Training Combined with Spinal Stimulation
    Transcutaneous spinal stimulation combined with physical and gait training that targets rehabilitation of walking function.

Primary Outcome Measure

Change from baseline - Six Minute Walk Test [ Time Frame: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98115
Siddhi R Shrivastav
[email protected]
Chet T Moritz
[email protected]
Chet T Moritz, PhD (PRINCIPAL_INVESTIGATOR)
Katherine M Steele, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Washington· Seattle, WA

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