Actively Recruiting

Phase Not Applicable
Age: 4Years - 70Years
All Genders
NCT04467437

Transcutaneous Stimulation for Neurological Populations

Led by University of Washington · Updated on 2024-09-19

20

Participants Needed

1

Research Sites

360 weeks

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

S

Seattle Children's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Transcutaneous Stimulation for Neurological Populations

Who Can Participate

Age: 4Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a neurologic condition
  • Can walk 20 yards, with or without an assistive device
  • Have a stable medical condition
  • Are capable of performing simple cued motor tasks and can follow 2-3 step commands
  • Have the ability to attend up to 5 physical therapy sessions and testing activities per week
  • Have adequate social support to participate in training and assessments up to 5 sessions per week for up to 11 months
  • Are volunteering to participate in this study
  • Can read and speak English
Not Eligible

You will not qualify if you...

  • Have significant medical disease, including uncontrolled hypertension above 170/100 mmHg, cardiac or pulmonary disease, uncorrected coagulation problems, or need for therapeutic anticoagulation
  • Have cardiovascular or musculoskeletal disease or injury preventing full participation in physical therapy
  • Have a history of uncontrolled seizures
  • Have unhealed fractures or musculoskeletal issues interfering with lower extremity rehabilitation or testing
  • Are dependent on ventilation support
  • Have implanted stimulators (e.g., epidural, vagus nerve, pacemaker, cochlear) or drug delivery devices (e.g., baclofen pump)
  • Have had orthopedic or neurosurgery affecting results in the lower extremities within the past 12 months
  • Have established osteoporosis and are taking medication for it
  • Have rheumatic diseases such as rheumatoid arthritis or lupus
  • Have active cancer

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Washington

Seattle, Washington, United States, 98115

Actively Recruiting

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Research Team

S

Siddhi R Shrivastav, BPTh, MS

CONTACT

C

Chet T Moritz, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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