Transcutaneous Stimulation for Neurological Populations

  • STATUS
    Recruiting
  • days left to enroll
    78
  • participants needed
    20
  • sponsor
    University of Washington
Updated on 19 February 2024
stroke
spinal cord
cerebral palsy
spasticity
gait training
transcutaneous stimulation

Summary

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).

Details
Condition Cerebral Palsy, Cerebral Palsy, nervous system disorder, neurologic disorders, neurologic disorders
Age 10-70 years
Treatment Gait training, Transcutaneous Spinal Stimulation
Clinical Study IdentifierNCT04467437
SponsorUniversity of Washington
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

have a neurologic condition
can walk 20 yards, with or without an assistive device
have stable medical condition
are capable of performing simple cued motor tasks and who can follow 2-3 step commands
have ability to attend up to 5 sessions per week physical therapy sessions and testing activities
have adequate social support to be able to participate in training and assessment sessions, up to 5 sessions per week, for the duration of up to 11 months within the study period
who are volunteering to be involved in this study
can read and speak English

Exclusion Criteria

have significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation
have cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
have a history of uncontrolled seizures
have unhealed fracture or other musculoskeletal impairment that might interfere with lower extremity rehabilitation or testing activities
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 history of orthopedic surgery in lower extremities or neurosurgery that may be a confounding factor for interpretation of the results (such as tendon transfer, tendon or muscle lengthening for spasticity management, injection therapies to lower extremity muscles, etc.) in last 12 months
have established osteoporosis and taking medication for osteoporosis treatment
have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
have active cancer
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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