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Transcutaneous Spinal Stimulation for Neurological Conditions

This study is testing if a non-invasive treatment called Transcutaneous Spinal Stimulation can improve walking for people with neurological conditions like cerebral palsy. This treatment involves placing electrodes on the skin over your neck or lower back to stimulate the spinal cord, combined with gait training (walking exercises). Researchers want to see if this stimulation helps with walking function, measured by how far you can walk in six minutes and how fast you can walk ten meters. They also want to understand participants' experiences with the stimulation. You might be able to join if you are 4 to 70 years old, can walk at least 20 yards, and can attend up to five physical therapy sessions per week. The study plans to enroll 20 participants.

Study design
This interventional study aims to enroll 20 participants to evaluate the effects of Transcutaneous Spinal Stimulation combined with gait training.
What's involved
You would participate in physical therapy sessions and testing activities up to five times per week. Your walking function will be measured at the start and every two weeks throughout the study, for an average of 10 months.
Compensation
Not stated in the trial record.
Follow-up
Your walking function will be measured for an average of 10 months, with measurements taken every two weeks.

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NCT04467437

Transcutaneous Stimulation for Neurological Populations

Recruiting
NAAges 4–70InterventionalTreatment
University of Washington
~20 participants
Updated 2024-09-19 on ClinicalTrials.gov
What's tested:Gait TrainingTranscutaneous Spinal Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline - Six Minute Walk Test
Measured over Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
+1 more outcome measured

Conditions

Neurological Disorder
Cerebral Palsy

Explore related trials

Cerebral PalsyNervous System DisorderStroke

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Katherine M Steele, PhD · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

Siddhi R Shrivastav, BPTh, MS
[email protected]
973-444-1940
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change from baseline - Six Minute Walk TestMeasurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.

    Measure of walking ability. The distance is reported in meters.

  • Change from baseline - Ten Meter Walk TestMeasurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.

    The measure of walking ability at fast and self-selected speeds. The walking speed is reported as meters per second.