Noninvasive Spinal Stimulation in Stroke (NCT03714282) | Clinical Trial Compass
CompletedNot Applicable
Noninvasive Spinal Stimulation in Stroke
United States8 participantsStarted 2018-10-18
Plain-language summary
This is a randomized control trial that will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Healthy Control Group Inclusion Criteria:
* Age 18 or older
* Able and willing to give written consent and comply with study procedures
Healthy Control Group Exclusion Criteria:
* No history of cerebrovascular accidents or neurological degenerative pathologies (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
* Pregnant or nursing
* Skin allergies or irritation; open wounds
* Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD)
Stroke Group Inclusion Criteria:
* Participants are 18 years of age or older
* Participants are at least 4 weeks post stroke
* Participants with hemiplegia secondary to a single stroke
* Functional Ambulation Category of 2 or greater - Patient needs continuous or intermittent support of one person to help with balance and coordination.
* Participants are able to provide informed consent
* Participants are not currently receiving regular physical therapy services
Stroke Group Exclusion Criteria:
* Individuals less than18 years of age
* Individuals less than 4 weeks post stroke
* Individuals with ataxia
* Individuals with multiple stroke history
* Currently taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Tricyclic antidepressant (TCA)
* Botox injection in lower extremity within the last 4 months
* Modified Ashworth score of 3 or greater in lower extremity
* Pregnancy or nursing
* Pacemaker or anti-spasticity implantable pumps
* Active…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Step-length Symmetry Using Symmetry Index
Timeframe: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)
2
Change in Swing-time Symmetry
Timeframe: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)