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New treatment option for Stroke
Official title Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
ClinicalTrials.gov ID: NCT05167786
What this study is testing
- What it's testing
- This study has two interventional components, the first is a cross-over design and the second is a randomized control trial. Both will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older
- Able and willing to give written consent and comply with study procedures
- At least 6 months' post-stroke
- Hemiplegia secondary to a single stroke
- Functional Ambulation Category of 2 or greater - i.e., subject needs continuous or intermittent support of one person to help with balance and...
You likely can't join if
- Ataxia
- Multiple stroke history
- Botox injection in lower extremity within the last 4 months
- Modified Ashworth score of 3 or greater in lower extremity
- Pregnant or nursing
- Using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD) or anti-spasticity...
See the full eligibility criteria
- Age 18 years or older
- Able and willing to give written consent and comply with study procedures
- At least 6 months' post-stroke
- Hemiplegia secondary to a single stroke
- Functional Ambulation Category of 2 or greater - i.e., subject needs continuous or intermittent support of one person to help with balance and coordination.
- Not currently receiving regular physical therapy services
- Physician approval to participate
- Ataxia
- Multiple stroke history
- Botox injection in lower extremity within the last 4 months
- Modified Ashworth score of 3 or greater in lower extremity
- Pregnant or nursing
- Using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD) or anti-spasticity implantable pumps
- Active pressure sores
- Unhealed bone fractures
- Peripheral neuropathies
- Painful musculoskeletal dysfunction due to active injuries or infections
- Severe contractures in the lower extremities
- Medical illness limiting the ability to walk
- Active urinary tract infection
- Clinically significant depression, psychiatric disorders, or ongoing drug abuse
- Active cancer or cancer in remission less than 5 years
- Orthopedic dysfunction, injury, or surgery that would impact an individual's ability to use the lower extremity.
- Traumatic brain injury or other neurological conditions that would impact the study. TMS-Specific Exclusion Criteria: TMS will be utilized for both Aims. The sub-set of participants who meet these criteria will...
- Medicated with agents known to increase (e.g., amphetamines) or decrease motor system excitability (e.g., lorazepam)
- Implanted cardiac pacemaker
- Metal implants in the head or face
- Suffers unexplained, recurring headaches
- Had a seizure in the past unrelated to the stroke event, or has epilepsy
- Skull abnormalities or fractures
- A concussion within the last 6 months
- Unstable cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension, uncontrolled diabetes, or chronic emphysema)
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.