Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke

Launched by SHIRLEY RYAN ABILITYLAB · Dec 21, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called transcutaneous spinal cord stimulation, which is a non-invasive method that uses electrical signals to help improve walking and balance in individuals who have hemiplegia due to a stroke. The goal is to see how effective this treatment is for people who have difficulty moving one side of their body after a stroke.

To participate in this trial, individuals need to be at least 18 years old and should have had their stroke at least six months prior. They should be able to walk with some support but not be currently receiving regular physical therapy. There are some health conditions that could prevent someone from joining, such as having multiple strokes, certain neurological issues, or using specific medical devices. Participants in the trial can expect to receive the treatment and be monitored closely for changes in their ability to walk and maintain balance, helping researchers understand if this approach can be beneficial for others in the future.

Gender

ALL

Eligibility criteria

• • Inclusion 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
• • Exclusion Criteria
• • 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 participate in this component of the studies.
• • 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)