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

Sponsored by Shirley Ryan AbilityLab

About this study

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.

OBJECTIVES: * Exploratory phase: Identify a systematic, methodical approach to identifying the optimal stimulation parameters and gait training protocol for each individual patient with stroke. * Aim 1: Evaluate short-term effects of transcutaneous spinal cord stimulation + gait training on gait symmetry, gait performance, and corticospinal circuitry in individuals with chronic stroke. * Aim 2: Evaluate and predict long-term effects of transcutaneous spinal cord stimulation + gait training on gait symmetry, gait performance, and corticospinal circuitry in individuals with chronic stroke * Aim 3: Identify parameters that distinguish responders from non-responders to transcutaneous spinal cord stimulation in individuals with chronic stroke.

Where this study is enrolling

Who can participate

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)

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.