Overview
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.
Description
- OBJECTIVES
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- 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.
Eligibility
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)