Noninvasive Spinal Stimulation in Stroke
Purpose
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.
Condition
- Stroke
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 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 - Metal implants in their spine TMS Specific Criteria (see Safety Screening Questionnaire for Transcranial Magnetic Stimulation) - 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 - Suffered a concussion within the last 6 month - Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema) - Pregnant
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Noninvasive Spinal Stimulation with Gait Training |
May receive up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. |
|
|
Active Comparator Conventional Gait Training |
May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. |
|
|
Other Healthy Control Group |
Participant in the Healthy Control Group will participate in up to 3 assessment sessions in order to obtain comparative data for Spinal Motor Evoked Potentials (MEPs), lower extremity MVC's, sidelying EMG data and overground EMG data |
|
Recruiting Locations
Shirley Ryan AbilityLab
Chicago 4887398, Illinois 4896861 60611
Chicago 4887398, Illinois 4896861 60611
More Details
- Status
- Recruiting
- Sponsor
- Shirley Ryan AbilityLab
Detailed Description
OBJECTIVES: - To determine whether transcutaneous spinal cord stimulation combined with ambulation training modulates corticospinal locomotor networks in individuals with chronic hemiplegic stroke - To determine whether transcutaneous spinal stimulation combined with ambulation training improves locomotor function in individuals with chronic hemiplegic stroke - To determine whether transcutaneous spinal stimulation combined with ambulation training improves symmetry of gait in individuals with chronic hemiplegic stroke - To determine whether transcutaneous spinal stimulation combined with ambulation training improves standing posture and balance in individuals with chronic hemiplegic stroke - To determine whether ambulation efficiency (improved cardiovascular conditioning) improves with transcutaneousnon-invasive spinal stimulation and locomotor training in individuals with chronic hemiplegic stroke