Clinical trial NCT03714282: Noninvasive Spinal Stimulation in Stroke
Official title: Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Spinal cord stimulation
electrical stimulation
locomotion
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2018-10-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: Healthy Control Group 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

Primary outcomes:
measure: Change in Gait Symmetry
timeFrame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Secondary outcomes:
measure: Change in 10 Meter Walk Test
timeFrame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
measure: Change in 6 Minute Walk Test Using VO2 Analysis
timeFrame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
measure: 4. Locomotion assessment for intra limb coordination using electromyography (EMG) on GaitRite
timeFrame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
measure: Change in Spinal Motor Evoked Potentials (MEPs)
timeFrame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
measure: Change corticospinal excitability
timeFrame: Baseline, Post intervention
measure: Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
timeFrame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
measure: Change in Stroke Impact Scale-16
timeFrame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
measure: Change Static in Balance
timeFrame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Other outcomes:
measure: Change in Gait Symmetry on Treadmill
timeFrame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
measure: Change in Dynamic Balance
timeFrame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: