N/A N=8 Randomized Treatment

Noninvasive Spinal Stimulation in Stroke

Stroke

Bottom Line

View on ClinicalTrials.gov: NCT03714282 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Change in Step-length Symmetry Using Symmetry Index — 72.2; 75.8; 92.2; 76.0 Symmetry Index

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Noninvasive spinal stimulation with gait training (Device); Conventional gait training (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Shirley Ryan AbilityLab
Primary completion: May 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Step-length Symmetry Using Symmetry Index	72.2; 75.8; 92.2; 76.0	—
PRIMARY Change in Swing-time Symmetry	57.9; 57.8; 67.8; 57.7	—
SECONDARY Change in 10 Meter Walk Test - Self-selected Velocity	0.65; 0.68; 0.82; 0.76	—
SECONDARY Change in 10 Meter Walk Test - Fast Velocity	0.81; 0.91; 1.14; 0.96	—
SECONDARY Change in 6 Minute Walk Test	205.1; 246.2; 266.6; 272.0	—
SECONDARY Change in PCI During 6 Minute Walk Test	1.13; 1.22; 0.91; 0.99	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03714282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.