Noninvasive spinal stimulation to improve walking in stroke patients
Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
This study is testing if using a noninvasive spinal stimulation along with walking training can help stroke patients improve their walking and balance better than just walking training alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT03714282 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of noninvasive transcutaneous spinal cord stimulation combined with ambulation training for individuals with chronic hemiplegia due to stroke. The study aims to assess improvements in gait, balance, and overall locomotor function, as well as the symmetry of gait and standing posture. Participants will be randomized into groups receiving either the spinal stimulation with gait training or conventional gait training alone. The trial will also include a healthy control group for comparison.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are at least 4 weeks post-stroke and have hemiplegia from a single stroke.
Not a fit: Patients who are currently receiving regular physical therapy or have multiple strokes or other neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance mobility and quality of life for stroke survivors with hemiplegia.
How similar studies have performed: Other studies have shown promise with similar noninvasive spinal stimulation techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Arun Jayaraman, PT, PhD — Shirley Ryan AbilityLab
- Study coordinator: Kelly McKenzie, DPT
- Email: kaskins@sralab.org
- Phone: 312-238-7111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.