Noninvasive Spinal Stimulation in Stroke

Launched by SHIRLEY RYAN ABILITYLAB · Oct 18, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called noninvasive spinal cord stimulation to see if it can help improve walking and balance in people who have hemiplegia due to a stroke. Hemiplegia means that one side of the body is weak or paralyzed. The researchers are looking for participants who are at least 18 years old, have had a stroke at least four weeks ago, and can walk with some help. They want to understand if this treatment can make a difference in their daily lives.

To participate, individuals should not have serious health issues that could interfere with the study, like certain heart devices or conditions that affect movement. Participants will not be undergoing regular physical therapy during the trial, and they will need to provide informed consent, meaning they understand the study and agree to take part. Throughout the trial, participants can expect to receive careful monitoring and follow-up as researchers gather data on how the treatment affects their mobility and balance. This study is currently looking for volunteers, so it's a great opportunity for those who qualify and want to contribute to research that may help others in the future.

Gender

ALL

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