Noninvasive Spinal Stimulation in Stroke

Shirley Ryan AbilityLab

Status: Enrolling

Conditions: Stroke

Treatments: Device: Noninvasive spinal stimulation with gait training; Device: Conventional gait training; Other: Healthy control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03714282

STU00206430

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Noninvasive Spinal Stimulation with Gait Training

Experimental group

Description:

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.

Treatment:

Device: Noninvasive spinal stimulation with gait training

Conventional Gait Training

Active Comparator group

Description:

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.

Treatment:

Device: Conventional gait training

Healthy Control Group

Other group

Description:

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

Treatment:

Other: Healthy control group