RecruitingNot ApplicableNCT05167786

Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke

Sponsor

Shirley Ryan AbilityLab

Enrollment

115 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

Stroke

Summary

This study has two interventional components, the first is a cross-over design and the second is a randomized control trial. Both will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Age 18 years or older
Able and willing to give written consent and comply with study procedures
At least 6 months' post-stroke
Hemiplegia secondary to a single stroke
Functional Ambulation Category of 2 or greater - i.e., subject needs continuous or intermittent support of one person to help with balance and coordination.
Not currently receiving regular physical therapy services
Physician approval to participate

Exclusion Criteria25

Ataxia
Multiple stroke history
Botox injection in lower extremity within the last 4 months
Modified Ashworth score of 3 or greater in lower extremity
Pregnant or nursing
Using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD) 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
Active cancer or cancer in remission less than 5 years
Orthopedic dysfunction, injury, or surgery that would impact an individual's ability to use the lower extremity.
Traumatic brain injury or other neurological conditions that would impact the study.
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
A concussion within the last 6 months
Unstable cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension, uncontrolled diabetes, or chronic emphysema)

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Interventions

DEVICENoninvasive spinal stimulation with gait training

Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform lower limb locomotor activities.

DEVICEConventional gait training

Subjects will receive lower limb locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.

OTHERExploratory Phase - Optimization of Gait Training and Spinal Stimulation

Subjects may receive various lower limb locomotion training with or without transcutaneous spinal cord stimulation. Training approaches may include but are not limited to single or split belt treadmill and over ground walking. Transcutaneous Spinal Cord Neurostimulator may deliver a variety of transcutaneous electrical spinal cord stimulation to subjects.