Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
NCT ID: NCT05167786
Last Updated: 2025-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
115 participants
INTERVENTIONAL
2022-03-01
2027-08-25
Brief Summary
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Detailed Description
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* Exploratory phase: Identify a systematic, methodical approach to identifying the optimal stimulation parameters and gait training protocol for each individual patient with stroke.
* Aim 1: Evaluate short-term effects of transcutaneous spinal cord stimulation + gait training on gait symmetry, gait performance, and corticospinal circuitry in individuals with chronic stroke.
* Aim 2: Evaluate and predict long-term effects of transcutaneous spinal cord stimulation + gait training on gait symmetry, gait performance, and corticospinal circuitry in individuals with chronic stroke
* Aim 3: Identify parameters that distinguish responders from non-responders to transcutaneous spinal cord stimulation in individuals with chronic stroke.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Aim 1: Gait Training + Stimulation
Up to 60 min of locomotion training with 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.
Noninvasive spinal stimulation with gait training
Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform lower limb locomotor activities.
Exploratory 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.
Aim 1: Gait Training + Sham Stimulation
Up to 30 seconds of transcutaneous spinal cord stimulation in order to blind them to the intervention while performing locomotion training. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.
Conventional 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.
Aim 2: Gait Training + Stimulation
Up to 60 min of locomotion training with 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.
Noninvasive spinal stimulation with gait training
Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform lower limb locomotor activities.
Exploratory 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.
Aim 2: Gait Training + Sham Stimulation
Up to 30 seconds of transcutaneous spinal cord stimulation in order to blind them to the intervention while performing locomotion training. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.
Conventional 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.
Interventions
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Noninvasive spinal stimulation with gait training
Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform lower limb locomotor activities.
Conventional 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.
Exploratory 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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
18 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
Shirley Ryan AbilityLab
OTHER
Responsible Party
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Arun Jayaraman, PT, PhD
Principal Investigator
Principal Investigators
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Arun Jayaraman, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU00215009
Identifier Type: -
Identifier Source: org_study_id
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