Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
OBJECTIVES:
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Exploratory phase: Identify a systematic, methodical approach to identifying the optimal stimulation parameters for each individual patient with stroke.
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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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: Noninvasive spinal stimulation with gait training
Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform lower limb locomotor activities.
|
| Active Comparator: Aim 1: Stimulation Only Up to 60 minutes of transcutaneous spinal cord stimulation while resting in a comfortable position. |
Device: Noninvasive spinal stimulation
Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation.
|
| Active Comparator: 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. |
Device: 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.
|
| Sham Comparator: Aim 1: Sham Only Up to 60 minutes of transcutaneous spinal cord stimulation while resting in a comfortable position during which they will receive up to 30 seconds of transcutaneous spinal cord stimulation in order to blind them to the intervention. |
Other: Sham
Subject will not receive either transcutaneous electrical spinal cord stimulation or perform lower limb locomotor activities.
|
| Experimental: 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. |
Device: Noninvasive spinal stimulation with gait training
Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform lower limb locomotor activities.
|
| Active Comparator: 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. |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- Change in Gait Symmetry [Baseline pre-intervention 1, immediately after intervention 1, baseline pre-intervention 2, immediately after intervention 2, baseline pre-intervention 3, immediately after intervention 3, baseline pre-intervention 4, immediately after intervention 4]
Participants will ambulate along Gait Rite electronic walkway 3 times per gait speed to evaluate gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway contains sensor pads encapsulated in a carpet and connected to a computer. The system can be laid over any flat surface and automates measuring temporal and spatial gait parameters. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality.
Secondary Outcome Measures
- Change in 6 Minute Walk Test [Baseline pre-intervention 1, immediately after intervention 1, baseline pre-intervention 2, immediately after intervention 2, baseline pre-intervention 3, immediately after intervention 3, baseline pre-intervention 4, immediately after intervention 4]
The 6 Minute Walk Test (6MWT) measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test will be used to determine participant's gait efficiency at baseline and at study completion. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test will be administered while wearing a portable gas analysis system called the Cosmed K4B2 to measure oxygen consumption. This system measures oxygen consumption (VO2) and Carbon-dioxide production (VCO2) in a breath by breath fashion.
- Change in 10 Meter Walk Test [Baseline pre-intervention 1, immediately after intervention 1, baseline pre-intervention 2, immediately after intervention 2, baseline pre-intervention 3, immediately after intervention 3, baseline pre-intervention 4, immediately after intervention 4]
This test will examine the patient's gait speed. Patients will be directed to walk 3 times per gait speed to evaluate gait pattern at both their self-selected and safe fast gait speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 years or older
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Able and willing to give written consent and comply with study procedures
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At least 6 months' post-stroke
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Hemiplegia secondary to a single stroke
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Functional Ambulation Category of 2 or greater - i.e., subject needs continuous or intermittent support of one person to help with balance and coordination.
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Not currently receiving regular physical therapy services
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Physician approval to participate
Exclusion Criteria:
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Ataxia
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Multiple stroke history
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Currently taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Tricyclic antidepressant (TCA)
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Botox injection in lower extremity within the last 4 months
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Modified Ashworth score of 3 or greater in lower extremity
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Pregnant or nursing
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Using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD) or anti-spasticity implantable pumps
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Active pressure sores
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Unhealed bone fractures
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Peripheral neuropathies
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Painful musculoskeletal dysfunction due to active injuries or infections
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Severe contractures in the lower extremities
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Medical illness limiting the ability to walk
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Active urinary tract infection
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Clinically significant depression, psychiatric disorders, or ongoing drug abuse
TMS-Specific Exclusion Criteria: TMS will be utilized for both Aims. The sub-set of participants who meet these criteria will participate in this component of the studies.
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Medicated with agents known to increase (e.g., amphetamines) or decrease motor system excitability (e.g., lorazepam)
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Implanted cardiac pacemaker
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Metal implants in the head or face
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Suffers unexplained, recurring headaches
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Had a seizure in the past unrelated to the stroke event, or has epilepsy
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Skull abnormalities or fractures
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A concussion within the last 6 months
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Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension, diabetes, or chronic emphysema)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shirley Ryan AbilityLab | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Shirley Ryan AbilityLab
- University of California, Los Angeles
Investigators
- Principal Investigator: Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU00215009