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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Noninvasive spinal stimulation with gait training
Noninvasive spinal stimulation
Conventional gait training
Sham
Exploratory Phase - Optimization of Gait Training and Spinal Stimulation
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • 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 Criteria

  • 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.

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.

  • 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)

Sites / Locations

  • Shirley Ryan AbilityLabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Active Comparator

Sham Comparator

Experimental

Active Comparator

Arm Label

Aim 1: Gait Training + Stimulation

Aim 1: Stimulation Only

Aim 1: Gait Training + Sham Stimulation

Aim 1: Sham Only

Aim 2: Gait Training + Stimulation

Aim 2: Gait Training + Sham Stimulation

Arm Description

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.

Up to 60 minutes of transcutaneous spinal cord stimulation while resting in a comfortable position.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Gait Symmetry
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
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
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).

Full Information

First Posted
December 7, 2021
Last Updated
September 9, 2022
Sponsor
Shirley Ryan AbilityLab
Collaborators
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05167786
Brief Title
Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
Official Title
Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
August 25, 2026 (Anticipated)
Study Completion Date
August 25, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. 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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aim 1: Gait Training + Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Aim 1: Stimulation Only
Arm Type
Active Comparator
Arm Description
Up to 60 minutes of transcutaneous spinal cord stimulation while resting in a comfortable position.
Arm Title
Aim 1: Gait Training + Sham Stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Aim 1: Sham Only
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Aim 2: Gait Training + Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Aim 2: Gait Training + Sham Stimulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Noninvasive spinal stimulation with gait training
Intervention Description
Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform lower limb locomotor activities.
Intervention Type
Device
Intervention Name(s)
Noninvasive spinal stimulation
Intervention Description
Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation to subjects.
Intervention Type
Device
Intervention Name(s)
Conventional gait training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Subject will not receive either transcutaneous electrical spinal cord stimulation or perform lower limb locomotor activities.
Intervention Type
Other
Intervention Name(s)
Exploratory Phase - Optimization of Gait Training and Spinal Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Gait Symmetry
Description
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.
Time Frame
Aim 1: Baseline pre-intervention immediately post intervention for interventions 1, 2, 3 and 4. Aim 2: Baseline pre-intervention, 4 weeks into the intervention, immediately post intervention and 3 months post intervention for intervention 1 and 2.
Secondary Outcome Measure Information:
Title
Change in 6 Minute Walk Test
Description
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.
Time Frame
Aim 2: Baseline pre-intervention, 4 weeks into the intervention, immediately post intervention and 3 months post intervention for intervention 1 and 2.
Title
Change in 10 Meter Walk Test
Description
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).
Time Frame
Aim 1: Baseline pre-intervention immediately post intervention for interventions 1, 2, 3 and 4. Aim 2: Baseline pre-intervention, 4 weeks into the intervention, immediately post intervention and 3 months post intervention for intervention 1 and 2.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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 Criteria 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. 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. 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly McKenzie, DPT
Phone
312-238-7111
Email
kmckenzie@sralab.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Prokup, DPT
Phone
3122381355
Email
sprokup@sralab.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arun Jayaraman, PT, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly McKenzie, DPT
Phone
312-238-7111
Email
kmckenzie@sralab.org
First Name & Middle Initial & Last Name & Degree
Shreya Aalla, BS
Phone
312-238-7323
Email
saalla@sralab.org

12. IPD Sharing Statement

Learn more about this trial

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

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