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Noninvasive Spinal Stimulation in Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Noninvasive spinal stimulation with gait training
Conventional gait training
Healthy control group
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Spinal cord stimulation, electrical stimulation, locomotion

Eligibility Criteria

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

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

Sites / Locations

  • Shirley Ryan AbilityLabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Noninvasive Spinal Stimulation with Gait Training

Conventional Gait Training

Healthy Control Group

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

Change in Gait Symmetry
Participants will ambulate along Gait Rite electronic walkway up to 12 times (3 times per gait speed with and without lower extremity orthotics) to evaluate baseline 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 10 Meter Walk Test
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe 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). The test will be recorded up to 12 times (3 times at each gait speed with and without lower extremity orthotics if safe and appropriate).
Change in 6 Minute Walk Test Using VO2 Analysis
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.
4. Locomotion assessment for intra limb coordination using electromyography (EMG) on GaitRite
Locomotion assessment for inter and intra limb coordination using wearable sensors and EMG sensors. Participants ambulate along Gait Rite electronic walkway up to 12 times (3 times at each gait speed with and without lower extremity orthotics if safe and appropriate) to evaluate gait pattern and lower extremity muscle activity at both self-selected and fast but safe gait speed. The sensors used will include those available from the BioStampRC Discovery Kit (MC10,Inc.), EMG sensors and custom sensors designed by the John Rogers research group at Northwestern University. The wearable sensors will collect the following information: Biometric data, including electrocardiography (EKG) and electromyography(EMG). Movement data from the limbs including signals from triaxial accelerometers (ACC) and gyroscopes (GYR). The rate of sweating and glucose concentration using microfluidic sweat sensor.
Change in Spinal Motor Evoked Potentials (MEPs)
Spinal Motor Evoked Potentials (MEPs) will be obtained by stimulating between the spinous processes of up to 5 vertebrae with a single pulse. MEPs are the electromyograph responses of the peripheral muscles to electrical stimulation of the spinal cord. MEPs will be used to test the integrity of the motor pathways of the spinal cord. A Transcutaneous Spinal Cord Neurostimulator (BioStim-5 or NeuroEnabling Stimulator System) will deliver transcutaneous electrical spinal cord stimulation.
Change corticospinal excitability
Transcranial magnetic stimulation (TMS) will be used to assess changes in corticospinal excitability that may occur following repeated transcutaneous spinal stimulation and ambulation training. TMS is a safe, non-invasive, painless method of brain stimulation that widely used to study the physiology of the representations of muscles in the motor cortex in healthy and neurologically disordered individuals. Very short duration (< 1 ms) magnetic pulses are applied via an insulated wire coil placed on the intact scalp overlaying the motor cortical area projecting to a target muscle. Each pulse induces a motor evoked potential (MEP) in a target muscle that can be readily monitored by recording Electromyogram EMG from that muscle.
Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
The purpose of the FMA is to evaluate and measure recovery in post-stroke hemiplegic patients. There are five domains assessed on a 3 point ordinal scale from 0-2. "0" is equal to "cannot perform", "1" is equal to "performs partially", and "2" is equal to "performs fully. The domains for upper and lower extremity motor function will be used.
Change in Stroke Impact Scale-16
Stroke Impact Scale-16 completed by patient to evaluate the impact of the stroke on the person's health and life from the individuals perspective. It is scored from 1-5, 1 signifying a major effect on the individual and 5 signifying little to no effect.
Change Static in Balance
During the static stability test, the participants will be instructed to stand on the force plate as still as possible for up to 60 seconds with their eyes open. After rest, the task will be repeated with the eyes closed. The excursions of the center of pressure (COP) and EMG of leg muscles will be analyzed. The AMTI Force System from Water Town, MA will be used to assess balance.

Full Information

First Posted
September 25, 2018
Last Updated
August 31, 2020
Sponsor
Shirley Ryan AbilityLab
Collaborators
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03714282
Brief Title
Noninvasive Spinal Stimulation in 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
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2022 (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 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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Spinal cord stimulation, electrical stimulation, locomotion

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Noninvasive Spinal Stimulation with Gait Training
Arm Type
Experimental
Arm 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.
Arm Title
Conventional Gait Training
Arm Type
Active Comparator
Arm 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.
Arm Title
Healthy Control Group
Arm Type
Other
Arm 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
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 locomotor activities.
Intervention Type
Device
Intervention Name(s)
Conventional gait training
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Healthy control group
Intervention 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
Primary Outcome Measure Information:
Title
Change in Gait Symmetry
Description
Participants will ambulate along Gait Rite electronic walkway up to 12 times (3 times per gait speed with and without lower extremity orthotics) to evaluate baseline 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
Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Secondary Outcome Measure Information:
Title
Change in 10 Meter Walk Test
Description
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe 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). The test will be recorded up to 12 times (3 times at each gait speed with and without lower extremity orthotics if safe and appropriate).
Time Frame
Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Title
Change in 6 Minute Walk Test Using VO2 Analysis
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
Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Title
4. Locomotion assessment for intra limb coordination using electromyography (EMG) on GaitRite
Description
Locomotion assessment for inter and intra limb coordination using wearable sensors and EMG sensors. Participants ambulate along Gait Rite electronic walkway up to 12 times (3 times at each gait speed with and without lower extremity orthotics if safe and appropriate) to evaluate gait pattern and lower extremity muscle activity at both self-selected and fast but safe gait speed. The sensors used will include those available from the BioStampRC Discovery Kit (MC10,Inc.), EMG sensors and custom sensors designed by the John Rogers research group at Northwestern University. The wearable sensors will collect the following information: Biometric data, including electrocardiography (EKG) and electromyography(EMG). Movement data from the limbs including signals from triaxial accelerometers (ACC) and gyroscopes (GYR). The rate of sweating and glucose concentration using microfluidic sweat sensor.
Time Frame
Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Title
Change in Spinal Motor Evoked Potentials (MEPs)
Description
Spinal Motor Evoked Potentials (MEPs) will be obtained by stimulating between the spinous processes of up to 5 vertebrae with a single pulse. MEPs are the electromyograph responses of the peripheral muscles to electrical stimulation of the spinal cord. MEPs will be used to test the integrity of the motor pathways of the spinal cord. A Transcutaneous Spinal Cord Neurostimulator (BioStim-5 or NeuroEnabling Stimulator System) will deliver transcutaneous electrical spinal cord stimulation.
Time Frame
Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Title
Change corticospinal excitability
Description
Transcranial magnetic stimulation (TMS) will be used to assess changes in corticospinal excitability that may occur following repeated transcutaneous spinal stimulation and ambulation training. TMS is a safe, non-invasive, painless method of brain stimulation that widely used to study the physiology of the representations of muscles in the motor cortex in healthy and neurologically disordered individuals. Very short duration (< 1 ms) magnetic pulses are applied via an insulated wire coil placed on the intact scalp overlaying the motor cortical area projecting to a target muscle. Each pulse induces a motor evoked potential (MEP) in a target muscle that can be readily monitored by recording Electromyogram EMG from that muscle.
Time Frame
Baseline, Post intervention
Title
Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
Description
The purpose of the FMA is to evaluate and measure recovery in post-stroke hemiplegic patients. There are five domains assessed on a 3 point ordinal scale from 0-2. "0" is equal to "cannot perform", "1" is equal to "performs partially", and "2" is equal to "performs fully. The domains for upper and lower extremity motor function will be used.
Time Frame
Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Title
Change in Stroke Impact Scale-16
Description
Stroke Impact Scale-16 completed by patient to evaluate the impact of the stroke on the person's health and life from the individuals perspective. It is scored from 1-5, 1 signifying a major effect on the individual and 5 signifying little to no effect.
Time Frame
Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Title
Change Static in Balance
Description
During the static stability test, the participants will be instructed to stand on the force plate as still as possible for up to 60 seconds with their eyes open. After rest, the task will be repeated with the eyes closed. The excursions of the center of pressure (COP) and EMG of leg muscles will be analyzed. The AMTI Force System from Water Town, MA will be used to assess balance.
Time Frame
Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Other Pre-specified Outcome Measures:
Title
Change in Gait Symmetry on Treadmill
Description
Participants will ambulate on the treadmill for up to 10 minutes in order to obtain spatiotemporal measures of gait and to obtain gait kinematics during treadmill locomotion
Time Frame
Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Title
Change in Dynamic Balance
Description
During the dynamic stability test, the ability to voluntarily displace the COP to a maximum distance without losing balance will be assessed (Limits of stability (LOS) test). The participant will be instructed to lean forward, backward, left, and right, hold the position for ~5 seconds and return back to the initial/center position. The AMTI Force System from Water Town, MA will be used to assess balance.
Time Frame
Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly McKenzie, DPT
Phone
312-238-7111
Email
kaskins@sralab.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lori l McGee, BS, OT
Phone
312-238-2091
Email
lmcgee@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
Lori McGee Koch
Phone
312-238-2091
Email
lmkoch@ricres.org
First Name & Middle Initial & Last Name & Degree
Kristen Hohl
Phone
312-238-2640
First Name & Middle Initial & Last Name & Degree
Arun Jayaraman, PT,PhD

12. IPD Sharing Statement

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Noninvasive Spinal Stimulation in Stroke

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