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Noninvasive Spinal Stimulation in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03922802
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab

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 after spinal cord injury.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Spinal Cord Diseases Device: Noninvasive Spinal Stimulation with Gait Training Other: Conventional Gait Training Not Applicable

Detailed Description:

OBJECTIVES:

  • To determine whether transcutaneous spinal cord stimulation combined with ambulation training modulates corticospinal locomotor networks in individuals with spinal cord injury
  • To determine whether transcutaneous spinal stimulation combined with ambulation training improves locomotor function in individuals with spinal cord injury
  • To determine whether transcutaneous spinal stimulation combined with ambulation training improves symmetry of gait in individuals with spinal cord injury
  • To determine whether transcutaneous spinal stimulation combined with ambulation training improves standing posture and balance in individuals with spinal cord injury
  • To determine whether ambulation efficiency (improved cardiovascular conditioning) improves with transcutaneous spinal stimulation and locomotor training in individuals with spinal cord injury

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation With Gait Therapy Versus Traditional Gait Therapy in Individuals With Spinal Cord Injury
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Noninvasive Spinal Stimulation with Gait Training

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.

Intervention: Device: Noninvasive spinal stimulation with gait training

Device: Noninvasive Spinal Stimulation with Gait Training
Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform locomotor activities.

Active Comparator: Conventional Gait Training
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.
Other: Conventional Gait Training
Subjects will perform locomotor activities without transcutaneous electrical spinal cord stimulation




Primary Outcome Measures :
  1. Change in Gait Kinematics [ Time Frame: Session 1 (baseline test, initial visit), Session 16 (Midpoint, 4 weeks), Session 30 (Post intervention, week 8), Session 33 (3 month follow-up), Session 35 (6 month follow-up), Session 37 (12 month follow-up) ]
    Participants will ambulate along Gait Rite electronic walkway 6 times (3 times per gait speed) 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 :
  1. Change in 10 Meter Walk Test [ Time Frame: Session 1 (baseline test, initial visit), Session 16 (Midpoint, 4 weeks), Session 30 (Post intervention, week 8), Session 33 (3 month follow-up), Session 35 (6 month follow-up), Session 37 (12 month follow-up) ]
    This test will examine the patient's gait speed. Patients will be directed to walk at their preferred maximum but safe speed.

  2. Change in 6 Minute Walk Test Using VO2 Analysis [ Time Frame: Session 1 (baseline test, initial visit), Session 16 (Midpoint, 4 weeks), Session 30 (Post intervention, week 8), Session 33 (3 month follow-up), Session 35 (6 month follow-up), Session 37 (12 month follow-up) ]
    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 assertive 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants have been diagnosed with a spinal cord injury below level C2/C3
  • AISA Impairment Scale Grade A-D
  • Participants are 18 years of age or older
  • Participants are at least 4 weeks post spinal cord injury
  • Participants with paraplegia or tetraplegia secondary to a single spinal cord injury
  • Participants are able to provide informed consent
  • Participants are not currently receiving regular physical therapy services

Exclusion Criteria:

  • Individuals less than 18 years of age
  • Individuals less than 4 weeks post spinal cord injury
  • Individuals with ataxia
  • Individuals with multiple spinal cord injury history
  • 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
  • Cardiopulmonary disease
  • Active urinary tract infection
  • Clinically significant depression, psychiatric disorders, or ongoing drug abuse
  • TMS Specific Exclusion 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 at any time in the past, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922802


Contacts
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Contact: Kelly A McKenzie, PT, DPT, NCS 312-238-7111 kmckenzie@sralab.org
Contact: Lindsey Yingling, PT, DPT, NCS 312-238-1063 lyingling@sralab.org

Locations
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United States, Illinois
Shirley Ryan AbilityLab Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Kelly A McKenzie, PT, DPT, NCS         
Principal Investigator: Arun Jayaraman, PT, PhD         
Sponsors and Collaborators
Shirley Ryan AbilityLab
University of California, Los Angeles
Investigators
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Principal Investigator: Arun Jayaraman, PT, PhD Shirley Ryan AbilityLab

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Responsible Party: Arun Jayaraman, PT, PhD, Director Max Nader Laboratory, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT03922802     History of Changes
Other Study ID Numbers: STU00208608
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab:
Spinal Cord Injury
Stimulation
Spinal Stimulation
Noninvasive stimulation

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System