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Completed

NCT Number: NCT03714282

Noninvasive Spinal Stimulation in Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

About this study

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 transcutaneous non-invasive spinal stimulation and locomotor training in individuals with chronic hemiplegic stroke

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noninvasive spinal stimulation with gait training

Device

Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform locomotor activities.

Conventional gait training

Device

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.

Primary outcomes

  1. Change in Step-length Symmetry Using Symmetry Index

    Time frame: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)

    Participants will ambulate along Gait Rite electronic walkway to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. 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. The gait symmetry index of spatio-temporal parameters will be calculated as (100%×(1-|1-Nonparetic/(Paretic side)|), which always results in a maximum value of 100%, irrespective of which limb demonstrates greater values, with improvements observed as positive values. Higher scores = better outcome.

  2. Change in Swing-time Symmetry

    Time frame: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)

    Participants will ambulate along Gait Rite electronic walkway to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. 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. The gait symmetry index of spatio-temporal parameters will be calculated as (100%×(1-|1-Nonparetic/(Paretic side)|), which always results in a maximum value of 100%, irrespective of which limb demonstrates greater values, with improvements observed as positive values. Higher scores = better outcome.

Secondary outcomes

  1. Change in 10 Meter Walk Test - Self-selected Velocity

    Time frame: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)

    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).

  2. Change in 10 Meter Walk Test - Fast Velocity

    Time frame: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)

    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).

  3. Change in 6 Minute Walk Test

    Time frame: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)

    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.

  4. Change in PCI During 6 Minute Walk Test

    Time frame: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)

    Participants completed the 6MWT as heart rate was recorded throughout the testing using a Polar H7 chest belt monitor. Prior to beginning the 6MWT, average resting heart rate was recorded for two minutes while the subject was seated and quiet. Cardiac efficiency during 6MWT was measured by physiological cost index (PCI), which reflects heart rate per meter walked. Reduced PCI indicates improved cardiac efficiency.

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

  • University of California, Los Angeles

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2018
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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