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

Overview

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.

Interventions

• 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.
• 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.
• Other Exploratory Phase - Optimization of Gait Training and Spinal Stimulation
  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 measures

• Change in Gait Symmetry [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 measures (2)

• Change in 6 Minute Walk Test [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.]
• Change in 10 Meter Walk Test [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.]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Shirley Ryan AbilityLab — Chicago

Identifiers

NCT: NCT05167786 · STU00215009

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗