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

Shirley Ryan AbilityLab

Status: Enrolling

Conditions: Stroke

Treatments: Device: Noninvasive spinal stimulation with gait training; Other: Exploratory Phase - Optimization of Gait Training and Spinal Stimulation; Device: Conventional gait training

Study type: Interventional

Funder types: Other

Identifiers

NCT05167786

STU00215009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 4 patient groups

Aim 1: Gait Training + Stimulation

Experimental group

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.

Treatment:

Other: Exploratory Phase - Optimization of Gait Training and Spinal Stimulation

Device: Noninvasive spinal stimulation with gait training

Aim 1: Gait Training + Sham Stimulation

Active Comparator group

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.

Treatment:

Device: Conventional gait training

Aim 2: Gait Training + Stimulation

Experimental group

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.

Treatment:

Other: Exploratory Phase - Optimization of Gait Training and Spinal Stimulation

Device: Noninvasive spinal stimulation with gait training

Aim 2: Gait Training + Sham Stimulation

Active Comparator group

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.

Treatment:

Device: Conventional gait training