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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05167786
• Other study ID #: STU00215009
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: August 25, 2027

Study information

• Verified date: November 2023
• Source: Shirley Ryan AbilityLab
• Contact: Kelly McKenzie, DPT
• Phone: 312-238-7111
• Email: kmckenzie[@]sralab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: August 25, 2027
• Est. primary completion date: August 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• Noninvasive spinal stimulation
Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation to subjects.
• 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:
• Sham
Subject will not receive either transcutaneous electrical spinal cord stimulation or perform lower limb locomotor activities.
• 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.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gait Symmetry	Participants will ambulate along Gait Rite electronic walkway 3 times per gait speed to evaluate 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.	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	Change in 6 Minute Walk Test	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.	Aim 2: Baseline pre-intervention, 4 weeks into the intervention, immediately post intervention and 3 months post intervention for intervention 1 and 2.
Secondary	Change in 10 Meter Walk Test	This test will examine the patient's gait speed. Patients will be directed to walk 3 times per gait speed to evaluate gait pattern at both their self-selected and safe fast gait 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).	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.