Noninvasive Spinal Stimulation in Stroke

NCT03714282 | Completed Results FDA Device

• 1 other identifier: STU00206430
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 with hemiplegia due to stroke.

Conditions

Stroke

Keywords

Spinal cord stimulation; electrical stimulation; locomotion

Outcome Measures

Primary Outcomes (2)

• Change in Step-length Symmetry Using Symmetry Index

  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.

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

• Change in Swing-time Symmetry

  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.

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

Secondary Outcomes (4)

• Change in 10 Meter Walk Test - Self-selected Velocity

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

• Change in 10 Meter Walk Test - Fast Velocity

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

• Change in 6 Minute Walk Test

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

• Change in PCI During 6 Minute Walk Test

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

Study Arms (2)

Noninvasive Spinal Stimulation with Gait Training

EXPERIMENTAL

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.

Device: Noninvasive spinal stimulation with gait training

Conventional Gait Training

ACTIVE COMPARATOR

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.

Device: Conventional gait training

Interventions

Noninvasive spinal stimulation with gait training DEVICE

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

Noninvasive Spinal Stimulation with Gait Training

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.

Conventional Gait Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Able and willing to give written consent and comply with study procedures

You may not qualify if:

• 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)
• 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
• 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)

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Moon Y, Yang C, Veit NC, McKenzie KA, Kim J, Aalla S, Yingling L, Buchler K, Hunt J, Jenz S, Shin SY, Kishta A, Edgerton VR, Gerasimenko YP, Roth EJ, Lieber RL, Jayaraman A. Noninvasive spinal stimulation improves walking in chronic stroke survivors: a proof-of-concept case series. Biomed Eng Online. 2024 Apr 1;23(1):38. doi: 10.1186/s12938-024-01231-1.

  PMID: 38561821 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Limitations include a small sample size, between subject variability in tSCS stimulation, stim group participants were not matched to their controls based on gait symmetry (primary outcome measure)

Results Point of Contact

• Title: Arun Jayaraman, PT, PhD; Director of Max Nader Lab for Rehabilitation Technologies and Outcomes
• Organization: Shirley Ryan AbilityLab

ajayaraman@sralab.org

3122386875

Study Officials

• Arun Jayaraman, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Max Näder Center

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 22, 2018
• Study Start: October 18, 2018
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: March 17, 2026
• Results First Posted: March 17, 2026

Record last verified: 2026-03

Locations

US (1)