Transcutaneous Stimulation for Neurological Populations

Transcutaneous Spinal Stimulation With Intensive Gait Training for Individuals With Neurologic Conditions

The purpose of the study is to evaluate whether non-invasive stimulation over the spinal cord at the neck and/or lower back can improve walking function for people with neurologic conditions. Spinal stimulation has been used extensively for individuals with spinal cord injury, and has demonstrated improvements in function. This study will extend this work to other neurologic conditions, such as cerebral palsy and stroke, that also demonstrate similar impairments as spinal cord injury.

The primary aims of this study are to:

Aim 1: Evaluate impact of spinal stimulation on spasticity and locomotor function.

Aim 2: Investigate participant perceptions of spinal stimulation.

The investigators will be using a cross-over design study to compare intensive training only to intensive training combined with spinal stimulation. After an initial baseline period of up to 4 weeks (Phase I). Participants will have their first intervention phase of the study (Phase II). This will involve either intensive training only (Condition A) or intensive training combined with spinal stimulation (Condition B). This will be followed by a washout period with no intervention (Phase III) and then the second intervention phase (Phase IV). The second intervention phase will involve either Condition A or Condition B, whichever the participants did not received during Phase II. Phases II-IV will each last up to 8 weeks. After the intervention period is complete, the participant will be asked to come for follow-up visits up to 3 months after the intervention phases are completed (Phase V).

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Neurological Disorder
• Intervention / Treatment: Other: Gait Training; Device: Transcutaneous Spinal Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Siddhi R Shrivastav, BPTh, MS; Phone Number: 973-444-1940; Email: siddhis@uw.edu
• Study Contact Backup: Name: Chet T Moritz, PhD; Phone Number: 206-221-2842; Email: ctmoritz@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98115
      • Recruiting
      • University of Washington
      • Contact: Siddhi R Shrivastav; Email: siddhis@uw.edu
      • Contact: Chet T Moritz; Email: ctmoritz@uw.edu
      • Principal Investigator: Katherine M Steele, PhD
      • Principal Investigator: Chet T Moritz, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• have a neurologic condition
• can walk 20 yards, with or without an assistive device
• have stable medical condition
• are capable of performing simple cued motor tasks and who can follow 2-3 step commands
• have ability to attend up to 5 sessions per week physical therapy sessions and testing activities
• have adequate social support to be able to participate in training and assessment sessions, up to 5 sessions per week, for the duration of up to 11 months within the study period.
• who are volunteering to be involved in this study
• can read and speak English

Exclusion Criteria:

• have significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation.
• have cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
• have a history of uncontrolled seizures
• have unhealed fracture or other musculoskeletal impairment that might interfere with lower extremity rehabilitation or testing activities
• are dependent on ventilation support
• have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc) or drug delivery device (e.g. baclofen pump)
• have history of orthopedic surgery in lower extremities or neurosurgery that may be a confounding factor for interpretation of the results (such as tendon transfer, tendon or muscle lengthening for spasticity management, injection therapies to lower extremity muscles, etc.) in last 12 months
• have established osteoporosis and taking medication for osteoporosis treatment.
• have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
• have active cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intensive Training Only; Physical and gait training that targets rehabilitation of walking function.	Other: Gait Training; Training that targets rehabilitation of walking function
Active Comparator: Intensive Training Combined with Spinal Stimulation; Transcutaneous spinal stimulation combined with physical and gait training that targets rehabilitation of walking function.	Other: Gait Training; Training that targets rehabilitation of walking function; Device: Transcutaneous Spinal Stimulation; Non-invasive electrical stimulation of the spinal cord over the skin combined with gait training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline - Six Minute Walk Test	Measure of walking ability. The distance is reported in meters.	Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
Change from baseline - Ten Meter Walk Test	The measure of walking ability at fast and self-selected speeds. The walking speed is reported as meters per second.	Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline - Kinetic and kinematic gait analysis using three dimensional camera system	Measurement of leg function and walking ability. Joint angle is reported in angle degrees, and velocity is reported in meters per second. Kinematic analysis will able to used to measure gait coordination and spatiotemporal outcomes, such as step length and step time.	Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
Change from baseline - Electromyography recording of lower extremity muscles	Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts.	Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
Change from baseline - Gait Outcomes Assessment List	The patient-reported outcome measure for ambulatory children with cerebral palsy. The Gait Outcomes Assessment List comprises 48 items distributed across 7 subscales and spans all domains of the International Classification of Functioning, Disability, and Health. The score range is between 0 and 100. The higher scores mean a better outcome.	Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
Change from baseline - Timed Up and Go	Measurement of mobility and fall risk. The time to complete the test is recorded in seconds.	Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
Change from baseline - Modified Ashworth and Tardieu Scales	Measurement of spasticity in muscles. The score range is between 0 and 5. The lower scores mean a better outcome.	Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
Change from baseline - Patient-Reported Outcomes Measurement Information System Pediatric Profile	Includes six domains. These are depression, Anxiety, Physical Function-Mobility, Pain Interference, Fatigue, and Peer Relationships. Each domain contains 8 items, along with a single item on Pain Intensity scored between 0 to 10. The score range for each domain is between 1 and 5. The lower scores mean a better outcome.	Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Seattle Children's Hospital
• Investigators: Principal Investigator: Katherine M Steele, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Treadmill Training; Spinal Electrical Stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Nervous System Diseases
• Other Study ID Numbers: STUDY00008896

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No