Transcutaneous Stimulation for Neurological Populations

• ClinicalTrials.gov Identifier: NCT04467437
• Recruitment Status: Recruiting
• First Posted: July 13, 2020
• Last Update Posted: November 18, 2022
• Sponsor: University of Washington
• Collaborator: Seattle Children's Hospital
• Information provided by (Responsible Party): Chet Moritz, University of Washington

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Neurological Disorder; Cerebral Palsy	Other: Gait Training; Device: Transcutaneous Spinal Stimulation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Transcutaneous Spinal Stimulation With Intensive Gait Training for Individuals With Neurologic Conditions
• Actual Study Start Date: January 1, 2021
• Estimated Primary Completion Date: August 2024
• Estimated Study Completion Date: December 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Change from baseline - Kinetic and kinematic gait analysis using three dimensional camera system [ Time Frame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months. ]
   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.
2. Change from baseline - Electromyography recording of lower extremity muscles [ Time Frame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months. ]
   Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts.
3. Change from baseline - Gait Outcomes Assessment List [ Time Frame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months. ]
   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.
4. Change from baseline - Timed Up and Go [ Time Frame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months. ]
   Measurement of mobility and fall risk. The time to complete the test is recorded in seconds.
5. Change from baseline - Modified Ashworth and Tardieu Scales [ Time Frame: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months. ]
   Measurement of spasticity in muscles. The score range is between 0 and 5. The lower scores mean a better outcome.
6. Change from baseline - Patient-Reported Outcomes Measurement Information System Pediatric Profile [ Time Frame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months. ]

   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Siddhi R Shrivastav, BPTh, MS; 973-444-1940; siddhis@uw.edu

Contact: Chet T Moritz, PhD; 206-221-2842; ctmoritz@uw.edu

Locations

United States, Washington

University of Washington; Recruiting

Seattle, Washington, United States, 98115

Contact: Siddhi R Shrivastav siddhis@uw.edu

Contact: Chet T Moritz ctmoritz@uw.edu

Principal Investigator: Chet T Moritz, PhD

Principal Investigator: Katherine M Steele, PhD

Sponsors and Collaborators

University of Washington

Seattle Children's Hospital

Investigators

• Principal Investigator: Katherine M Steele, PhD; University of Washington

More Information

• Responsible Party: Chet Moritz, Associate Professor of Electrical & Computer Engineering and Rehabilitation Medicine, University of Washington
• ClinicalTrials.gov Identifier: NCT04467437
• Other Study ID Numbers: STUDY00008896
• First Posted: July 13, 2020
• Last Update Posted: November 18, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Chet Moritz, University of Washington:

Spinal Electrical Stimulation; Treadmill Training

Additional relevant MeSH terms:

Cerebral Palsy; Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases