Transcutaneous Stimulation for Neurological Populations

NCT04467437 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00008896
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Neurological Disorder; Cerebral Palsy

Keywords

Spinal Electrical Stimulation; Treadmill Training

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change from baseline - Kinetic and kinematic gait analysis using three dimensional camera system

  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

  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

  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

  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

  Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.

Study Arms (2)

Intensive Training Only

ACTIVE COMPARATOR

Physical and gait training that targets rehabilitation of walking function.

Other: Gait Training

Intensive Training Combined with Spinal Stimulation

ACTIVE COMPARATOR

Transcutaneous spinal stimulation combined with physical and gait training that targets rehabilitation of walking function.

Other: Gait Training; Device: Transcutaneous Spinal Stimulation

Interventions

Gait Training OTHER

Training that targets rehabilitation of walking function

Intensive Training Combined with Spinal Stimulation; Intensive Training Only

Transcutaneous Spinal Stimulation DEVICE

Non-invasive electrical stimulation of the spinal cord over the skin combined with gait training

Intensive Training Combined with Spinal Stimulation

Eligibility Criteria

• Age: 4 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Seattle Children's Hospital: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98115, United States

RECRUITING

MeSH Terms

Conditions

Nervous System Diseases; Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Katherine M Steele, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siddhi R Shrivastav, BPTh, MS

CONTACT

973-444-1940; siddhis@uw.edu

Chet T Moritz, PhD

CONTACT

206-221-2842; ctmoritz@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Electrical & Computer Engineering and Rehabilitation Medicine

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 13, 2020
• Study Start: January 1, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)