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Transcutaneous Stimulation for Neurological Populations

Primary Purpose

Neurological Disorder, Cerebral Palsy

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gait Training

Transcutaneous Spinal Stimulation

About this trial

This is an interventional treatment trial for Neurological Disorder focused on measuring Spinal Electrical Stimulation, Treadmill Training

Eligibility Criteria

10 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Intensive Training Only

Intensive Training Combined with Spinal Stimulation

Arm Description

Physical and gait training that targets rehabilitation of walking function.

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

Outcomes

Primary Outcome Measures

Change from baseline - Six Minute Walk Test

Measure of walking ability. The distance is reported in meters.

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.

Secondary Outcome Measures

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.

Change from baseline - Electromyography recording of lower extremity muscles

Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts.

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.

Change from baseline - Timed Up and Go

Measurement of mobility and fall risk. The time to complete the test is recorded in seconds.

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.

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.

Full Information

NCT ID

NCT04467437

First Posted

July 7, 2020

Last Updated

November 14, 2022

Sponsor

University of Washington

Collaborators

Seattle Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04467437

Brief Title

Transcutaneous Stimulation for Neurological Populations

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

Seattle Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurological Disorder, Cerebral Palsy

Keywords

Spinal Electrical Stimulation, Treadmill Training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intensive Training Only

Arm Type

Active Comparator

Arm Description

Physical and gait training that targets rehabilitation of walking function.

Arm Title

Intensive Training Combined with Spinal Stimulation

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Gait Training

Intervention Description

Training that targets rehabilitation of walking function

Intervention Type

Device

Intervention Name(s)

Transcutaneous Spinal Stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline - Six Minute Walk Test

Description

Measure of walking ability. The distance is reported in meters.

Time Frame

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

Title

Change from baseline - Ten Meter Walk Test

Description

The measure of walking ability at fast and self-selected speeds. The walking speed is reported as meters per second.

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Change from baseline - Electromyography recording of lower extremity muscles

Description

Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts.

Time Frame

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

Title

Change from baseline - Gait Outcomes Assessment List

Description

Time Frame

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

Title

Change from baseline - Timed Up and Go

Description

Measurement of mobility and fall risk. The time to complete the test is recorded in seconds.

Time Frame

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

Title

Change from baseline - Modified Ashworth and Tardieu Scales

Description

Measurement of spasticity in muscles. The score range is between 0 and 5. The lower scores mean a better outcome.

Time Frame

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

Title

Change from baseline - Patient-Reported Outcomes Measurement Information System Pediatric Profile

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Siddhi R Shrivastav, BPTh, MS

Phone

973-444-1940

siddhis@uw.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Chet T Moritz, PhD

Phone

206-221-2842

ctmoritz@uw.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katherine M Steele, PhD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Siddhi R Shrivastav

siddhis@uw.edu

First Name & Middle Initial & Last Name & Degree

Chet T Moritz

ctmoritz@uw.edu

First Name & Middle Initial & Last Name & Degree

Chet T Moritz, PhD

First Name & Middle Initial & Last Name & Degree

Katherine M Steele, PhD

12. IPD Sharing Statement

Plan to Share IPD

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Transcutaneous Stimulation for Neurological Populations

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