Clinical trial NCT04467437: Transcutaneous Stimulation for Neurological Populations
Official title: Transcutaneous Spinal Stimulation With Intensive Gait Training for Individuals With Neurologic Conditions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurological Disorder
Cerebral Palsy
Keywords: Spinal Electrical Stimulation
Treadmill Training
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
First posted: 2020-07-13
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change from baseline - Six Minute Walk Test
timeFrame: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
measure: Change from baseline - Ten Meter Walk Test
timeFrame: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
Secondary outcomes:
measure: Change from baseline - Kinetic and kinematic gait analysis using three dimensional camera system
timeFrame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
measure: Change from baseline - Electromyography recording of lower extremity muscles
timeFrame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
measure: Change from baseline - Gait Outcomes Assessment List
timeFrame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
measure: Change from baseline - Timed Up and Go
timeFrame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
measure: Change from baseline - Modified Ashworth and Tardieu Scales
timeFrame: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
measure: Change from baseline - Patient-Reported Outcomes Measurement Information System Pediatric Profile
timeFrame: Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Katherine M Steele, PhD
role: PRINCIPAL_INVESTIGATOR
References: