Transcutaneous Stimulation for Neurological Populations

Official title

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

Overview

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).

Interventions

• 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

Primary outcome measures

• 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.]
• 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.]

Secondary outcome measures (6)

• 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.]
• 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.]
• 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.]
• 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.]
• 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.]
• 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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Washington — Seattle

Identifiers

NCT: NCT04467437 · STUDY00008896

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗