Recruiting

Transcutaneous Stimulation

Sponsor:

University of Washington

Code:

NCT04467437

Conditions

Neurological Disorder

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 4 - 70

Healthy Volunteers: Not accepted

Interventions

Gait Training

Transcutaneous Spinal Stimulation

Study Details

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

Study ID

NCT04467437

Start date

Jan 1, 2021

Status verified date

Sep, 2024

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intensive Training Only

Physical and gait 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.

Interventions

Gait Training

Training that targets rehabilitation of walking function

Transcutaneous Spinal Stimulation

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

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Siddhi R Shrivastav, BPTh, MS

973-444-1940siddhis@uw.edu

Chet T Moritz, PhD

206-221-2842ctmoritz@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98115

Contacts

Siddhi R Shrivastav

siddhis@uw.edu

Chet T Moritz

ctmoritz@uw.edu

Principal Investigator:

Chet T Moritz, PhD

More Information

Sponsor

University of Washington

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Keywords

  • Spinal Electrical Stimulation
  • Treadmill Training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2024-09-19.