Transcutaneous Stimulation for Neurological Populations

Recruiting now · Not applicable

Conditions studied: Neurological Disorder, Cerebral Palsy

In brief

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).

Key facts

Study ID: NCT04467437
Run by: University of Washington
People needed: 20
Starts: 2021-01-01
Expected to finish: 2027-12-01
Last updated by the study team: 2024-09-19

Who can join

Age: 4 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

University of Washington — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.