Recruiting

Transcutaneous Spinal Stimulation & ExerciseTranscutaneous Spinal Stimulation and Exercise for Locomotion

Sponsor:

University of Washington

Code:

NCT03509558

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

Transcutaneous spinal stimulation

Physical Therapy

Study Details

Brief summary:

Growing evidence indicates that electrical spinal cord stimulation improves motor functions both immediately and over the long term via modulating the excitability of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated, and painless lumbosacral transcutaneous electrical stimulation strategy was demonstrated to be effective in improving lower limb motor function in participants with spinal cord injury. Our current project, cervical transcutaneous electrical stimulation and intensive exercise for arms and hands are also revealing a significant improvement in upper extremity function. Additionally, the subject and caregiver noted that stair climbing ability has been substantially enhanced starting from the first week of cervical stimulation treatment and continues to date.

This study is a prospective efficacy trial of combined transcutaneous cervical and lumbosacral electrical stimulation with physical therapy for improving locomotion in people with anatomically incomplete tetraplegia and paraplegia.

This experiment design consists of testing walking function with and without transcutaneous spinal cord stimulation. A two to four-phase intervention program will include physical therapy and spinal cord stimulation with physical therapy. The length of any intervention phase, and number of measurements performed during that phase, will be determined by multiple factors, including participants' health condition, availability, and response to intervention. Between each intervention, washout periods of up to one month may be used to determine any after-effects of the interventions.

The intervention arms will be repeated if the functional improvement does not reach a plateau during the first two months of intervention. Physical therapy will include functional training (e.g., walking training) and strength training. Each spinal cord stimulation with physical therapy intervention block can use transcutaneous lumbosacral stimulation or cervical and lumbosacral stimulation. Both immediate and lasting improvements in lower extremity function and autonomic function via transcutaneous spinal cord stimulation and intensive physical therapy may be evaluated.

Conditions

Spinal Cord Injuries

Study ID

NCT03509558

Start date

Feb 28, 2018

Status verified date

Mar, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

Has spinal cord injury (T12 or higher level) of at least 1-year duration
Is between 21 and 70 years of age
Has difficulty with leg functions and mobility in activities of daily living (e.g. walking, transferring surface to surface, standing)
Has stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in lower extremity rehabilitation or testing activities
Is capable of performing simple cued motor tasks
Has ability to attend up to 5 sessions per week physical therapy sessions and testing activities
Has 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
Is volunteering to be involved in this study
Cleared for gait training by the primary physician of the subject
Has the ability to read and speak English

Exclusion Criteria:

Has autoimmune etiology of spinal cord dysfunction/injury
Has history of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc.
Has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
Has rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
Has 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.
Has active cancer
Has cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
Has unhealed fracture, contracture, pressure sore, urinary tract infection, or other illnesses that might interfere with lower extremity rehabilitation or testing activities
Has any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician
is pregnant
is dependent on ventilation support
Has implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc)
Has depression or anxiety based on the Center for Epidemiologic Studies Depression Scale (CESD) (score >16/60) and General Anxiety Disorder-7 item Questionnaire (score >9/21), respectively
Has alcohol and/or drug abuse
Has cognitive impairment based on Short Portable Mental Status Questionnaire (SPMSQ) (score >2/10)
is unable to read and/or comprehend the consent form
is unable to understand the instructions given as part of the study
Has established osteoporosis and taking medication for osteoporosis treatment
Has bone mineral density T scores ≤ -3.5 or Z scores ≤ -2.5 in the anteroposterior lumbar spine and/or proximal femur measured by a DEXA scan for subjects weight bearing and ambulating outside of a body-weight supporting exoskeleton (if participants are clear for other criteria and have not been examined by Dual Energy Xray Absorptiometry (DEXA) at the screening, we will ask participants to undergo DEXA to reveal any risk of weight bearing activity)
Has low-energy fracture history before or after spinal cord injury
History of orthopedic surgery in lower extremities that may be a confounding factor for interpretation of the results (such as tendon transfer, tendon or muscle lengthening for spasticity management, arthrodesis, etc.)
fixed lower extremity joint contractures
is taller than 80 inches and/or more than 350 pounds body weights, due to the limitation of the experimental equipment such as the body weight support system
lacks the ability to fully comprehend and/or perform study procedures in the investigator's opinion/judgement
has history of severe allergy (i.e. allergic reaction that could not be treated with antihistaminic medication)
has malabrosption syndrome, primary hyperthyroidism, and/or hypogonadism
has a history of seizures
has chronic headaches or migraines
has deep brain stimulators, metallic devices in the head such as aneurysm clips/coils and stents, vagus nerve stimulators

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Transcutaneous spinal stimulation & Physical therapy

Transcutaneous electrical stimulation combined with physical therapy that targets rehabilitation of walking and standing functions

active comparator: Physical therapy only

Physical therapy that targets rehabilitation of walking and standing functions

Interventions

Transcutaneous spinal stimulation

Non-invasive electrical stimulation of spinal cord over the skin combined with physical therapy to improve walking and standing functions

Physical Therapy

physical therapy to improve walking and standing functions

Primary outcome measure

Six-Minute Walk Test [ Time Frame: 1-11 months ]
Two-minute walk test [ Time Frame: 1-11 months ]

Central Contacts and Locations

Central contacts

Soshi Samejima, DPT, MS

206 221-8961 soshis@uw.edu

Chet Moritz, PhD

206 221-2842 ctmoritz@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Soshi Samejima

soshis@uw.edu

Chet Moritz

ctmoritz@uw.edu

Principal Investigator:

Chet Moritz, PhD

More Information

Sponsor

University of Washington

Last update posted

Aug 5, 2025

Last verified

Mar, 2025

Keywords

Spinal electrical stimulation

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 2025-08-05.