Transcutaneous Spinal Stimulation and Exercise for Locomotion

July 31, 2025 updated by: Chet Moritz, University of Washington

Transcutaneous Spinal Stimulation With Intensive Physical Therapy for Locomotion

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Soshi Samejima, DPT, MS
  • Phone Number: 206 221-8961
  • Email: soshis@uw.edu

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chet Moritz, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Transcutaneous spinal stimulation & Physical therapy
Transcutaneous electrical stimulation combined with physical therapy that targets rehabilitation of walking and standing functions
Device: Transcutaneous spinal stimulation
Non-invasive electrical stimulation of spinal cord over the skin combined with physical therapy to improve walking and standing functions
Other Names:
  • Physical Therapy
Other: Physical Therapy
physical therapy to improve walking and standing functions
Active Comparator: Physical therapy only
Physical therapy that targets rehabilitation of walking and standing functions
Other: Physical Therapy
physical therapy to improve walking and standing functions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Six-Minute Walk Test
Time Frame: 1-11 months
Measurement of walking ability. The distance is reported in meter.
1-11 months
Two-minute walk test
Time Frame: 1-11 months
A measurement of endurance that assesses walking distance over two minutes.
1-11 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
Time Frame: 1-11 months
Standard neurologic examination that is routinely used to determine the levels and severity of spinal cord injury. Includes manual muscle strength testing and dermatomal light touch and pin prick sensory examination.
1-11 months
Somatosensory evoked potentials
Time Frame: 1-11 months
Measurement of latency of electrical potentials that is recorded by surface electrodes over the scalp following electrical stimulation of peripheral nerve from the wrist. The latency of the response is reported in micro-seconds.
1-11 months
Somatosensory evoked potentials
Time Frame: 1-11 months
Measurement of amplitude of electrical potentials that is recorded by surface electrodes over the scalp following electrical stimulation of peripheral nerve from the wrist. The amplitude of the response is reported in micro-volts.
1-11 months
Motor evoked potentials
Time Frame: 1-11 months
Measurement of latency of electrical potentials that is recorded by surface electrodes over the skin of limb muscles following spinal stimulation or magnetic stimulation of brain over the scalp. The latency of the response is reported in micro-seconds.
1-11 months
Motor evoked potentials
Time Frame: 1-11 months
Measurement of amplitude of electrical potentials that is recorded by surface electrodes over the skin of limb muscles following spinal stimulation or magnetic stimulation of brain over the scalp. The amplitude of the response is reported in micro-volts.
1-11 months
Berg Balance Test
Time Frame: 1-11 months
Measurement of balance in standing and sitting. The balance score consists of 14 items and is reported in the scale of 56 (each items are score in 0-4).
1-11 months
Ten-meter walk test
Time Frame: 1-11 months
Measurement of walking ability. The walking speed is reported in meter per second.
1-11 months
Gait analysis
Time Frame: 1-11 months
Measurement of leg function and walking ability. Joint angle is reported in degree angle. Step length is reported in centimeters and swing time is reported in seconds.
1-11 months
Kinetic and kinematic gait analysis using 3D camera system
Time Frame: 1-11 months
Measurement of leg function and walking ability. Velocity is reported in meter per second.
1-11 months
Electromyography recording of lower extremity and trunk muscles
Time Frame: 1-11 months
Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts.
1-11 months
Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire
Time Frame: 1-11 months
Patient reported quality of life scale. The SCI-QOL consists of 19 item banks, and is reported by T-score comparing the mean of the functional level in the population.
1-11 months
Spinal Cord Injury - Functional Index (SCI-FI) questionnaire
Time Frame: 1-11 months
Patient reported functional scale. The SCI-QOL consists of 10 item banks, and is reported by T-score comparing the mean of the functional level in the population.
1-11 months
Modified Ashworth Scale
Time Frame: 1-11 months
Measurement of spasticity. Tests resistance to passive movement about joints. Score range from 0-4, with 6 choices.
1-11 months
Neurogenic Bowel Dysfunction Score
Time Frame: 1-11 months

self-report questionnaire designed to help healthcare professionals evaluate the effectiveness of their patient's current bowel management routine by assessing the impact it has on the patient's quality of life.

Questions ask about background parameters (n=8), faecal incontinence (n=10), constipation (n=10), obstructed defecation (n=8), and impact on quality of life (QOL).
1-11 months
Neurogenic Bladder Symptom Score
Time Frame: 1-11 months
objective and validated self-report questionnaire to assess bladder symptoms in patients with neurogenic bladder dysfunction.
1-11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00003070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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