Spinal Cord InjuriesNCT03509558
Transcutaneous Spinal Stimulation and Exercise for Locomotion
A study testing Transcutaneous spinal stimulation and Physical Therapy in people with Spinal Cord Injuries, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Transcutaneous spinal stimulation and Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2018to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 29Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Soshi Samejima, soshis@uw.edu
Chet Moritz, ctmoritz@uw.edu
About this study
Official title: 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.
Read more
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
- Being tested
- Transcutaneous spinal stimulation, Physical Therapy
- Keywords
- Spinal electrical stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous spinal stimulationDevice
Also called Physical Therapy
Non-invasive electrical stimulation of spinal cord over the skin combined with physical therapy to improve walking and standing functions
Physical TherapyOther
physical therapy to improve walking and standing functions
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous spinal stimulation & Physical therapy | Active comparator | Transcutaneous electrical stimulation combined with physical therapy that targets rehabilitation of walking and standing functions Receives: Device: Transcutaneous spinal stimulation; Other: Physical Therapy |
| Physical therapy only | Active comparator | Physical therapy that targets rehabilitation of walking and standing functions Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walk Test
Measurement of walking ability. The distance is reported in meter.
Measured: 1-11 months
Two-minute walk test
A measurement of endurance that assesses walking distance over two minutes.
Measured: 1-11 months
Secondary outcomes (15)
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
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.
Measured: 1-11 months
Somatosensory evoked potentials
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.
Measured: 1-11 months
Somatosensory evoked potentials
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.
Measured: 1-11 months
Motor evoked potentials
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.
Measured: 1-11 months
Motor evoked potentials
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.
Measured: 1-11 months
Berg Balance Test
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).
Measured: 1-11 months
Ten-meter walk test
Measurement of walking ability. The walking speed is reported in meter per second.
Measured: 1-11 months
Gait analysis
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.
Measured: 1-11 months
Kinetic and kinematic gait analysis using 3D camera system
Measurement of leg function and walking ability. Velocity is reported in meter per second.
Measured: 1-11 months
Electromyography recording of lower extremity and trunk muscles
Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts.
Measured: 1-11 months
Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire
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.
Measured: 1-11 months
Spinal Cord Injury - Functional Index (SCI-FI) questionnaire
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.
Measured: 1-11 months
Modified Ashworth Scale
Measurement of spasticity. Tests resistance to passive movement about joints. Score range from 0-4, with 6 choices.
Measured: 1-11 months
Neurogenic Bowel Dysfunction Score
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).
Measured: 1-11 months
Neurogenic Bladder Symptom Score
objective and validated self-report questionnaire to assess bladder symptoms in patients with neurogenic bladder dysfunction.
Measured: 1-11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start28 Feb 2018
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chet Moritz, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509558
- Sponsor's protocol ID
- STUDY00003070
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2018
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Stimulation With Intensive Physical Therapy for Locomotion
- ClinicalTrials.gov ID
- NCT03509558
- Acronym / sponsor ID
- STUDY00003070
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal electrical stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous spinal stimulation & Physical therapy | Active comparator | Device: Transcutaneous spinal stimulation, Other: Physical TherapyTranscutaneous electrical stimulation combined with physical therapy that targets rehabilitation of walking and standing functions |
| Physical therapy only | Active comparator | Other: Physical TherapyPhysical therapy that targets rehabilitation of walking and standing functions |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous spinal stimulationAlso: Physical TherapyNon-invasive electrical stimulation of spinal cord over the skin combined with physical therapy to improve walking and standing functions | Device | Transcutaneous spinal stimulation & Physical therapy |
| Physical Therapyphysical therapy to improve walking and standing functions | Other | Physical therapy only, Transcutaneous spinal stimulation & Physical therapy |
Primary outcome
Six-Minute Walk Test
Time frame: 1-11 months
Measurement of walking ability. The distance is reported in meter.
Two-minute walk test
Time frame: 1-11 months
A measurement of endurance that assesses walking distance over two minutes.
15 secondary outcomes
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
Time frame: 1-11 months
Somatosensory evoked potentials
Time frame: 1-11 months
Somatosensory evoked potentials
Time frame: 1-11 months
Motor evoked potentials
Time frame: 1-11 months
Motor evoked potentials
Time frame: 1-11 months
Berg Balance Test
Time frame: 1-11 months
Ten-meter walk test
Time frame: 1-11 months
Gait analysis
Time frame: 1-11 months
Kinetic and kinematic gait analysis using 3D camera system
Time frame: 1-11 months
Electromyography recording of lower extremity and trunk muscles
Time frame: 1-11 months
Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire
Time frame: 1-11 months
Spinal Cord Injury - Functional Index (SCI-FI) questionnaire
Time frame: 1-11 months
Modified Ashworth Scale
Time frame: 1-11 months
Neurogenic Bowel Dysfunction Score
Time frame: 1-11 months
Neurogenic Bladder Symptom Score
Time frame: 1-11 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous spinal stimulation and Physical Therapy in people with Spinal Cord Injuries, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soshi Samejima, DPT, MS (206 221-8961, soshis@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-Minute Walk Test (time frame: 1-11 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.