Spinal Cord Injury CervicalADDRESSNCT03184792
Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury
A study testing Transcutaneous spinal stimulation and Physical therapy in people with Spinal Cord Injury Cervical and Upper Extremity Dysfunction, run by University of Washington at 1 site in United States.
Trial summary
Stimulation of the spinal cord may induce the growth and reorganization of neural pathways leading to the re-animation of paralyzed limbs. Growing evidence indicates that electrical spinal cord stimulation improves motor functions immediately via modulating the excitability of spinal circuitry in patients with spinal… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Spinal Cord Injury Cervical, Upper Extremity Dysfunction
- 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
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Cervical (C7 or higher) spinal cord injury at least 1-year duration
- Incomplete spinal cord injury (American Spinal Injury Association Impairment Scale (AIS) C or D)
- Between 21 and 70 years of age
- Difficulty with hand functions in activities of daily living (e.g. dressing, grooming, feeding)
- Stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities
- Capable of performing simple cued motor tasks
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- Ability to attend 2 to 5 sessions of weekly physical therapy sessions and testing activities
- Adequate social support to be able to participate in weekly training and assessment sessions for the duration of 6 months within the study period.
- Ability to read and speak English
Who cannot join
- Autoimmune etiology of spinal cord dysfunction/injury
- History of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc.
- Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
- Rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- 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.
- Active cancer
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- Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
- Unhealed fracture, contracture, pressure sore, or urinary tract infection or other illnesses that might interfere with upper extremity rehabilitation or testing activities
- Any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician
- Pregnancy
- Tendon or nerve transfer surgery in the upper limbs
- Botulinum toxin injections in the prior 6 months
- Dependent on ventilation support
- Implanted stimulator (e.g. vagus nerve stimulator, pacemaker, cochlear implant, etc).
- Has depression or anxiety based on Patient Health Questionnaire and General Anxiety Disorder-7 item Questionnaire
- Diagnosed with syringomyelia
- Alcohol and/or drug abuse.
- Cognitive impairment based on Short Portable Mental Status Questionnaire
- Unable to read and/or comprehend the consent form.
- Unable to understand the instructions given as part of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington
Seattle, Washington, 981095
About this study
Official title: Activity Dependent Rehabilitation Via Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury
Stimulation of the spinal cord may induce the growth and reorganization of neural pathways leading to the re-animation of paralyzed limbs. Growing evidence indicates that electrical spinal cord stimulation improves motor functions immediately via modulating the excitability of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated and painless transcutaneous electrical stimulation strategy was demonstrated to be effective for improving lower limb motor function in healthy individuals and in patients with spinal cord injury. The investigators hypothesize that transcutaneous cervical electrical stimulation can enhance conscious motor control and functions of hand and arm via neuromodulation of spinal network.
This study is a prospective efficacy trial of transcutaneous cervical electrical stimulation for improving upper limb function in patients with traumatic or degenerative cervical spinal cord injury. Transcutaneous electrical spinal stimulation device is not regulated by the United States Food and Drug Administration for treatment of spinal cord injury.
The interventions include either transcutaneous cervical spinal electrical stimulation combined with physical therapy or physical therapy only. The order of the interventions will be randomized for each subject in a delayed cross-over design. Total duration of the study is 6 months, including 4 weeks baseline measurements, 8 weeks intervention and 12 weeks follow-up. Both immediate and lasting improvements in hand motor and sensory function via transcutaneous cervical spinal stimulation will be evaluated.
- Being tested
- Transcutaneous spinal stimulation, Physical therapy
- Keywords
- Spinal electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous spinal stimulationDevice
Non-invasive electrical stimulation of cervical spinal cord over the skin
Physical therapyOther
Also called Exercise therapy
Physical therapy to improve arm and hand functions
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy only (Arm A) | Active comparator | Physical therapy that targets the rehabilitation of upper extremity functions Receives: Other: Physical therapy |
| Transcutaneous cervical electrical stimulation combined with physical therapy (Arm B) | Experimental | Application of Transcutaneous cervical electrical stimulation combined with physical therapy that targets the rehabilitation of upper extremity functions Receives: Device: Transcutaneous spinal stimulation; Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graded and Redefined Assessment of Strength, Sensibility and Prehension Test (GRASSP Test)
GRASSP is a clinical impairment measurement tool that quantifies hand impairment caused by cervical spinal cord injury. The tool measures three domains of function: strength (manual muscle strength testing), sensibility (Semmes-Weinstein monofilament sensation test), and prehension (ability and performance to generate various grasp and pinch movements using a water bottle, jar, key, pegs, coins, and nuts).
The total score is calculated as the sum of the subscale scores. The minimum score is zero, and the maximum score is 232 points. Higher Scores mean a better outcome.
Score change before and after each intervention is calculated.
Measured: 6 months
Secondary outcomes (6)
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination Subscale 1: Myotomal-based Motor Examination - measures the motor function of the extremities. The minimum score is zero, and the maximum score is 100. Higher scores represent better outcomes.
Subscale 2: The Dermatomal-based Sensory Examination - measures the sensory function of the whole body dermatomes. The minimum score is zero, and the maximum score is 224. Higher scores represent better outcomes.
Measured: 6 months
Grip and Pinch Strength
Hand strength measurement by dynamometry.
The change in strength (improvement) before and at the end of each intervention arm is calculated.
Measured: 6 months
Numeric Pain Rating Scale
Patient reported pain rating on a 0 to 10 scale. The mean score change (improvement) before and at the end of each intervention arm is calculated.
Zero means no pain, 10 means the worst pain one can imagine. Higher scores mean worse pain.
Measured: 6 months
Penn Spasm Score
Patient-reported spasm rating. Scores are mild (0), moderate (1), and severe (2).
Measured: 6 months
Spinal Cord Independence Measure (SCIM)
Clinician-administered disability questionnaire for patients with spinal cord lesions.
The total SCIM scores range from 0 to 100. Higher scores mean better outcomes. Score change (improvement) relative to baseline or previous intervention arm is calculated.
Measured: 6 months
World Health Organization-Quality of Life - (WHO-QoL-BREF)
Patient-reported quality of life scale. A higher score indicates a higher quality of life. Score change (improvement) relative to baseline or prior intervention arm is calculated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Dec 2017
- Primary completion30 Aug 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord Injury CervicalStudies 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
- Model description
- Participants will be randomized into two groups: Group 1.) Six weeks of "Physical therapy only" (Arm A) as the first intervention and then 6 weeks of "Transcutaneous spinal stimulation \& Physical therapy" (Arm B) as the second intervention. Group 2.) Six weeks of "Transcutaneous spinal stimulation \& Physical therapy" (Arm B) as the first intervention, and then "Physical therapy only" (Arm A) as the second intervention.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chet Moritz, University of Washington
- Investigators
- Chet T Moritz, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184792
- Sponsor's protocol ID
- STUDY00002985
- Acronym
- ADDRESS
- Status last verified
- Sep 2025
- First submitted
- 7 Jun 2017
- Last updated
- 4 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity Dependent Rehabilitation Via Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03184792
- Acronym / sponsor ID
- ADDRESS / STUDY00002985
- Keywords
- Spinal electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Posted 4 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stimulation of the spinal cord may induce the growth and reorganization of neural pathways leading to the re-animation of paralyzed limbs. Growing evidence indicates that electrical spinal cord stimulation improves motor functions immediately via modulating the excitability of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated and painless transcutaneous electrical stimulation strategy was demonstrated to be effective for improving lower limb motor function in healthy individuals and in patients with spinal cord injury. The investigators hypothesize that transcutaneous cervical electrical stimulation can enhance conscious motor control and functions of hand and arm via neuromodulation of spinal network.
This study is a prospective efficacy trial of transcutaneous cervical electrical stimulation for improving upper limb function in patients with traumatic or degenerative cervical spinal cord injury. Transcutaneous electrical spinal stimulation device is not regulated by the United States Food and Drug Administration for treatment of spinal cord injury.
The interventions include either transcutaneous cervical spinal electrical stimulation combined with physical therapy or physical therapy only. The order of the interventions will be randomized for each subject in a delayed cross-over design. Total duration of the study is 6 months, including 4 weeks baseline measurements, 8 weeks intervention and 12 weeks follow-up. Both immediate and lasting improvements in hand motor and sensory function via transcutaneous cervical spinal stimulation will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into two groups: Group 1.) Six weeks of "Physical therapy only" (Arm A) as the first intervention and then 6 weeks of "Transcutaneous spinal stimulation \& Physical therapy" (Arm B) as the second intervention. Group 2.) Six weeks of "Transcutaneous spinal stimulation \& Physical therapy" (Arm B) as the first intervention, and then "Physical therapy only" (Arm A) as the second intervention.
| Arm | Type | Receives |
|---|---|---|
| Physical therapy only (Arm A) | Active comparator | Other: Physical therapyPhysical therapy that targets the rehabilitation of upper extremity functions |
| Transcutaneous cervical electrical stimulation combined with physical therapy (Arm B) | Experimental | Device: Transcutaneous spinal stimulation, Other: Physical therapyApplication of Transcutaneous cervical electrical stimulation combined with physical therapy that targets the rehabilitation of upper extremity functions |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Cervical (C7 or higher) spinal cord injury at least 1-year duration
- Incomplete spinal cord injury (American Spinal Injury Association Impairment Scale (AIS) C or D)
- Between 21 and 70 years of age
- Difficulty with hand functions in activities of daily living (e.g. dressing, grooming, feeding)
- Stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities
Key exclusion criteria (20 listed)
- Autoimmune etiology of spinal cord dysfunction/injury
- History of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc.
- Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
- Rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- 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 stimulationNon-invasive electrical stimulation of cervical spinal cord over the skin | Device | Transcutaneous cervical electrical stimulation combined with physical therapy (Arm B) |
| Physical therapyAlso: Exercise therapyPhysical therapy to improve arm and hand functions | Other | Physical therapy only (Arm A), Transcutaneous cervical electrical stimulation combined with physical therapy (Arm B) |
Primary outcome
Graded and Redefined Assessment of Strength, Sensibility and Prehension Test (GRASSP Test)
Time frame: 6 months
GRASSP is a clinical impairment measurement tool that quantifies hand impairment caused by cervical spinal cord injury. The tool measures three domains of function: strength (manual muscle strength testing), sensibility (Semmes-Weinstein monofilament sensation test), and prehension (ability and performance to generate various grasp and pinch movements using a water bottle, jar, key, pegs, coins, and nuts). The total score is calculated as the sum of the subscale scores. The minimum score is zero, and the maximum score is 232 points. Higher Scores mean a better outcome. Score change before and after each intervention is calculated.
6 secondary outcomes
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
Time frame: 6 months
Grip and Pinch Strength
Time frame: 6 months
Numeric Pain Rating Scale
Time frame: 6 months
Penn Spasm Score
Time frame: 6 months
Spinal Cord Independence Measure (SCIM)
Time frame: 6 months
World Health Organization-Quality of Life - (WHO-QoL-BREF)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Chet T Moritz, PhD principal investigator
University of Washington
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 Injury Cervical and Upper Extremity Dysfunction, 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 9 inclusion and 20 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: finished, as of the sponsor's last update on 4 Nov 2025. 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?
Yes. Results are posted in the registry (first posted 4 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graded and Redefined Assessment of Strength, Sensibility and Prehension Test (GRASSP Test) (time frame: 6 months). 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 4 Nov 2025.