Spinal Cord InjuriesNCT05267951
Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function After Spinal Cord Injury
A study testing Open-loop Stimulation, Close-loop Stimulation and Functional Task Practice in people with Spinal Cord Injuries, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of non-invasive (transcutaneous) closed-loop electrical spinal cord stimulation for recovery of upper limb function (Aim 1) and spasticity (Aim 2) following 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?
- Open-loop Stimulation, Close-loop Stimulation and Functional Task Practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2022to 30 Jun 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 cervical (C8 or higher), incomplete (American Spinal Cord Injury Impairment Scale - C or D) traumatic spinal cord injury, minimum 1-year post-injury
- has difficulty with hand functions in activities of daily living (e.g., dressing, grooming, feeding)
- stable medical condition without cardiopulmonary disease or autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities
- capable of performing simple cued motor tasks
- has ability to attend intervention/functional task training and assessment sessions 3 times/week
- has adequate social support to participate in all intervention and baseline/follow-up assessment sessions throughout 40 weeks.
- has ability to read and speak English
Who cannot join
- dependent on ventilation support
- has implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump
- has metallic devices and implants in the head (e.g., deep brain stimulators, aneurysm clips/coils, and stents, vagus nerve stimulators)
- has a history or current signs/symptoms of syringomyelia (progressive pain, muscle weakness, and/or sensory loss; deterioration of bowel/bladder function)
- has autoimmune etiology of spinal cord dysfunction/injury
- has received botulinum toxin injections in upper extremity muscles in the prior 6 months
Show all 22Show fewer
- has tendon transfer or nerve transfer surgery in the upper extremity,
- taking tizanidine, dantrolene or diazepam
- has history of seizures or increased risk for seizures
- has history of chronic headaches or migraines
- has history of neurologic diseases, 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 cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
- unhealed fracture, contracture, pressure sore, or frequent urinary tract infections or other illnesses that might interfere with upper extremity rehabilitation or testing activities
- has a history of severe allergy (i.e., allergic reaction that could not be treated with antihistaminic medication
- has alcohol and/or drug abuse (subject's verbal statement)
- has cancer
- pregnant (Childbearing potential will be asked at screening, baseline, and every subsequent visit in which the subject would receive transcutaneous spinal cord stimulation and/or Transcranial Magnetic Stimulation whether the participant could be pregnant. Pregnancy will be ruled out by an over-the-counter urine pregnancy test for all females of childbearing potential (1) at the time of enrollment, (2) prior to all sessions that include Transcranial Magnetic Stimulation, and also prior to the intervention phases of (3) closed-loop or (4) open-loop stimulation. Additional pregnancy tests may be performed if there is a concern of pregnancy.)
- lack of ability to fully comprehend, cooperate and/or safely perform study procedures in the investigator's opinion/judgment
- unable to read and/or comprehend the consent form
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
Fatma Inanici, MD, Ph.D., 206-787-2692, finanici@uw.edu
Chet T. Moritz, PhD
About this study
The purpose of this study is to assess the efficacy of non-invasive (transcutaneous) closed-loop electrical spinal cord stimulation for recovery of upper limb function (Aim 1) and spasticity (Aim 2) following spinal cord injury.
Read the detailed description
After being informed about the purpose, study timeline, and procedures, all participants giving written informed consent will undergo repeated baseline measurements throughout four weeks, followed by intensive exercise therapy for six weeks.
Next, participants will receive (1) closed-loop stimulation and (2) open-loop stimulation treatment for Aim 1 Section of the study. Stimulation will be delivered non-invasively using skin electrodes on the back of the neck. Each treatment arm will last six weeks. The investigators will determine the order of the treatment arms randomly. For closed-loop stimulation, The investigators will place a sensor on the arm muscles over the skin. This sensor will detect the movement and start the stimulation accordingly.
For Aim 2 Section, intervention arms will consist of (1) transcutaneous stimulation, followed by (2) spasticity-reducing stimulation treatment arms.
There will be a 6-week waiting period between two stimulation arms where participants will not receive any stimulation or exercise therapy. Treatments will last 90 minutes per session, three sessions per week. Overall participation in the study will last ten months: Four weeks baseline + three treatment periods (each will last six weeks) + six weeks waiting period between stimulation treatments + 12 weeks follow-up.
- Conditions
- Spinal Cord Injuries
- Being tested
- Open-loop Stimulation, Close-loop Stimulation, Functional Task Practice
- 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.
Open-loop StimulationDevice
Spinal cord stimulation will be applied continuously over the skin throughout the intervention session.
Close-loop StimulationDevice
Spinal cord stimulation will start and stop based on the signals that come from the sensors placed on upper limb muscle surfaces.
Functional Task PracticeOther
Also called Intensive exercise therapy
Exercise therapy consists of repeated functional hand and arm movements
| Study group | Role | What they receive |
|---|---|---|
| Open-loop Stimulation | Experimental | Continuous stimulation Receives: Device: Open-loop Stimulation; Other: Functional Task Practice |
| Close-loop Stimulation | Experimental | Intended movement-based stimulation. Receives: Device: Close-loop Stimulation; Other: Functional Task Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2
Measurement of upper limb strength, sensation, qualitative prehension, and quantitative prehension (range 0-188, higher score mean better outcome)
Measured: "Repeated measurements once every two weeks throughout the study, an average of 10 months".
Change from baseline- Capabilities of Upper Extremity Test
Measures unilateral and bilateral hand and arm function (range 0-128, higher score mean better outcome)
Measured: "Repeated measurements once every two weeks throughout the study, an average of 10 months".
Change from baseline- Grip and Pinch Force
Grip and pinch force measurement using a dynamometer (higher score mean better outcome)
Measured: "Repeated measurements once every two weeks throughout the study, an average of 10 months".
Change from baseline- Modified Ashworth Scale
Clinician administered assessment of spasticity (range 0-4, lower score mean better outcome)
Measured: "Repeated measurements once every two weeks throughout the study, an average of 10 months".
Secondary outcomes (7)
Change from baseline- International Standards for Neurologic Classification of Spinal Cord Injury - Motor Score
Standard manual muscle strength examination (Range 0-100 points, higher score mean better outcome)
Measured: "Repeated measurements once every eight weeks throughout the study, an average of 10 months".
Change from baseline- International Standards for Neurologic Classification of Spinal Cord Injury - Sensory Score
Standard examination of dermatomal sensation (range 0-224 points, higher score mean better outcome)
Measured: "Repeated measurements once every eight weeks throughout the study, an average of 10 months".
Change from baseline- International Standards of Autonomic Functions after Spinal Cord Injury
Clinician assessment to document remaining autonomic functions after spinal cord injury
Measured: "Repeated measurements once every eight weeks throughout the study, an average of 10 months".
Change from baseline- H-Reflex
Electrophysiologic measurement of H-reflex (lower Hmax/Mmax ratio mean better outcome)
Measured: "Repeated measurements once every eight weeks throughout the study, an average of 10 months".
Change from baseline- Somatosensory Evoked Potentials
Electrophysiologic evaluation of sensory pathways between the brain and the limb (shorter latency mean better outcome)
Measured: "Repeated measurements once every eight weeks throughout the study, an average of 10 months".
Change from baseline- Motor Evoked Potentials
Electrophysiologic evaluation of motor pathways between the brain and the muscles (higher amplitude mean better outcome)
Measured: "Repeated measurements once every eight weeks throughout the study, an average of 10 months".
Change from baseline Spinal Cord Independence Measure Self Report
Quantification of the level of independence in daily activities (range 0-100 points, higher score mean better outcome)
Measured: "Repeated measurements once every eight weeks throughout the study, an average of 10 months".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start12 Oct 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Model description
- Participants who participate in Aim 1 Section of the study will receive open-loop and closed-loop stimulation intervention arms in a randomized order. The order of the two interventions in the Aim 2 Section of the study will be the same for all participants enrolled in the Aim 2 Section of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Chet Moritz, University of Washington
- Investigators
- Chet Moritz, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267951
- Sponsor's protocol ID
- STUDY00013469
- Other IDs
- CDMRP-SC200287
- Status last verified
- Aug 2026
- First submitted
- 15 Oct 2021
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.
PubMed 29877852Inanici F, Brighton LN, Samejima S, Hofstetter CP, Moritz CT. Transcutaneous Spinal Cord Stimulation Restores Hand and Arm Function After Spinal Cord Injury. IEEE Trans Neural Syst Rehabil Eng. 2021;29:310-319. doi: 10.1109/TNSRE.2021.3049133. Epub 2021 Mar 2.
PubMed 33400652McPherson JG, Miller RR, Perlmutter SI. Targeted, activity-dependent spinal stimulation produces long-lasting motor recovery in chronic cervical spinal cord injury. Proc Natl Acad Sci U S A. 2015 Sep 29;112(39):12193-8. doi: 10.1073/pnas.1505383112. Epub 2015 Sep 14.
PubMed 26371306
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05267951
- Acronym / sponsor ID
- STUDY00013469
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 7 Mar 2022 (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.
The purpose of this study is to assess the efficacy of non-invasive (transcutaneous) closed-loop electrical spinal cord stimulation for recovery of upper limb function (Aim 1) and spasticity (Aim 2) following spinal cord injury.
Detailed description
After being informed about the purpose, study timeline, and procedures, all participants giving written informed consent will undergo repeated baseline measurements throughout four weeks, followed by intensive exercise therapy for six weeks.
Next, participants will receive (1) closed-loop stimulation and (2) open-loop stimulation treatment for Aim 1 Section of the study. Stimulation will be delivered non-invasively using skin electrodes on the back of the neck. Each treatment arm will last six weeks. The investigators will determine the order of the treatment arms randomly. For closed-loop stimulation, The investigators will place a sensor on the arm muscles over the skin. This sensor will detect the movement and start the stimulation accordingly.
For Aim 2 Section, intervention arms will consist of (1) transcutaneous stimulation, followed by (2) spasticity-reducing stimulation treatment arms.
There will be a 6-week waiting period between two stimulation arms where participants will not receive any stimulation or exercise therapy. Treatments will last 90 minutes per session, three sessions per week. Overall participation in the study will last ten months: Four weeks baseline + three treatment periods (each will last six weeks) + six weeks waiting period between stimulation treatments + 12 weeks follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants who participate in Aim 1 Section of the study will receive open-loop and closed-loop stimulation intervention arms in a randomized order. The order of the two interventions in the Aim 2 Section of the study will be the same for all participants enrolled in the Aim 2 Section of the study.
| Arm | Type | Receives |
|---|---|---|
| Open-loop Stimulation | Experimental | Device: Open-loop Stimulation, Other: Functional Task PracticeContinuous stimulation |
| Close-loop Stimulation | Experimental | Device: Close-loop Stimulation, Other: Functional Task PracticeIntended movement-based stimulation. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- has cervical (C8 or higher), incomplete (American Spinal Cord Injury Impairment Scale - C or D) traumatic spinal cord injury, minimum 1-year post-injury
- has difficulty with hand functions in activities of daily living (e.g., dressing, grooming, feeding)
- stable medical condition without cardiopulmonary disease or autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities
- capable of performing simple cued motor tasks
- has ability to attend intervention/functional task training and assessment sessions 3 times/week
Key exclusion criteria (22 listed)
- dependent on ventilation support
- has implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump
- has metallic devices and implants in the head (e.g., deep brain stimulators, aneurysm clips/coils, and stents, vagus nerve stimulators)
- has a history or current signs/symptoms of syringomyelia (progressive pain, muscle weakness, and/or sensory loss; deterioration of bowel/bladder function)
- has autoimmune etiology of spinal cord dysfunction/injury
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 |
|---|---|---|
| Open-loop StimulationSpinal cord stimulation will be applied continuously over the skin throughout the intervention session. | Device | Open-loop Stimulation |
| Close-loop StimulationSpinal cord stimulation will start and stop based on the signals that come from the sensors placed on upper limb muscle surfaces. | Device | Close-loop Stimulation |
| Functional Task PracticeAlso: Intensive exercise therapyExercise therapy consists of repeated functional hand and arm movements | Other | Close-loop Stimulation, Open-loop Stimulation |
Primary outcome
Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2
Time frame: "Repeated measurements once every two weeks throughout the study, an average of 10 months".
Measurement of upper limb strength, sensation, qualitative prehension, and quantitative prehension (range 0-188, higher score mean better outcome)
Change from baseline- Capabilities of Upper Extremity Test
Time frame: "Repeated measurements once every two weeks throughout the study, an average of 10 months".
Measures unilateral and bilateral hand and arm function (range 0-128, higher score mean better outcome)
Change from baseline- Grip and Pinch Force
Time frame: "Repeated measurements once every two weeks throughout the study, an average of 10 months".
Grip and pinch force measurement using a dynamometer (higher score mean better outcome)
Change from baseline- Modified Ashworth Scale
Time frame: "Repeated measurements once every two weeks throughout the study, an average of 10 months".
Clinician administered assessment of spasticity (range 0-4, lower score mean better outcome)
7 secondary outcomes
Change from baseline- International Standards for Neurologic Classification of Spinal Cord Injury - Motor Score
Time frame: "Repeated measurements once every eight weeks throughout the study, an average of 10 months".
Change from baseline- International Standards for Neurologic Classification of Spinal Cord Injury - Sensory Score
Time frame: "Repeated measurements once every eight weeks throughout the study, an average of 10 months".
Change from baseline- International Standards of Autonomic Functions after Spinal Cord Injury
Time frame: "Repeated measurements once every eight weeks throughout the study, an average of 10 months".
Change from baseline- H-Reflex
Time frame: "Repeated measurements once every eight weeks throughout the study, an average of 10 months".
Change from baseline- Somatosensory Evoked Potentials
Time frame: "Repeated measurements once every eight weeks throughout the study, an average of 10 months".
Change from baseline- Motor Evoked Potentials
Time frame: "Repeated measurements once every eight weeks throughout the study, an average of 10 months".
Change from baseline Spinal Cord Independence Measure Self Report
Time frame: "Repeated measurements once every eight weeks throughout the study, an average of 10 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 18 Aug 2026.
- Background: PubMed 29877852Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.
- Background: PubMed 33400652Inanici F, Brighton LN, Samejima S, Hofstetter CP, Moritz CT. Transcutaneous Spinal Cord Stimulation Restores Hand and Arm Function After Spinal Cord Injury. IEEE Trans Neural Syst Rehabil Eng. 2021;29:310-319. doi: 10.1109/TNSRE.2021.3049133. Epub 2021 Mar 2.
- Background: PubMed 26371306McPherson JG, Miller RR, Perlmutter SI. Targeted, activity-dependent spinal stimulation produces long-lasting motor recovery in chronic cervical spinal cord injury. Proc Natl Acad Sci U S A. 2015 Sep 29;112(39):12193-8. doi: 10.1073/pnas.1505383112. Epub 2015 Sep 14.
- 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.
Chet Moritz, Ph.D. 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 Open-loop Stimulation, Close-loop Stimulation and Functional Task Practice 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 7 inclusion and 22 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 18 Aug 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 Fatma Inanici, MD., Ph.D. (206 787 2692, finanici@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2 (time frame: "Repeated measurements once every two weeks throughout the study, an average of 10 months".). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05267951, which also lists 3 linked publications.
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 18 Aug 2026.