Spinal Cord InjuriesNCT06540859
Spinal Cord Stimulation for Autonomic Recovery in Inpatient Rehabilitation After Acute SCI
A study testing Transcutaneous Spinal Cord Stimulation in people with Spinal Cord Injuries, run by University of Washington at 1 site in United States.
Trial summary
This study is a randomized, single-blind, two-arm sham-controlled clinical trial to evaluate the safety and efficacy of transcutaneous spinal cord stimulation (tSCS) over the lower thoracic and upper lumbar spinal cord segments for cardiovascular function in adults (21-65 years old) with cervical and upper thoracic… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Transcutaneous Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to Oct 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are between 21-65 years of age.
- SCI (non-progressive) at or above the T6 spinal segment.
- Admitted to inpatient rehabilitation units or discharged from inpatient rehabilitation units but within 4 months since the onset on injury.
- American Spinal Injury Association Impairment Scale (AIS) A-D for SCI.
- Have stable medical condition that would permit participation in testing activities.
- Willing and able to comply with all clinic visits and study-related procedures.
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- Able to understand and complete study-related questionnaires in English.
- Have no painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
- Are not currently pregnant or not intending to become pregnant during participation in this study.
- Are volunteering to be involved in this study.
- Must provide informed consent.
Who cannot join
- Have autoimmune etiology of spinal cord dysfunction/injury
- Have history of additional neurologic disease, such as stroke, MS, etc.
- Have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- Are ventilator dependent.
- Have clinically significant, unmanaged, depression, ongoing alcohol and/or drug abuse.
- Use any medication or treatment that in the opinion of the investigators indicates that it is not in the best interest of the participant to participate in this study.
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- Have Intrathecal baclofen pump.
- Have cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
- Have severe acute medical issue that in the investigators' judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to acute urinary tract infections, pressure sores, or unstable diabetes.
- Have pacemakers, stimulators, medication pumps in the trunk, deep brain stimulators, metallic devices in the head such as aneurysm clips/coils and stents, vagus nerve stimulators.
- Are a member of the investigational team or his/her immediate family.
- Have history of severe allergy (i.e. allergic reaction that could not be treated with antihistaminic medication)
- Have malabsorption syndrome, primary hyperthyroidism, and/or hypogonadism.
- Have a history of seizures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katie Singsank, BA contact
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Soshi Samejima, DPT, PhD
About this study
This study is a randomized, single-blind, two-arm sham-controlled clinical trial to evaluate the safety and efficacy of transcutaneous spinal cord stimulation (tSCS) over the lower thoracic and upper lumbar spinal cord segments for cardiovascular function in adults (21-65 years old) with cervical and upper thoracic spinal cord injury (SCI) (≥T6) AIS A-D during inpatient rehabilitation and outpatient visits within three months after the onset. We will recruit 26 individuals with SCI, admitted to inpatient rehabilitation facilities (IRFs) or after discharged from IRFs. We will also examine the effect of tSCS on lower urinary tract (LUT) and bowel functions as secondary outcomes.
The main questions this study aims to answer are:
Read more
- Assess the safety of single and repeated tSCS session(s) on cardiovascular function in the acute SCI: We will test the safety of single tSCS at T10-L2 session at rest and during orthostatic challenge (i.e., situ-up tests) at the baseline and the effect of five tSCS sessions on cardiovascular function in individuals with SCI ≥ T6.
- Assess the effect of long-term tSCS on autonomic function in the subacute SCI phase: We will investigate the efficacy of long-term (total 18 sessions) tSCS on cardiovascular and pelvic organ functions.
- Evaluate the sustained effect of tSCS on autonomic recovery six months after the onset of SCI: We will assess the sustained effect of repeated tSCS sessions (18 sessions) on cardiovascular and pelvic organ functions at 6-month post-SCI.
Participants will:
- Receive either transcutaneous spinal cord stimulation or "sham" spinal cord stimulation while inpatient in the first 8 weeks (Part A).
- Those willing and able to come after discharge or after the 8 weeks will be asked to come back and complete additional tSCS for a total of 18 weeks (Part B), with a follow-up period of 6 months. All participants will receive tSCS during this outpatient follow-up portion of the study.
- During assessment visits the researchers will perform a variety of exams including a neurologic, cardiovascular, pulmonary, bladder and bowel, physical, and autonomic exam, and will ask questions about quality of life and functioning. Participants will be asked to complete a test of how well their bowels are functioning (colonic transit test) and an abdominal X-Ray.
Researchers will compare those who receive tSCS to those who receive sham stimulation to see if tSCS is an effective treatment for improving the body's autonomic functioning following recent-onset SCI.
- Conditions
- Spinal Cord Injuries
- Being tested
- Transcutaneous Spinal Cord Stimulation, Sham Stimulation
- Keywords
- Transcutaneous Spinal Cord Stimulation, Inpatient Rehabilitation, Cardiovascular Recovery following SCI, Bladder and Bowel Recovery following SCI
- 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 Cord StimulationDevice
Also called tSCS
Non-invasive electrical stimulation of the spinal cord over the skin. A portable tSCS device, SCONE or TESCoN (SpineX Inc., USA), whichever available, will be used to deliver 1ms pulses with 10kHz carrier frequency at 30 Hz, which has demonstrated autonomic recovery in our previous studies. The location of tSCS is predetermined (at T10 and T11 vertebral levels). The stimulation intensity will range from 10 to 200 mA and specific criteria will be followed to determine the optimal therapeutic stimulation.
Sham StimulationDevice
Non-invasive electrical stimulation of a lower extremity muscle group over the skin. A portable tSCS device, SCONE or TESCoN (SpineX Inc., USA), whichever available, will be used to deliver sham stimulation. The intensity of electrical stimulation will be briefly ramped up to a level at which the participants report perceiving the stimulation (i.e., sensory threshold), then ramped down and turned off for the remainder of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Spinal Cord Stimulation | Experimental | Device: Transcutaneous Spinal Stimulation
Non-invasive electrical stimulation of the spinal cord over the skin. A portable tSCS device, SCONE or TESCoN (SpineX Inc., USA), whichever available, will be used to deliver 1ms pulses with 10kHz carrier frequency at 30 Hz, which has demonstrated autonomic recovery in our previous studies. The location of tSCS is predetermined (at T10 and T11 vertebral levels). The stimulation intensity will range from 10 to 200 mA Receives: Device: Transcutaneous Spinal Cord Stimulation |
| Sham stimulation | Sham comparator | Device: Sham Stimulation
Non-invasive electrical stimulation of a lower extremity muscle group over the skin. The intensity of electrical stimulation will be briefly ramped up to a level at which the participants report perceiving the stimulation (i.e., sensory threshold), then ramped down and turned off for the remainder of the intervention. Receives: Device: Transcutaneous Spinal Cord Stimulation; Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic Blood Pressure (BP)
Continuous beat-by-beat BP will be measured using a finger photoplethysmography. This will be done throughout the study, including during orthostatic challenge using sit-up test.
Measured: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
Heart Rate (HR) monitoring during tSCS
Electrocardiography (ECG) at resting and during sit-up test
Measured: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
frequency and severity of uncontrolled BP episodes such as OH and autonomic dysreflexia (AD) in 24 hours.
24-hour BP monitoring obtained throughout the study using Finapres NOVA
Measured: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
Secondary outcomes (11)
International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)
Scores for questions on the ISAFSCI range from 0 to 2, with 0 representing complete loss of control and 2 representing normal functioning. Lower scores equal worse health functioning.
Measured: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
International Standards for Neurological Classification of Spinal Cord Injury
level and severity of damage to motor and sensory pathways will be determined by trained clinicians. Pin prick and light touch will be done by researchers on participant's left and right side. Check marks are given for each prick or touch that is felt by the participant, then tallied. Scores range from 0-56 for both the Left and Right side of the body, and 0-112 for the total score. High scores represent greater sensory functioning.
Measured: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
Autonomic dysfunction following Spinal Cord Injury (ADFSCI) measure
The Autonomic Dysfunction following SCI (ADFSCI) measure will be used to assess severity and frequency of autonomic dysreflexia. Greater scores equal greater frequency of autonomic dysfunction, ranging from 0 (never) to 4 (very often) for each item.
Measured: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
Numeric Pain Rating Scale
The Numeric Pain Rating Scale is a self-report measure, asking patients to circle a number on a scale ranging from 0 (no pain) to 10 (worst pain possible). Higher scores represent greater pain.
Measured: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
International SCI Pain Basic Dataset
Standardized questionnaire for the collection and reporting of pain in the SCI population. Scores range from 0 to 10, with higher scores indicating greater pain interference and worse functioning.
Measured: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
Neurogenic Bladder Symptom Score
The Neurogenic Bladder Symptom Score is a data collection form for measuring symptom burden of lower urinary tract functioning among those living with SCI. The Neurogenic Bladder Symptom Score (NBSS) is a validated 24 item questionnaire that measures bladder symptoms across 3 different domains: incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23); there is a single general urinary QOL question scored from 0 (pleased) to 4 (unhappy) [6]. For all domains, a higher score represents a worse symptom burden or QOL.
Measured: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
International SCI Lower Urinary Tract Function Basic Data Set (ISNCSCI)
The International SCI Lower Urinary Tract Function Dataset is a data collection form for the collection and reporting of lower urinary tract function in the SCI population. Participants are asked to mark either main or supplementary for type of bladder emptying, and then answer yes or no questions regarding type of appliances used to collect urinary incontinence, drugs with possible influence on urinary tract within the past 4 weeks, and any surgical procedures on the urinary tract. This data collection form does not use numbers and instead collects qualitative data only; there is no score range.
Measured: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
International SCI Bowel Function Basic Data Set (ISCIBFDS)
Standardized data collection form for the collection and reporting of bowel function in the SCI population. The International SCI Bowel Function Dataset is a data collection instrument that asks participants qualitative questions which are assigned a score. Select items are then totaled to compute the Neurogenic Bowel Dysfunction (NBD) score. Scores range from 0 to 14 or more, with higher scores indicating greater neurogenic bowel dysfunction.
Measured: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
Colonic Transit Time
GI and colonic transit time will be assessed using radiopaque marker intake and an abdominal X-ray. Participants will take radiopaque markers for 6 days. On the 6th day, an abdominal X-ray will be taken. The movement of the radiopaque markers through the GI system will indicate colonic transit time, with slower transit time indicating possible neurogenic bowel.
Measured: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
Changes in Lower Urinary Tract and Bowel Function
Maximum cystometric capacity measured via urodynamics. If appointments are available, participants will complete a urodynamic assessment in accordance with Good Urodynamic Practices recommended by the International Continence Society and international SCI Urodynamic data. Urodynamic assessments valuate how well the lower urinary tract, which includes the bladder, urethra, and sphincters, works to store and release urine. UDSs can help diagnose issues with the lower urinary tract and can show why there might be blockages or leaks. Abnormalities on the urodynamic assessment results may indicate neurogenic bladder.
Measured: Post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at 2 timepoints over 6 months.
Frequency and Severity of Adverse Events
Serious Adverse Events and Adverse Events will be documented by study staff. For the purpose of this study, an adverse event (AE) is any untoward medical occurrence in a subject during participation in the clinical study or with use of the experimental agent being studied. An adverse finding can include a sign, symptom, abnormal assessment (vital signs, skin changes, neurological changes), or any combination of these.
A serious adverse event (SAE) is any adverse event that results in one or more of the following outcomes:
- Death
- A life-threatening event
- Inpatient hospitalization or prolongation of existing hospitalization
- A persistent or significant disability/incapacity
- A congenital anomaly or birth defect
- An important medical event based upon appropriate medical judgment
Measured: Repeated measures at every study visit, over a period of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Dec 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Parallel groups
- Model description
- randomized, single-blind, two-arm sham-controlled clinical trial with two arms (tSCS compared to sham-stimulation) and two parts (Part A and Part B). Part A will be conducted while participants are staying in inpatient rehabilitation. Participants will be randomized to either tSCS or sham stimulation. Part B will take place in outpatient rehabilitation medicine and all participants will receive tSCS stimulation for up to 18 sessions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Soshi Samejima, University of Washington
- Investigators
- Soshi Samejima, DPT, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540859
- Sponsor's protocol ID
- STUDY00020243
- Status last verified
- Mar 2025
- First submitted
- 27 Jun 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nakahara R, Nasson S, Bieler E, Putsche-Young E, Aguila B, Shen J, Chung E, Winston L, Burns S, Crane D, Eugenio M, Krogh K, Krassioukov A, Moritz C, Samejima S. Effects of non-invasive spinal cord stimulation on autonomic function in individuals with subacute spinal cord injury: A pilot clinical trial protocol. PLoS One. 2026 Apr 20;21(4):e0347211. doi: 10.1371/journal.pone.0347211. eCollection 2026.
PubMed 42008493
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation for Autonomic Recovery in Inpatient Rehabilitation After Acute SCI
- ClinicalTrials.gov ID
- NCT06540859
- Acronym / sponsor ID
- STUDY00020243
- Conditions
- Spinal Cord Injuries
- Keywords
- Transcutaneous Spinal Cord Stimulation, Inpatient Rehabilitation, Cardiovascular Recovery following SCI, Bladder and Bowel Recovery following SCI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 6 Aug 2024 (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.
This study is a randomized, single-blind, two-arm sham-controlled clinical trial to evaluate the safety and efficacy of transcutaneous spinal cord stimulation (tSCS) over the lower thoracic and upper lumbar spinal cord segments for cardiovascular function in adults (21-65 years old) with cervical and upper thoracic spinal cord injury (SCI) (≥T6) AIS A-D during inpatient rehabilitation and outpatient visits within three months after the onset. We will recruit 26 individuals with SCI, admitted to inpatient rehabilitation facilities (IRFs) or after discharged from IRFs. We will also examine the effect of tSCS on lower urinary tract (LUT) and bowel functions as secondary outcomes.
The main questions this study aims to answer are:
- Assess the safety of single and repeated tSCS session(s) on cardiovascular function in the acute SCI: We will test the safety of single tSCS at T10-L2 session at rest and during orthostatic challenge (i.e., situ-up tests) at the baseline and the effect of five tSCS sessions on cardiovascular function in individuals with SCI ≥ T6.
- Assess the effect of long-term tSCS on autonomic function in the subacute SCI phase: We will investigate the efficacy of long-term (total 18 sessions) tSCS on cardiovascular and pelvic organ functions.
- Evaluate the sustained effect of tSCS on autonomic recovery six months after the onset of SCI: We will assess the sustained effect of repeated tSCS sessions (18 sessions) on cardiovascular and pelvic organ functions at 6-month post-SCI.
Participants will:
- Receive either transcutaneous spinal cord stimulation or "sham" spinal cord stimulation while inpatient in the first 8 weeks (Part A).
- Those willing and able to come after discharge or after the 8 weeks will be asked to come back and complete additional tSCS for a total of 18 weeks (Part B), with a follow-up period of 6 months. All participants will receive tSCS during this outpatient follow-up portion of the study.
- During assessment visits the researchers will perform a variety of exams including a neurologic, cardiovascular, pulmonary, bladder and bowel, physical, and autonomic exam, and will ask questions about quality of life and functioning. Participants will be asked to complete a test of how well their bowels are functioning (colonic transit test) and an abdominal X-Ray.
Researchers will compare those who receive tSCS to those who receive sham stimulation to see if tSCS is an effective treatment for improving the body's autonomic functioning following recent-onset SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, single-blind, two-arm sham-controlled clinical trial with two arms (tSCS compared to sham-stimulation) and two parts (Part A and Part B). Part A will be conducted while participants are staying in inpatient rehabilitation. Participants will be randomized to either tSCS or sham stimulation. Part B will take place in outpatient rehabilitation medicine and all participants will receive tSCS stimulation for up to 18 sessions.
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Spinal Cord Stimulation | Experimental | Device: Transcutaneous Spinal Cord StimulationDevice: Transcutaneous Spinal Stimulation Non-invasive electrical stimulation of the spinal cord over the skin. A portable tSCS device, SCONE or TESCoN (SpineX Inc., USA), whichever available, will be used to deliver 1ms pulses with 10kHz carrier frequency at 30 Hz, which has demonstrated autonomic recovery in our previous studies. The location of tSCS is predetermined (at T10 and T11 vertebral levels). The stimulation intensity will range from 10 to 200 mA |
| Sham stimulation | Sham comparator | Device: Transcutaneous Spinal Cord Stimulation, Device: Sham StimulationDevice: Sham Stimulation Non-invasive electrical stimulation of a lower extremity muscle group over the skin. The intensity of electrical stimulation will be briefly ramped up to a level at which the participants report perceiving the stimulation (i.e., sensory threshold), then ramped down and turned off for the remainder of the intervention. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Are between 21-65 years of age.
- SCI (non-progressive) at or above the T6 spinal segment.
- Admitted to inpatient rehabilitation units or discharged from inpatient rehabilitation units but within 4 months since the onset on injury.
- American Spinal Injury Association Impairment Scale (AIS) A-D for SCI.
- Have stable medical condition that would permit participation in testing activities.
Key exclusion criteria (14 listed)
- Have autoimmune etiology of spinal cord dysfunction/injury
- Have history of additional neurologic disease, such as stroke, MS, etc.
- Have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- Are ventilator dependent.
- Have clinically significant, unmanaged, depression, ongoing alcohol and/or drug abuse.
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 Cord StimulationAlso: tSCSNon-invasive electrical stimulation of the spinal cord over the skin. A portable tSCS device, SCONE or TESCoN (SpineX Inc., USA), whichever available, will be used to deliver 1ms pulses with 10kHz carrier frequency at 30 Hz, which has demonstrated autonomic recovery in our previous studies. The location of tSCS is predetermined (at T10 and T11 vertebral levels). The stimulation intensity will range from 10 to 200 mA and specific criteria will be followed to determine the optimal therapeutic stimulation. | Device | Sham stimulation, Transcutaneous Spinal Cord Stimulation |
| Sham StimulationNon-invasive electrical stimulation of a lower extremity muscle group over the skin. A portable tSCS device, SCONE or TESCoN (SpineX Inc., USA), whichever available, will be used to deliver sham stimulation. The intensity of electrical stimulation will be briefly ramped up to a level at which the participants report perceiving the stimulation (i.e., sensory threshold), then ramped down and turned off for the remainder of the intervention. | Device | Sham stimulation |
Primary outcome
Change in systolic Blood Pressure (BP)
Time frame: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
Continuous beat-by-beat BP will be measured using a finger photoplethysmography. This will be done throughout the study, including during orthostatic challenge using sit-up test.
Heart Rate (HR) monitoring during tSCS
Time frame: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
Electrocardiography (ECG) at resting and during sit-up test
frequency and severity of uncontrolled BP episodes such as OH and autonomic dysreflexia (AD) in 24 hours.
Time frame: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
24-hour BP monitoring obtained throughout the study using Finapres NOVA
11 secondary outcomes
International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)
Time frame: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
International Standards for Neurological Classification of Spinal Cord Injury
Time frame: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
Autonomic dysfunction following Spinal Cord Injury (ADFSCI) measure
Time frame: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
Numeric Pain Rating Scale
Time frame: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
International SCI Pain Basic Dataset
Time frame: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
Neurogenic Bladder Symptom Score
Time frame: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
International SCI Lower Urinary Tract Function Basic Data Set (ISNCSCI)
Time frame: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
International SCI Bowel Function Basic Data Set (ISCIBFDS)
Time frame: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
Colonic Transit Time
Time frame: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
Changes in Lower Urinary Tract and Bowel Function
Time frame: Post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at 2 timepoints over 6 months.
Frequency and Severity of Adverse Events
Time frame: Repeated measures at every study visit, over a period of 6 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 27 Mar 2025.
- Derived from this study: PubMed 42008493Nakahara R, Nasson S, Bieler E, Putsche-Young E, Aguila B, Shen J, Chung E, Winston L, Burns S, Crane D, Eugenio M, Krogh K, Krassioukov A, Moritz C, Samejima S. Effects of non-invasive spinal cord stimulation on autonomic function in individuals with subacute spinal cord injury: A pilot clinical trial protocol. PLoS One. 2026 Apr 20;21(4):e0347211. doi: 10.1371/journal.pone.0347211. eCollection 2026.
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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.
Katie Singsank, BA contact
Soshi Samejima, DPT, 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 Cord Stimulation 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 11 inclusion and 14 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 27 Mar 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. Some participants in this study may receive a placebo. 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, PhD (2066160462, soshis@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic Blood Pressure (BP) (time frame: Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.). The study lists 3 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 NCT06540859, which also lists 1 linked publication.
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 27 Mar 2025.