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| Name | Class |
|---|---|
| The Craig H. Neilsen Foundation | OTHER |
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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Spinal Cord Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soshi Samejima, DPT, PhD | Contact | 2066160462 | soshis@uw.edu | |
| Katie Singsank, BA | Contact | singsank@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Soshi Samejima, DPT, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42008493 | Derived | 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. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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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.
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| Sham Stimulation | Device | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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:
| Repeated measures at every study visit, over a period of 6 months. |
| D014947 | Wounds and Injuries |