Recruiting

Spinal Cord Stimulation

Sponsor:

University of Washington

Code:

NCT06540859

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Spinal Cord Stimulation

Sham Stimulation

Study Details

Brief 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 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:

1. 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.
2. 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.
3. 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

Study ID

NCT06540859

Start date

Dec 1, 2024

Status verified date

Mar, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Are between 21-65 years of age.
2. SCI (non-progressive) at or above the T6 spinal segment.
3. Admitted to inpatient rehabilitation units or discharged from inpatient rehabilitation units but within 4 months since the onset on injury.
4. American Spinal Injury Association Impairment Scale (AIS) A-D for SCI.
5. Have stable medical condition that would permit participation in testing activities.
6. Willing and able to comply with all clinic visits and study-related procedures.
7. Able to understand and complete study-related questionnaires in English.
8. Have no painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
9. Are not currently pregnant or not intending to become pregnant during participation in this study.
10. Are volunteering to be involved in this study.
11. Must provide informed consent.

Exclusion Criteria:

1. Have autoimmune etiology of spinal cord dysfunction/injury
2. Have history of additional neurologic disease, such as stroke, MS, etc.
3. Have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
4. Are ventilator dependent.
5. Have clinically significant, unmanaged, depression, ongoing alcohol and/or drug abuse.
6. 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.
7. Have Intrathecal baclofen pump.
8. Have cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
9. 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.
10. 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.
11. Are a member of the investigational team or his/her immediate family.
12. Have history of severe allergy (i.e. allergic reaction that could not be treated with antihistaminic medication)
13. Have malabsorption syndrome, primary hyperthyroidism, and/or hypogonadism.
14. Have a history of seizures.

Study Design

Enrollment

26 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transcutaneous Spinal Cord Stimulation

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

sham comparator: Sham stimulation

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.

Interventions

Transcutaneous Spinal Cord 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 and specific criteria will be followed to determine the optimal therapeutic stimulation.

Sham Stimulation

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.

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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Soshi Samejima, DPT, PhD

2066160462soshis@uw.edu

Katie Singsank, BA

singsank@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

More Information

Sponsor

University of Washington

Last update posted

Mar 27, 2025

Last verified

Mar, 2025

Keywords

  • Transcutaneous Spinal Cord Stimulation
  • Inpatient Rehabilitation
  • Cardiovascular Recovery following SCI
  • Bladder and Bowel Recovery following SCI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of Washington on 2025-03-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.