Actively Recruiting

Phase Not Applicable
Age: 21Years - 65Years
All Genders
NCT06540859

Spinal Cord Stimulation for Autonomic Recovery in Inpatient Rehabilitation After Acute SCI

Led by University of Washington · Updated on 2025-03-27

26

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

T

The Craig H. Neilsen Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Spinal Cord Stimulation for Autonomic Recovery in Inpatient Rehabilitation After Acute SCI

Who Can Participate

Age: 21Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 21 and 65 years
  • Spinal cord injury at or above the T6 spinal segment
  • Admitted to inpatient rehabilitation or discharged within 4 months of injury onset
  • American Spinal Injury Association Impairment Scale (AIS) grade A-D
  • Stable medical condition allowing participation in testing
  • Willing and able to attend all clinic visits and procedures
  • Able to understand and complete questionnaires in English
  • No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection interfering with testing
  • Not currently pregnant and not intending to become pregnant during the study
  • Volunteering to participate
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Autoimmune cause of spinal cord dysfunction or injury
  • History of other neurological diseases such as stroke or multiple sclerosis
  • Rheumatic diseases like rheumatoid arthritis or lupus
  • Dependence on a ventilator
  • Significant unmanaged depression or ongoing alcohol/drug abuse
  • Use of medications or treatments that make participation unsafe
  • Presence of an intrathecal baclofen pump
  • Cardiovascular, respiratory, bladder, or kidney disease unrelated to spinal cord injury or presence of hydronephrosis or obstructive kidney stones
  • Severe acute medical issues that could affect participation, such as infections or unstable diabetes
  • Presence of pacemakers, stimulators, medication pumps in the trunk, deep brain stimulators, or metal implants in the head
  • Being a member of the investigational team or immediate family
  • History of severe allergies not treatable with antihistamines
  • Malabsorption syndrome, primary hyperthyroidism, or hypogonadism
  • History of seizures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Washington

Seattle, Washington, United States, 98195

Actively Recruiting

Loading map...

Research Team

S

Soshi Samejima, DPT, PhD

CONTACT

K

Katie Singsank, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here