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NCT06540859 · ClinicalTrials.gov registry record · NA

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

A NA study of Spinal Cord Injuries, sponsored by University of Washington.

Recruiting
Registry status
NA
Development phase
26
Enrollment target
1
Study location

NCT06540859 is a NA study of Spinal Cord Injuries that is actively recruiting participants, run by University of Washington. The registered enrollment target is 26 participants, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06540859, a NA study of Spinal Cord Injuries, is actively recruiting participants, sponsored by University of Washington.

RECRUITING
Registry status
NA
Development phase
26 participants
Enrollment target
1
Study location

Study 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 resear

Conditions Studied

Spinal Cord Injuries

Interventions

  • DEVICE Sham Stimulation
  • DEVICE Transcutaneous Spinal Cord Stimulation

Study Locations (1)

Washington

  • University of Washington - Seattle

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2024-12-01
Est. Completion 2027-10
Phase NA

Sponsor

University of Washington

1,048 total trials

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What the Registry Record Tells You About NCT06540859

The ClinicalTrials.gov registry entry for NCT06540859 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (57% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Spinal Cord Injuries appearing as the primary indexed condition, and to 2 interventions - of which Sham Stimulation is the first listed.

NCT06540859 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT06540859 about?

NCT06540859 is a clinical study titled "Spinal Cord Stimulation for Autonomic Recovery in Inpatient Rehabilitation After Acute SCI". 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 an...

What is the current status of trial NCT06540859?

This trial is currently recruiting. It is a NA study. The enrollment target is 26 participants. The study started on 2024-12-01. Estimated completion is 2027-10.

What conditions does trial NCT06540859 study?

This clinical trial studies the following conditions: Spinal Cord Injuries.

What interventions are being tested in trial NCT06540859?

The interventions under investigation include: Sham Stimulation (DEVICE), Transcutaneous Spinal Cord Stimulation (DEVICE).

Who is sponsoring clinical trial NCT06540859?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06540859 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.