Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting NA study of Spinal Cord Injuries, sponsored by University of Washington.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Sham Stimulation
- DEVICE Transcutaneous Spinal Cord Stimulation
Study Locations (1)
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2024-12-01 |
| Est. Completion | 2027-10 |
| Phase | NA |
What NCT06540859 shows while recruiting
NCT06540859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (57% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injuries
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06540859's enrollment target sits among peer trials
26 108th of 202 higher than 94 of 202 other Spinal Cord Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
RECRUITING · NA
-
Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function After Spinal Cord Injury
RECRUITING · NA
-
Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
RECRUITING · NA
-
Transcutaneous Spinal Stimulation and Exercise for Locomotion
RECRUITING · NA
-
HAPPINESS: cHAnging the Perceived Pain INtEnSity in Populations With Spinal Cord Injury and With Health Disparities: A Feasibility Study
RECRUITING · NA
-
Dosing rTMS for Depression Post-SCI
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02646475 · 26 participants · Phase 1
Metabolic Effects of Angiotensin-(1-7)
- NCT03603223 · 26 participants · Phase 2
Pembrolizumab in Treating Participants With Leukoplakia
- NCT04063592 · 26 participants · NA
AMI Construction in Lower Extremity Residual Limbs
- NCT04906460 · 26 participants · Phase 1
Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT06358040 · started 2026-10 · NA
Opioid Dispenser for Microdiscectomy/Laminectomy