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NCT06313515 · ClinicalTrials.gov registry record · NA

Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCI

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

Recruiting
Registry status
NA
Development phase
16
Enrollment target
1
Study location

NCT06313515 is a NA study of Spinal Cord Injuries that is actively recruiting participants, run by University of Washington. The registered enrollment target is 16 participants, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06313515, a NA study of Spinal Cord Injuries, is actively recruiting participants, sponsored by University of Washington.

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

Study Summary

Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic functions like blood pressure, breathing, and heart rate. This can also make it hard for those living with SCI to exercise or complete their usual daily activities. The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation (tSCS) for cardiovascular recovery in adults aged 21-65 following chronic motor-complete spinal cord injury (SCI) at or above the thoracic sixth spinal segment (≥T6). The main questions the study aims to answer are: * Conduct tSCS mapping to determine the most effective location and stimulation intensity for BP control in individuals with motor-complete SCI ≥ T6. * Evaluate the effects 8 weeks of targeted tSCS paired with arm-crank exercise compared to sham stimulation with exercise on improving cardiovascular function in individuals with motor-complete SCI ≥T6. * Evaluate the dosage-response of 8 weeks vs. 16 weeks of targeted tSCS paired with arm-crank exercise on cardiovascular function in individuals with motor-complete SCI ≥T6. * Explore the mechanisms involved in cardiovascular recovery with long-term tSCS paired with arm-crank exercise. Participants will: * Receive either transcutaneous spinal cord stimulation or "sham" spinal cord stimulation while exercising on an arm-crank bicycle in the first 8 weeks. * Come in for approximately 60 visits over a 6-month period. This includes 2, 8-week periods where the investigators will ask participants to come in 3x per week for spinal cord stimulation and exercise. * During assessment visits the researchers will perform a variety of exams including a neurologic, cardiovascular, pulmonary, physical, and autonomic exam, and will ask questions about quality of life and functioning. Researchers will compare those who receive tSCS and do moderate arm-crank exercise to those who receive a sham stimulation and

Conditions Studied

Spinal Cord Injuries

Interventions

  • OTHER Sham Stimulation
  • DEVICE Transcutaneous Spinal Cord Stimulation
  • BEHAVIORAL Arm-crank bike exercise

Study Locations (1)

Washington

  • University of Washington - Seattle

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2024-04-01
Est. Completion 2027-02-01
Phase NA

Sponsor

University of Washington

1,048 total trials

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What the Registry Record Tells You About NCT06313515

The ClinicalTrials.gov registry entry for NCT06313515 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (74% 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 3 interventions - of which Sham Stimulation is the first listed.

NCT06313515 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT06313515 about?

NCT06313515 is a clinical study titled "Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCI". Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic functions like blood pressure, breathing, and heart rate. This can also make it hard for those living with SCI to exercise or complete their usual daily activities. The goal of this randomized trial is to t...

What is the current status of trial NCT06313515?

This trial is currently recruiting. It is a NA study. The enrollment target is 16 participants. The study started on 2024-04-01. Estimated completion is 2027-02-01.

What conditions does trial NCT06313515 study?

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

What interventions are being tested in trial NCT06313515?

The interventions under investigation include: Sham Stimulation (OTHER), Transcutaneous Spinal Cord Stimulation (DEVICE), Arm-crank bike exercise (BEHAVIORAL).

Who is sponsoring clinical trial NCT06313515?

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

Where is trial NCT06313515 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.