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NCT02974959 · ClinicalTrials.gov registry record · Phase 1

Vagus Nerve Stimulation to Treat Moderate Traumatic Brain Injury

A Phase 1 study of Traumatic Brain Injury and Acute Brain Injuries, sponsored by CentraCare.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target
1
Study location

NCT02974959 is a Phase 1 study of Traumatic Brain Injury and Acute Brain Injuries that has completed, run by CentraCare. The registered enrollment target is 14 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02974959, a Phase 1 study of Traumatic Brain Injury and Acute Brain Injuries, has completed, sponsored by CentraCare.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target
1
Study location

Study Summary

The purpose of this single-center, prospective, randomized (1:1), double-blind, sham-controlled parallel-arm pilot study is to provide initial evidence of use of the noninvasive vagus nerve stimulator for treatment in patients recovering from concussion and moderate traumatic brain injury to improve clinical recovery. The study compares the safety and effectiveness of an active gammaCore treatment against a sham treatment.

Conditions Studied

Traumatic Brain Injury Acute Brain Injuries

Interventions

  • DEVICE gammaCore active device
  • DEVICE gammaCore sham device

Study Locations (1)

Minnesota

  • Hennepin County Medical Center - Minneapolis

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2016-10
Est. Completion 2020-11
Phase Phase 1

Sponsor

CentraCare

3 total trials

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What the Registry Record Tells You About NCT02974959

The ClinicalTrials.gov registry entry for NCT02974959 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (95% lower). The listed sponsor is CentraCare, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which gammaCore active device is the first listed.

NCT02974959 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT02974959 about?

NCT02974959 is a clinical study titled "Vagus Nerve Stimulation to Treat Moderate Traumatic Brain Injury". The purpose of this single-center, prospective, randomized (1:1), double-blind, sham-controlled parallel-arm pilot study is to provide initial evidence of use of the noninvasive vagus nerve stimulator for treatment in patients recovering from concussion and moderate traumatic brain injury to improve...

What is the current status of trial NCT02974959?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2016-10. Estimated completion is 2020-11.

What conditions does trial NCT02974959 study?

This clinical trial studies the following conditions: Traumatic Brain Injury, Acute Brain Injuries.

What interventions are being tested in trial NCT02974959?

The interventions under investigation include: gammaCore active device (DEVICE), gammaCore sham device (DEVICE).

Who is sponsoring clinical trial NCT02974959?

This trial is sponsored by CentraCare, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02974959 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.