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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

We will evaluate for bradycardia after using the device at all time points using an EKG and heart rate variability (Beats/minute for each)

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
CentraCare

3 total trials

What the finished NCT02974959 record still lists

NCT02974959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (95% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Traumatic Brain Injury

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 NCT02974959's enrollment target sits among peer trials

14 161st of 171 higher than 10 of 171 other Traumatic Brain Injury trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Traumatic Brain Injury 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

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Related registry views

Source: ClinicalTrials.gov NCT02974959, the US trial registry maintained by the National Library of Medicine. NCT02974959 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.