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Vagus Nerve Stimulation to Treat Moderate Traumatic Brain Injury

NCT02974959 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-02-04

No results posted yet for this 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

Interventions

DEVICE

gammaCore active device

The nVNS therapy will be performed using the gammaCore-R (electroCore LLC, NJ), which is an external hand-held vagal nerve stimulator. The gammaCore-R produces a low voltage electric signal consisting of five 5000 Hz pulses that are repeated at a rate of 25 Hz. It allows for a 120 second stimulation session. The stimulation will occur twice daily, one time in the morning and one time in the evening. This should be done as close to 12 hours apart as possible and should occur twice daily for the entire 12 week study period.

DEVICE

gammaCore sham device

The sham device appears identical to the gammaCore but does not provide a frequency of stimulation powerful enough to stimulate either efferent or afferent fibers of the vagus nerve. However, it does supply a low frequency current which will cause a tingling of this skin to improve blinding of the patients.

Sponsors & Collaborators

  • ElectroCore INC

    collaborator INDUSTRY

  • CentraCare

    lead OTHER

Principal Investigators

  • Uzma Samadani, MD, PhD · Hennepin County Medical Center, Minneapolis

  • Thomas Bergman, MD · Hennepin County Medical Center, Minneapolis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2020-06-30
Completion
2020-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02974959 on ClinicalTrials.gov