Vagus Nerve Stimulation to Treat Moderate Traumatic Brain Injury

NCT02974959 | Completed Phase 1 DMC

• 1 other identifier: HSR 16-4171
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Traumatic Brain Injury; Acute Brain Injuries

Outcome Measures

Primary Outcomes (1)

• Safety/bradycardia

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

  18 weeks

Secondary Outcomes (3)

• Efficacy-cognition

  initial visit, 2 weeks, 6 weeks, 12 weeks, 18 weeks

• Efficacy-eye tracking

  initial visit, 2 weeks, 6 weeks, 12 weeks, 18 weeks

• Efficacy-serum biomarkers

  initial visit, 2 weeks, 6 weeks, 12 weeks, 18 weeks

Study Arms (2)

gammaCore active device

EXPERIMENTAL

Patients in this arm will be using an active device which delivers a treatment dose of current to the vagus nerve twice daily for 120 seconds

Device: gammaCore active device

gammaCore Sham device

SHAM COMPARATOR

Patients in this arm will be using a sham device which does not deliver a treatment dose of current, but will deliver enough current to cause tingling on the skin.

Device: gammaCore sham device

Interventions

gammaCore active device 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.

gammaCore active device

gammaCore sham device 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.

gammaCore Sham device

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written Informed Consent obtained by Subject or Subject's proxy.
• Is between the ages of 18 and 60 years, male or female.
• Meets the criteria of the Head Injury Interdisciplinary Special Interest Group of the American Congress of Rehabilitation Medicine, which defines a head injury as a traumatically induced physiologic disruption of brain function, as manifested by one of the following:
• Any period of loss of consciousness (LOC),
• Any loss of memory for events immediately before or after the accident,
• Any alteration in mental state at the time of the accident,
• Focal neurologic deficits, which may or may not be transient.
• Meets the criteria for moderate TBI as defined by the Head Injury Interdisciplinary Special Interest Group of the American Congress of Rehabilitation Medicine, which are as follows:
• Length of stay at least 48 hours,
• Glasgow Coma Scale (GCS score of 9-12 or higher)
• Operative intracranial lesion,
• Abnormal CT scan findings.
• Has had a craniotomy, but those with hydrocephalus or active intracranial pressure elevation will be excluded.
• Able to accurately communicate the sensation of amplitude of intensity by the stimulation treatment with the GammaCore device.
• Has a stable orthopedic or other traumatic body injury.

You may not qualify if:

• Has an active DNR/DNI (do not resuscitate/ do not intubate) request.
• Has dissent among family members / next of kin regarding level of care.
• Has a penetrating injury.
• Has concurrent active severe medical problems or conditions, which could prevent survival during the course of the study.
• Has pre-existing central nervous system disease or associated comorbidities that may not allow for an 18-week follow-up visit.
• Has an abscess, infection or lesion (including lymphadenopathy) at the gammaCore treatment site.
• Has known or suspected moderate to severe atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA).
• Has a clinically significant irregular heart rate or rhythm.
• Has uncontrolled hypertension (systolic bp \> 200 or diastolic bp \>100), recent (within the last 3 months) heart attack, recent (within the last 3 months) stroke, known aortic aneurysm, or congestive heart failure (CHF).
• Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
• Has a history of significant carotid endarterectomy, vagotomy, dysaesthesia or vascular neck surgery on either side of the neck.
• Has been implanted with metal cervical spine hardware.
• Has a recent or repeated history of syncope.
• Has a recent or repeated history of seizures.
• Has known clotting disorder or hemophilia

Sponsors & Collaborators

• CentraCare: lead
• ElectroCore INC: collaborator

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Uzma Samadani, MD, PhD

  Hennepin County Medical Center, Minneapolis

  PRINCIPAL INVESTIGATOR

• Thomas Bergman, MD

  Hennepin County Medical Center, Minneapolis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the study coordinator had access to the master list which noted whether the device was active or a sham. This information was not provided to or accessible by the participants, care providers, investigators, or outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: November 29, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: November 1, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

US (1)