Vagus Nerve Stimulation to Augment Recovery From Minimally Conscious or Persistently Vegetative States After Traumatic Brain Injury

April 25, 2023 updated by: Uzma Samadani, VA New York Harbor Healthcare System

Traumatic brain injury has a high morbidity and mortality in both civilian and military populations. Blast and other mechanisms of traumatic brain injury damage the brain by causing neurons to disconnect and atrophy. Such traumatic axonal injury can lead to persistently vegetative and minimally conscious states, for which extremely limited treatment options exist, including physical, occupational, speech and cognitive therapies.

More than 50,000 patients have received vagus nerve stimulation for epilepsy and depression. In addition to decreased seizure frequency and severity, patients report enhanced mood, reduced daytime sleepiness independent of seizure control, increased slow wave sleep, and improved cognition, memory, and quality of life.

The purpose of this study is to demonstrate objective improvement in clinical outcome by placement of a vagus nerve stimulator in patients who are recovering from severe traumatic brain injury. Our hypothesis is that stimulation of the vagus nerve results in increased cerebral blood flow and metabolism in the forebrain, thalamus and reticular formation, which promotes arousal and improved consciousness, thereby improving outcome after traumatic brain injury resulting in minimally conscious or persistent vegetative states. If this study demonstrates that vagus nerve stimulation can safely and positively impact outcome, then a larger randomized prospective crossover trial will be proposed.

The investigators will achieve this objective by evaluating whether vagus nerve stimulation impacts clinical recovery from minimally conscious or persistent vegetative states caused by traumatic brain injury as assessed by the FIM™ instrument and Functional Assessment Measure (FIM+FAM) as well as the JFK Coma Recovery Scale Score. The investigators will also evaluate whether vagus nerve stimulation alters resting and activational functional MRI.

Twelve patients will be enrolled in this initial crossover pilot study. These patients will have sustained a severe traumatic brain injury (Disability Rating Scale score of 22 to 29) more than twelve months from starting the study, and have no other concurrent active severe medical problems. Baseline EEG and magnetic resonance imaging (MRI) will be performed prior to left vagus nerve stimulation implantation. Patients will be randomized to alternating three month periods with the device on or off. Outcomes will be assessed at three month intervals with the FIM™ instrument and Functional Assessment Measure (FIM+FAM) and JFK Coma Recovery Scale by a neuropsychologist blinded to the status of the device. Outcomes will also be assessed using quantitative eye movement tracking and functional magnetic resonance imaging. Patients will cross over every 3 months and be followed for at least 18 months.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • Manhattan Va NYHHCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 60
  • greater than 12 months from a moderate to severe traumatic brain injury
  • Disability Rating Scale score of 18 to 29
  • with or without concurrent seizure activity
  • Eligible for care in the VA system

Exclusion Criteria:

  • Anoxic mechanism of brain injury (eg prolonged arrest)
  • Untreated hydrocephalus
  • Elevated intracranial pressure
  • Systemic issues precluding surgery or 18 months survival
  • Traumatic injuries precluding surgery or 18 months survival
  • Retained shrapnel or other metal contraindicating MRI
  • Prior vagotomy
  • Sleep apnea
  • Myocardial infarction, arrhythmia
  • History of cardiac conduction abnormality
  • Pregnancy or intent to become pregnant
  • Pre-existing CNS disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: No Stimulation
Device: No stimulation
Vagus nerve stimulation
Experimental: Vagus Nerve Stimulation

Name of the Device:

We will use the PMA approved version of the NCP System, including the NCP Generator (model 103), NCP Programming Wand (model 201), NCP Programming Software (model 250v7.1), NCP Lead (model 304), NCP Tunneling Tool (model 402) and the Patient Magnet (model 220).

FDA Facility Registration Number: 1644487
Device: Vagus nerve stimulation;

Name of the Device:

We will use the PMA approved version of the NCP System, including the NCP Generator (model 103), NCP Programming Wand (model 201), NCP Programming Software (model 250v7.1), NCP Lead (model 304), NCP Tunneling Tool (model 402) and the Patient Magnet (model 220).

FDA Facility Registration Number: 1644487

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
JFK Coma Recovery Scale
Time Frame: every 3 months for 18 months
every 3 months for 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
FIM plus FAM
Time Frame: every 3 months for 18 months
every 3 months for 18 months
functional MRI
Time Frame: every 3 months for 18 months
every 3 months for 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA New York Harbor Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

December 14, 2010

First Posted (Estimate)

December 15, 2010

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B7301P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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