We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01260090
Recruitment Status : Unknown
Verified January 2011 by VA New York Harbor Healthcare System.
Recruitment status was:  Recruiting
First Posted : December 15, 2010
Last Update Posted : August 10, 2011
Sponsor:
Information provided by:
VA New York Harbor Healthcare System

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Minimally Conscious States Due to Traumatic Brain Injury Persistently Vegetative States Due to Traumatic Brain Injury Device: Vagus nerve stimulation; Device: No stimulation Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vagus Nerve Stimulation to Augment Recovery From Minimally Conscious or Persistently Vegetative States After Traumatic Brain Injury
Study Start Date : January 2011
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Sham Comparator: No Stimulation Device: No stimulation
Vagus nerve stimulation



Primary Outcome Measures :
  1. JFK Coma Recovery Scale [ Time Frame: every 3 months for 18 months ]

Secondary Outcome Measures :
  1. FIM plus FAM [ Time Frame: every 3 months for 18 months ]
  2. functional MRI [ Time Frame: every 3 months for 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260090


Contacts
Contact: Uzma Samadani, MD PhD 212 686 7500 ext 6857 uzma.samadani@va.gov

Locations
United States, New York
Manhattan Va NYHHCS Recruiting
New York, New York, United States, 10010
Contact: Uzma Samadani, MD PhD    212-686-7500 ext 3665    uzma.samadani@va.gov   
Sponsors and Collaborators
VA New York Harbor Healthcare System

Responsible Party: Uzma Samadani, MD PhD, VA NYHHCS
ClinicalTrials.gov Identifier: NCT01260090     History of Changes
Other Study ID Numbers: B7301P
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: August 10, 2011
Last Verified: January 2011

Keywords provided by VA New York Harbor Healthcare System:
Minimally conscious states
Persistently vegetative states
Traumatic brain injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Damage, Chronic
Persistent Vegetative State
Central Nervous System Diseases
Nervous System Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms