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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by VA New York Harbor Healthcare System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
VA New York Harbor Healthcare System
ClinicalTrials.gov Identifier:
NCT01260090
First received: December 14, 2010
Last updated: August 9, 2011
Last verified: January 2011
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vagus Nerve Stimulation to Augment Recovery From Minimally Conscious or Persistently Vegetative States After Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by VA New York Harbor Healthcare System:

Primary Outcome Measures:
  • JFK Coma Recovery Scale [ Time Frame: every 3 months for 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • FIM plus FAM [ Time Frame: every 3 months for 18 months ] [ Designated as safety issue: Yes ]
  • functional MRI [ Time Frame: every 3 months for 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: January 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Uzma Samadani, MD PhD, VA NYHHCS
ClinicalTrials.gov Identifier: NCT01260090     History of Changes
Other Study ID Numbers: B7301P
Study First Received: December 14, 2010
Last Updated: August 9, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 22, 2014