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Vagus Nerve Stimulation: Treatment for Gulf Veterans With Gulf War Illness

This study is currently recruiting participants.
Verified October 2017 by Benjamin Natelson, Beth Israel Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02791893
First Posted: June 7, 2016
Last Update Posted: October 27, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Benjamin Natelson, Beth Israel Medical Center
  Purpose

The researchers propose studying Gulf veterans with Gulf War Illness (GWI), characterized by a problem with widespread pain. Besides their pain, the researchers will also assess the effect of vagus nerve stimulation (VNS) in alleviating migraine headache, another complaint of Gulf veterans, which is common in the presence of widespread pain. Importantly, the researchers are partnering with a company that has made a hand-held device that allows for stimulation of the vagus nerve without the need for surgery; it works by the patient putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day; it is then inactive until the next day. The fact that this device can be used without surgery and is non-invasive makes it extremely practical for use.

After collecting pre-treatment measurement of pain severity and headache severity, veterans will receive either the actual active VNS device or an inactive device, which does not stimulate the nerve. Veterans will use their device for ten weeks - providing similar information periodically over this period by responding to questions about the severity of their pain and headaches, They will then return to the Center for the final phase of the study where all veterans will receive active devices. Ten weeks later, they will return to the Center to provide information to allow the investigators to gain further knowledge as to the effectiveness of actual VNS in relieving pain - both throughout the body and in the head.


Condition Intervention
Pain Migraine Device: VNS device Device: Inactive device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vagus Nerve Stimulation: A Non-invasive Treatment to Improve the Health of Gulf Veterans With Gulf War Illness

Further study details as provided by Benjamin Natelson, Beth Israel Medical Center:

Primary Outcome Measures:
  • Visual Analog Scale (VAS) to assess change of widespread pain [ Time Frame: baseline, at 10 and 20 weeks ]
    Visual analog scale, ranging from 0 [none] to 10 [most severe possible] for widespread pain


Secondary Outcome Measures:
  • Patient Global Improvement of Change (PGIC) [ Time Frame: at 10 and 20 weeks ]
    PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change from 1 to 7 (no change or gotten worse to considerable improvement).

  • Short Form-36 (SF-36) [ Time Frame: Baseline, at 10 and 20 weeks ]
    Change in physical function subscale of the SF-36, a questionnaire assessing health related quality of life, scored from 0 to 100 (max disability to no disability).

  • Number of migraine headache days [ Time Frame: Baseline and at 20 weeks ]
    Change in the number of migraine headache days at 20 weeks as compared to baseline


Estimated Enrollment: 40
Actual Study Start Date: March 21, 2017
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VNS device
Vagus Nerve Stimulation (VNS) hand held device - subjects to utilize the VNS hand held device for 20 weeks total, putting it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second periods three times a day. The device is programmed to deliver only 6 bouts of stimulation per day - one to each side of the neck three times a day
Device: VNS device
Hand held device to use for self administration of vagus nerve stimulation.
Other Name: Non-InvasiveVagus Nerve Stimulation (nVNS) Therapy
Placebo Comparator: Inactive device
Inactive hand held device - subjects to utilize the inactive device for 10 weeks and then will receive the VNS device for the next 10 weeks.
Device: VNS device
Hand held device to use for self administration of vagus nerve stimulation.
Other Name: Non-InvasiveVagus Nerve Stimulation (nVNS) Therapy
Device: Inactive device
Hand held device to use for self administration of simulated vagus nerve stimulation.

Detailed Description:

The Three Phases of the Study

Subject Identification Phase of Study face to face visit at the War Related Illness & Injury Study Center at the East Orange Veterans Administration Medical Center (EOVAMC).

Blinded Phase of Study Office Visit [first time at Mount Sinai Beth Israel. (MSBI)] Subjects randomized to either VNS device or inactive device.

Open Label Phase of Study All subjects receive the VNS device

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   42 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible for enrollment in the Study, patients must meet all of the following criteria:

  • Patient is a veteran of the 1990-91 Gulf War, aged at least 42 years old
  • Patient fulfills Kansas criteria for Gulf War Illness including endorsement of musculoskeletal pain at moderate or severe intensities. This means patient has endorsed symptoms in at least 3 of the following problem areas: Fatigue/sleep; musculoskeletal pain; cognitive and mood; Gastrointestinal; respiratory; skin.
  • Patient has widespread pain as evidenced by endorsement of pain in at least 3 bodily quadrants plus in the axial skeleton
  • Patient has a median 24 hour widespread pain score of at least 5 on a 0 to 10 VAS with data taken on five days
  • To be considered as having migraine, the patient must fulfill International Headache Society (IHS) criteria, and it should have been present for at least one year prior to entry into the study
  • Patient agrees to use the study device as intended, follow all of the requirements of the study including completion of diary after each self-treatment, follow-up visit requirements, complete self assessment questionnaires as scheduled, and report any adverse device effects to the study center within 24 hours of such adverse device effect.
  • Patient is able to provide written Informed Consent.

Exclusion Criteria:

Patients with any of the following will not be eligible for enrollment:

  • Patient has a history of intracranial aneurysm, intracranial hemorrhage, brain tumor or significant head trauma.
  • Patient has in the opinion of the investigator a clinically relevant structural abnormality at the gammaCore-R treatment site (e.g., neoplasm, lymphadenopathy, previous surgery, neoplasm or abnormal anatomy).
  • Patient has pain at the gammaCore treatment site (eg, dysesthesia, neuralgia, cervicalgia).
  • Patient has other significant pain problem (e.g., cancer pain or other head or facial pain disorder) that in the opinion of the investigator may confound the study assessments.
  • Patient has known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure (CHF), significant premature ventricular contraction) or a history of cardiac arrhythmia.
  • Patient has known or suspected cerebrovascular disease (e.g., prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery).
  • Patient's electrocardiogram shows evidence of heart disease or arrhythmia including an abnormal baseline ECG (e.g. second and third degree heart block, prolonged QT interval (corrected QT (QTcB) interval >470 msec for women and > 450 for men), atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction) or a history of cardiac arrhythmia.
  • Patient has had a previous cervical vagotomy.
  • Patient has uncontrolled high blood pressure (systolic bp >160, or diastolic bp > 100) after 3 measurements within 24 hours.
  • Patient is currently implanted with an electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant, Sphenopalatine ganglion stimulator or Occipital nerve stimulator).
  • Patient has been implanted with metal cervical spine hardware or has a metallic implant near the gammaCore-R stimulation site.
  • Patient has a history of significant syncope within the last 5 years.
  • Patient has a history of non-epileptic or epileptic seizures within the last 5 years.
  • Patient, in the opinion of the investigator, has a known history or suspicion of substance abuse or addiction within the last 5 years.
  • Patient, in the opinion of the investigator/research staff, the patient is incapable of operating the gammaCore-R device as intended and performing the data collection procedures.
  • Patient has a psychiatric or cognitive disorder and/or behavioral problem which in the opinion of the clinician may interfere with the study (e.g. Bipolar Disorder, depressive disorder with psychotic features, Specific Phobia, Acute Stress Disorder).
  • Patient is pregnant or thinking of becoming pregnant in the next 6 months, or is of childbearing years and unwilling to use an accepted form of birth control or is unwilling to undergo pregnancy testing.
  • Patient is nursing
  • Patient has undergone botulinum toxin (BOTOX) injections of the head and/or neck in the last 3 months.
  • Patient is participating or has participated in any other therapeutic clinical investigation during the last 30 days.
  • Patient belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner).
  • Patient has evidence of suicidality based on the Columbia Suicide Screening test
  • Patient has previously used a gammaCore device.
  • Patient is the spouse or housemate of someone else in the trial.
  Contacts and Locations
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): NCT02791893


Contacts
Contact: Benjamin H Natelson, MD 212-844-6665 Benjamin.Natelson@mountsinai.org

Locations
United States, New Jersey
East Orange Veterans Administration Medical Center Recruiting
East Orange, New Jersey, United States, 07018
Contact: Michelle Deluca       Michelle.Deluca@va.gov   
Principal Investigator: Benjamin H Natelson, MD         
Lyons Campus of the VA New Jersey Health Care System Withdrawn
Lyons, New Jersey, United States, 07939
United States, New York
Mount Sinai Beth Israel Recruiting
New York, New York, United States, 10003
Contact: Sarah Khan    212-844-8618    sarah.khan1@mountsinai.org   
Principal Investigator: Benjamin H Natelson, MD         
Pain and Fatigue Study Center - Beth Israel Medical Center Recruiting
New York, New York, United States, 10014
Contact: Sarah Khan    212-844-8618    sarah.khan1@mountsinai.org,   
Principal Investigator: Benjamin Natelson, MD         
Sponsors and Collaborators
Benjamin Natelson
Investigators
Study Director: Benjamin H Natelson, MD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Benjamin Natelson, Professor of Neurology, Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT02791893     History of Changes
Other Study ID Numbers: GCO 16-0350
First Submitted: May 30, 2016
First Posted: June 7, 2016
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No