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

NCT02791893 | Completed Results FDA Device

• 1 other identifier: GCO 16-0350
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Pain; Migraine

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS) to Assess Change of Widespread Pain

  Patients used the Pain Visual Analog Scale (0-10; 0=No pain, 10=Worst pain possible) to rate their average level of pain over the last 24 hours. The median value for each individual's ratings over 5 consecutive days immediately prior to the end of the intervention period was recorded and then the average was calculated for each group.

  10 and 20 weeks

• Visual Analog Scale (VAS) to Assess Change of Widespread Pain

  Patients used the Pain Visual Analog Scale (0-10; 0=No pain, 10=Worst pain possible) to rate their average level of pain over the last 24 hours. The median value for each individual's ratings over 5 consecutive days immediately prior to the end of the intervention period was recorded and then the average was calculated for each group.

  Baseline and 20 weeks

Secondary Outcomes (4)

• Patient Global Improvement of Change (PGIC)

  10 and 20 weeks

• Physical Function Subscale From the Short Form Health Survey (SF-36)

  10 and 20 weeks

• Number of Headache Days Collected From the Migraine Disability Assessment (MIDAS).

  10 and 20 weeks

• Depression Subscale From the Hospital Anxiety and Depression Scale (HADS)

  10 and 20 weeks

Study Arms (2)

VNS device

EXPERIMENTAL

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

Inactive device

PLACEBO COMPARATOR

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; Device: Inactive device

Interventions

VNS device DEVICE

Hand held device to use for self administration of vagus nerve stimulation.

Also known as: Non-InvasiveVagus Nerve Stimulation (nVNS) Therapy

Inactive device; VNS device

Inactive device DEVICE

Hand held device to use for self administration of simulated vagus nerve stimulation.

Inactive device

Eligibility Criteria

• Age: 42 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 visual analog scale (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benjamin Natelson: lead

Study Sites (4)

East Orange Veterans Administration Medical Center

East Orange, New Jersey, 07018, United States

Location

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

Pain and Fatigue Study Center - Beth Israel Medical Center

New York, New York, 10014, United States

Location

Pain and Fatigue Study Center - Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Pain; Migraine Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Benjamin Natelson
• Organization: Mount Sinai Beth Israel, New York, NY

Benjamin.Natelson@mountsinai.org

212-844-6768

Study Officials

• Benjamin H Natelson, MD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 7, 2016
• Study Start: March 21, 2017
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: May 3, 2021
• Results First Posted: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)