Pain Clinical Trial - Vagus Nerve Stimulation: Treatment for Gulf Veterans

Status Completed

Clinical Trial 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.

Clinical Trial 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 Icahn School of Medicine at Mount Sinai. (ISMMS)] Subjects randomized to either VNS device or inactive device. Open Label Phase of Study All subjects receive the VNS device ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02791893
Study type	Interventional
Source	Icahn School of Medicine at Mount Sinai
Contact
Status	Completed
Phase	N/A
Start date	March 21, 2017
Completion date	April 15, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms