Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT02791893
Status:
COMPLETED
Last Update Posted:
2021-05-03
First Post:
2016-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Vagus Nerve Stimulation: Treatment for Gulf Veterans With Gulf War Illness
Sponsor:
Benjamin Natelson
Organization:
Study Overview
Official Title:
Vagus Nerve Stimulation: A Non-invasive Treatment to Improve the Health of Gulf Veterans With Gulf War Illness
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 \[first time at Icahn School of Medicine at Mount Sinai. (ISMMS)\] Subjects randomized to either VNS device or inactive device.
Open Label Phase of Study All subjects receive the VNS device
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: