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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
27
Hand held device to use for self administration of vagus nerve stimulation.
Hand held device to use for self administration of simulated vagus nerve stimulation.
East Orange Veterans Administration Medical Center
East Orange, New Jersey, United States
Mount Sinai Beth Israel
New York, New York, United States
Pain and Fatigue Study Center - Beth Israel Medical Center
New York, New York, United States
Pain and Fatigue Study Center - Icahn School of Medicine at Mount Sinai
New York, New York, United States
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.
Time frame: 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.
Time frame: Baseline and 20 weeks
Patient Global Improvement of Change (PGIC)
PGIC is a 7-point scale used to quantify a patient's rating of overall improvement. Patients rate their change from 1 (no change or gotten worse) to 7 (considerable improvement). Higher scores indicate greater improvement since starting the intervention.
Time frame: 10 and 20 weeks
Physical Function Subscale From the Short Form Health Survey (SF-36)
A normalized indicator of physical functioning with a range from 0-100. Higher scores indicate fewer limitations to activity.
Time frame: 10 and 20 weeks
Number of Headache Days Collected From the Migraine Disability Assessment (MIDAS).
Participants are asked to indicate the number of days in the last 3 months during which they experienced a headache. If a headache lasted more than 1 day, they are instructed to count each day. Scores are expected between 0-90 with higher numbers corresponding to a greater number of headache days.
Time frame: 10 and 20 weeks
Depression Subscale From the Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item scale intended to quantify symptoms of depression and anxiety. Scores range from 0-21 on each subscale (Anxiety and Depression) with higher scores indicating a greater number of symptoms.
Time frame: 10 and 20 weeks
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