Adults 42 to 80, any sex, with Pain or Migraine. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Visual Analog Scale (VAS) to Assess Change of Widespread PainPrimary· 10 and 20 weeks
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 weeks
Group
Value
95% CI
VNS Device
4.70
± 2.41
Inactive Device
5.40
± 2.27
20 weeks
Group
Value
95% CI
VNS Device
5.43
± 2.07
Inactive Device
3.56
± 1.40
Patient Global Improvement of Change (PGIC)Secondary· 10 and 20 weeks
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.
10 weeks
Group
Value
95% CI
VNS Device
4.00
± 2.06
Inactive Device
3.11
± 1.90
20 weeks
Group
Value
95% CI
VNS Device
3.71
± 1.98
Inactive Device
5.37
± 1.41
Physical Function Subscale From the Short Form Health Survey (SF-36)Secondary· 10 and 20 weeks
A normalized indicator of physical functioning with a range from 0-100. Higher scores indicate fewer limitations to activity.
10 weeks
Group
Value
95% CI
VNS Device
65.50
± 19.78
Inactive Device
55.56
± 24.81
20 weeks
Group
Value
95% CI
VNS Device
60.71
± 32.97
Inactive Device
56.25
± 27.35
Number of Headache Days Collected From the Migraine Disability Assessment (MIDAS).Secondary· 10 and 20 weeks
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.
10 weeks
Group
Value
95% CI
VNS Device
4.10
± 6.76
Inactive Device
13.78
± 23.49
20 weeks
Group
Value
95% CI
VNS Device
6.29
± 10.63
Inactive Device
14.25
± 25.58
Depression Subscale From the Hospital Anxiety and Depression Scale (HADS)Secondary· 10 and 20 weeks
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.
10 weeks
Group
Value
95% CI
VNS Device
9.00
± 2.26
Inactive Device
10.11
± 1.05
20 weeks
Group
Value
95% CI
VNS Device
7.50
± 1.05
Inactive Device
9.75
± 2.25
Visual Analog Scale (VAS) to Assess Change of Widespread PainPrimary· Baseline and 20 weeks
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
Group
Value
95% CI
VNS Device
6.18
± 0.82
20 weeks
Group
Value
95% CI
VNS Device
4.43
± 1.94
Adverse events — posted to ClinicalTrials.gov
Time frame: Patients were asked to provide reports on adverse events after the first week of the blinded phase (Week 1), at the end of the blinded phase (Week 11), and in the final week of the open label phase (Week 20). Adverse event monitoring for the sample took place over the course of 3 years (March, 2017 - March 2020)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Benjamin Natelson
Last refreshed: 3 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02791893.