Migraine
Conditions
Keywords
vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, migraine, non invasive, gammacore
Brief summary
The purpose of this pilot study is to assess feasibility and clarify the design of future study(ies) to support marketing approval of the GammaCore™ device for the treatment and/or prevention of migraine symptoms.
Interventions
DEVICEn-VNS
Sponsors
ElectroCore INC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Is between the ages of 18 and 55 years. * Has been previously diagnosed as suffering from migraine, in accordance with the ICHD-2 Classification criteria (2nd), with or without aura. * Experiences at least 2 migraines per month, but less than 15 headache days per month (over the last 3 months). * Has age of onset of migraine less than 50 years old. * Is able to give written Informed Consent
Exclusion criteria
* Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma. * Has a lesion (including lymphadenopathy) at the GammaCore™ treatment site. * Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), coronary artery disease or recent myocardial infarction. * Has a history or baseline ECG that identifies the presence of a clinically significant unstable cardiac arrhythmia, second degree heart block type II, history of ventricular tachycardia or ventricular fibrillation, or known cardiac syndromes that may be associated with increased risk of sudden death in otherwise healthy people. * Has had a previous bilateral or right cervical vagotomy. * Has a clinically significant irregular heart rate or rhythm. * Has uncontrolled high blood pressure. * Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant. * Has a history of carotid endarterectomy or vascular neck surgery on the right side. * Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore™ stimulation site. * Has a recent or repeated history of syncope. * Has a recent or repeated history of seizure. * Has a history or suspicion of narcotic abuse. * Takes medication for acute headaches more than 10 days per month. * Is pregnant, nursing, thinking of becoming pregnant in the next 3 months, or of childbearing years and is unwilling to use an accepted form of birth control. * Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days. * Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner). * Is a relative of or an employee of the investigator or the clinical study site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Number of Participants With Adverse Effects | End of Study - 7 weeks | The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Headache Pain From Baseline to 120 Minutes | 120 minutes | Headache was measured on a 4 point scale where 0 = no pain, 1 = mild, 2 = moderate, 3 = severe pain at baseline (start of attack), 5, 15, 30, 45, 60, 90 and 120 minutes. Data presented shows the average change from baseline to 120 minutes |
| Change in Photophobia (Visual) From Baseline to 120 Minutes | Base line and 120 minutes | Presence of photophobia (yes or no) was captured at baseline and 120 minutes. |
| Change in Phonophobia (Auditory) From Baseline to 120 Minutes | Baseline and 120 minutes | Presence of phonophobia (yes or no) was captured at baseline and 120 minutes. |
| Mean Change in Nausea From Baseline to 120 Minutes | Baseline 120 minutes | Nausea was captured in the diary and measured on a 4 point scale, where 0 = no nausea, 1 = mild, 2 = moderate and 3 = severe nausea, at baseline and 120 minutes. |
| Mean Change in Functional Disability | Baseline and 120 minutes | Functional disability was captured in the diary and measured on a 4 point scale, where 0 = no disability, able to function normally and where 3 = performance of daily activities severely impaired, measured at baseline and 120 minutes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active n-VNS active therapy | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Active |
|---|---|
| Age, Continuous | 38.5 years |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 6 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 19 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 13 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Safety - Number of Participants With Adverse Effects
The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.
Time frame: End of Study - 7 weeks
Population: Randomized population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active | Safety - Number of Participants With Adverse Effects | Unanticipated Adverse Effects | 0 Participants |
| Active | Safety - Number of Participants With Adverse Effects | Anticipated Adverse Effects | 13 Participants |
Secondary
Change in Phonophobia (Auditory) From Baseline to 120 Minutes
Presence of phonophobia (yes or no) was captured at baseline and 120 minutes.
Time frame: Baseline and 120 minutes
Population: Randomized population. Data was missing for 3 patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active | Change in Phonophobia (Auditory) From Baseline to 120 Minutes | Migraine attacks with phonophobia at baseline | 32 migraines with phonophobia |
| Active | Change in Phonophobia (Auditory) From Baseline to 120 Minutes | Migraine attacks with phonophobia at 120 minutes | 15 migraines with phonophobia |
Secondary
Change in Photophobia (Visual) From Baseline to 120 Minutes
Presence of photophobia (yes or no) was captured at baseline and 120 minutes.
Time frame: Base line and 120 minutes
Population: Randomized population. Data was missing for 3 patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active | Change in Photophobia (Visual) From Baseline to 120 Minutes | Migraine attacks with photophobia at baseline | 53 migraines with photophobia |
| Active | Change in Photophobia (Visual) From Baseline to 120 Minutes | Migraine attacks with photophobia at 120 minutes | 37 migraines with photophobia |
Secondary
Mean Change in Functional Disability
Functional disability was captured in the diary and measured on a 4 point scale, where 0 = no disability, able to function normally and where 3 = performance of daily activities severely impaired, measured at baseline and 120 minutes.
Time frame: Baseline and 120 minutes
Population: Randomized population. Data was missing for 3 patients
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active | Mean Change in Functional Disability | Mean disability score at baseline | 1.07 units on a scale |
| Active | Mean Change in Functional Disability | Mean disability score at 120 minutes | 0.77 units on a scale |
Secondary
Mean Change in Headache Pain From Baseline to 120 Minutes
Headache was measured on a 4 point scale where 0 = no pain, 1 = mild, 2 = moderate, 3 = severe pain at baseline (start of attack), 5, 15, 30, 45, 60, 90 and 120 minutes. Data presented shows the average change from baseline to 120 minutes
Time frame: 120 minutes
Population: Randomized population. 2 subjects were excluded from the analysis due to protocol deviations
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active | Mean Change in Headache Pain From Baseline to 120 Minutes | Mean baseline pain score | 1.84 units on a scale |
| Active | Mean Change in Headache Pain From Baseline to 120 Minutes | Mean 120 minutes pain score | 1.20 units on a scale |
Secondary
Mean Change in Nausea From Baseline to 120 Minutes
Nausea was captured in the diary and measured on a 4 point scale, where 0 = no nausea, 1 = mild, 2 = moderate and 3 = severe nausea, at baseline and 120 minutes.
Time frame: Baseline 120 minutes
Population: Randomized population. Data was missing for 3 patients
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active | Mean Change in Nausea From Baseline to 120 Minutes | Nausea severity at baseline | 0.42 units on a scale |
| Active | Mean Change in Nausea From Baseline to 120 Minutes | Nausea severity at 120 minutes | 0.34 units on a scale |