Non-invasive Neurostimulation for the Relief of Migraine

NCT03410628 | Terminated Results

• 1 other identifier: M-SA-01
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this feasibility study is to gather preliminary information on the safety and effectiveness of patient self-administration of a noninvasive neurostimulation of the vagus nerve using the GammaCore device for the treatment of pain and allodynia symptoms associated with acute migraine in adults.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Safety - Number of Participants With Adverse Events

  Safety was assessed by collecting adverse events for the duration of the study

  Up to 4 months

Secondary Outcomes (1)

• Change in Headache Pain Severity From Baseline to 120 Minutes for First Treated Migraine Attack

  120 minutes

Study Arms (1)

gammaCore Active Device

EXPERIMENTAL

open label

Device: gammaCore

Interventions

gammaCore DEVICE

Non-invasive vagal nerve stimulator

gammaCore Active Device

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Is between the ages of 18 and 55 years.
• Has been previously diagnosed as suffering from migraine, in accordance with the IHS-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 distinguish migraines from other headaches (e.g. tension headache).
• Agrees to withhold usual migraine medications until after stimulation treatment with the GammaCore device.
• Agrees to follow all of the requirements of the study, including follow-up visit requirements, and is sufficiently trained with respect to the operation of the GammaCore device and the data collection procedures.
• Agrees to report use of the GammaCore device, study data, and any adverse device effects to the study center within 24 hours of treatment(s), and agrees to schedule an office visit 4-10 days after the third and final treatment, or when 6 weeks has passed, whichever comes first.
• Is able to give written Informed Consent, or his/her legally authorized representative is available to give written Informed Consent.

You may not qualify if:

• Has a history of aneurysm, bleed, brain tumors or significant head trauma.
• Has a lesion (including lymphadenopathy) at the therapy head placement site.
• Has known or suspected severe atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA) or congestive heart failure (CHF).
• Has a history of epilepsy.
• Has suspected or confirmed sepsis, or infection.
• Has a clinically significant irregular heart rate or rhythm.
• Is receiving pressors to maintain blood pressure.
• Has a history of syncope.
• 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 been implanted with metal cervical spine hardware.
• Has a history of carotid endarterectomy or vascular neck surgery on the right side.
• Has a condition that would interfere with headache pain self-assessment.
• Is pregnant or is thinking of becoming pregnant in the next 6 weeks.
• Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
• Takes medication for acute headaches more than 10 days per month.

Sponsors & Collaborators

• ElectroCore INC: lead

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Clinical Affairs
• Organization: electroCore Inc.

clinical@electrocorellc.com

+1 973 355 6683

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: January 25, 2018
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 26, 2018
• Results First Posted: July 26, 2018

Record last verified: 2018-07