Migraine Treatment With Nerivio Migra Neurostimulation Device

A Prospective, Randomized, Double-blind, Sham Controlled Multi-center Clinical Trial, Migraine Headache Treatment With Nerivio Migra Neurostimulation Device

This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio between treatment and control groups will be 1:1, stratified by center and use of preventive medications.

Study Overview

• Status: Terminated
• Conditions: Acute Migraine
• Intervention / Treatment: Device: Nerivio Migra neurostimulation; Device: Sham Nerivio Migra

Detailed Description

This is a prospective, randomized, double-blind, sham controlled multi-center clinical trial "Migraine Treatment with Nerivio Migra electro stimulation device". The study will enroll up to 248 patients diagnosed with migraine with and without aura, per the inclusion and exclusion criteria. These patients will be individually and randomly assigned to either treatment group or control group. For sham control, short electrical pulses of amplitude range similar to that of the treatment programs will be administered at very low frequency (0.1-0.5 Hz). The rationale underlying selection of sham control settings is that, on the one hand, pulses are perceivable and the user is able to manipulate their intensity similarly to the case of treatment programs, while, on the other hand, no clinically relevant treatment is delivered, based on existing knowledge of parameters range of electro stimulation treatmentsץ

Following successful screening, enrollment interview and signing of informed consent, participants will be provided with an active Nerivio Migra or identically looking sham device and trained to perform treatment and provide feedback via the smartphone application. Ratio between treatment and control groups will be 1:1.

Baseline information including mean frequency and severity of migraine attacks, occurrence of other headaches, presence of ICHD-3 diagnostic criteria for migraine with and without aura and use of preventive and rescue medications will be recorded.

Investigational devices will be programmed in active or sham mode with a 1:1 ratio, in order to achieve the desired ratio between active and control groups sizes.

Stage One. In stage one (roll-in phase) recruited participants will be reporting their migraine attacks per ICHD-3 diagnostic criteria, including presence of aura, using an electronic migraine diary installed on their smartphones. Duration of this phase is one month.

Participants that will report less than 2 or more than 8 migraine attacks during the roll-in period will be excluded from the treatment phase.

Stage Two. This will be the parallel arm treatment stage. Participants will be instructed to activate the device at onset of a qualifying migraine attack and manually adjust stimulation intensity to a level within the pre-defined range where it is well perceived but not painful. A qualifying migraine attack shall be preceded by at least 48 hours of freedom from headache. Patients will be requested to refrain from use of rescue medications prior to and during the first two hours after treatment with the device, and if they can not comply with this, record their use of rescue medications (migraine specific drugs or other medications or therapies that may be used to treat pain, from a pre-specified list) in the mobile application.

Via the smartphone application, each participant will be asked to rate his/her migraine pain level three times using Pain Grades Scale (0 - no pain, 1- mild pain, 2- moderate pain, 3 - severe pain): (1) upon starting the treatment, (2) two hours after start of treatment, (3) 48 hours after start of attack. At the start of each treatment, participants will be also asked to provide time elapsed from start of migraine attack to start of the treatment. Participants will be also asked to provide feedback regarding their use of medication (migraine specific drugs or other medications or therapies that may be used to treat pain, from a pre-specified list), presence of nausea, photophobia and phonophobia, and treatment perception. After providing feedback at two hours after start of treatment and in case of pain recurrence, participants will be allowed to re-treat the attack using Migra device.

Adverse events will be reported. Duration of study participation for each patient will be up to three months, determined by one month of the roll-in stage followed treatment of four qualifying attacks over the course of two months (whichever is achieved first).

Post study questionnaire will include patient global impression of change, blinding and usability assessments.

Stage Three. This part will include open label extended treatment. Following the completion of the study by all subjects and the return of all study devices, subjects will be offered a 2-month period of using active device, at no cost.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel
    • Hillel Yaffe Medical Center
  • Herzliya, Israel
    • Herzeliya medical center
  • Kefar Saba, Israel
    • Maccabi Healthcare neurology clinics
  • Nahariya, Israel
    • Western Galilee Medical Center
• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar - Georgetown University Hospital
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • Hartford, New York, United States, 06103
      • Hartford HealthCare Headache Center
    • New York, New York, United States, 11042
      • Northwell Health, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is 18-75 years old.
2. Patient meeting the ICHD-3 diagnostic criteria for migraine with and without aura.
3. Patients reporting 2-8 migraine attacks per month.
4. Patient must be able and willing to comply with the protocol.
5. Patient must be able and willing to provide written informed consent.
6. Male or non-pregnant / non-lactating female (NOTE: Females of child bearing potential must have a negative pregnancy test) and must be willing to use adequate contraceptive means during the study

Exclusion Criteria:

1. Has other significant pain problem that in the opinion of the investigator may confound the study assessments
2. Is currently implanted with an electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nerve stimulator).
3. Known uncontrolled epilepsy.
4. Use of Cannabis including medical use.
5. Has chronic migraine (more than 15 headache days per month).
6. Changed usage or dosage of migraine preventive medications in the last two months
7. Has undergone nerve block (occipital or other) in the head or neck within the last 2 weeks.
8. Is participating in any other clinical study. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nerivio Migra active; This arm will use the active device for acute treatment of migraine at the migraine symptoms onset. the device will be applied on the upper arm and controlled by a dedicated smartphone application.	Device: Nerivio Migra neurostimulation; transcutaneous electrical stimulation
Sham Comparator: Nerivio Migra placebo; This arm will use the sham device for acute treatment of migraine at the migraine symptoms onset. the device will be applied on the upper arm and controlled by a dedicated smartphone application.	Device: Sham Nerivio Migra; electrical stimulation- shame mode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Pain Relief 2 Hours Post Treatment	Percentage of participants reporting pain relief from pain (pain reduction from 3 or 2 to 1 or 0 or pain reduction from 1 to 0) 2 hours post treatment without rescue medications in at least 50% of treated attacks	2 hours post treatment

Collaborators and Investigators

• Sponsor: Theranica
• Investigators: Principal Investigator: Brian M Grosberg, MD, Hartford HealthCare Headache Center

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2017
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: TCH_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes