Migraine Treatment With Nerivio Migra Neurostimulation Device

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03076515
• Date of registration: 07/03/2017
• Prospective Registration: Yes
• Primary sponsor: Theranica
• Public title: Migraine Treatment With Nerivio Migra Neurostimulation Device
• Scientific title: A Prospective, Randomized, Double-blind, Sham Controlled Multi-center Clinical Trial, Migraine Headache Treatment With Nerivio Migra Neurostimulation Device
• Date of first enrolment: April 2, 2017
• Target sample size: 120
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03076515
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Israel, United States

Contacts

• Name: Brian M Grosberg, MD
• Affiliation: Hartford Healthcare Headache Center

Key inclusion & exclusion criteria

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. -



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Migraine

Intervention(s)

Device: Sham Nerivio Migra

Device: Nerivio Migra neurostimulation

Primary Outcome(s)

Percentage of Participants With Pain Relief 2 Hours Post Treatment [Time Frame: 2 hours post treatment]

Secondary ID(s)

TCH_002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03076515