Acute MigraineNCT03076515
Migraine Treatment With Nerivio Migra Neurostimulation Device
A study testing Nerivio Migra neurostimulation in people with Acute Migraine, run by Theranica at 8 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Migraine
- What is being tested?
- Nerivio Migra neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 2 Apr 2017to 1 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 18-75 years old.
- Patient meeting the ICHD-3 diagnostic criteria for migraine with and without aura.
- Patients reporting 2-8 migraine attacks per month.
- Patient must be able and willing to comply with the protocol.
- Patient must be able and willing to provide written informed consent.
- 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
Who cannot join
- Has other significant pain problem that in the opinion of the investigator may confound the study assessments
- 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).
- Known uncontrolled epilepsy.
- Use of Cannabis including medical use.
- Has chronic migraine (more than 15 headache days per month).
- Changed usage or dosage of migraine preventive medications in the last two months
- Has undergone nerve block (occipital or other) in the head or neck within the last 2 weeks.
- Is participating in any other clinical study. -
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States4 sites
Albany Medical College
Albany, New York, 12208
Hartford Healthcare Headache Center
Hartford, New York, 06103
Northwell Health, Inc
New York, New York, 11042
MedStar - Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Israel4 sites
Hillel Yaffe Medical Center
Hadera
Herzeliya medical Center
Herzliya
Maccabi Healthcare neurology clinics
Kfar Saba
Western Galilee Medical Center
Nahariya
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Migraine
- Being tested
- Nerivio Migra neurostimulation, Sham Nerivio Migra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerivio Migra neurostimulationDevice
transcutaneous electrical stimulation
Sham Nerivio MigraDevice
electrical stimulation- shame mode
| Study group | Role | What they receive |
|---|---|---|
| Nerivio Migra active | Active comparator | 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. Receives: Device: Nerivio Migra neurostimulation |
| Nerivio Migra placebo | Sham comparator | 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. Receives: Device: Sham Nerivio Migra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start2 Apr 2017
- Primary completion31 Jan 2018
- Study completion1 Apr 2018
Why it stopped: Study was prematurely stop based on DMC recommendation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian M Grosberg, MD, Principal investigator, Hartford Healthcare Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076515
- Sponsor's protocol ID
- TCH_002
- Status last verified
- Oct 2020
- First submitted
- 7 Mar 2017
- Last updated
- 17 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Sham Controlled Multi-center Clinical Trial, Migraine Headache Treatment With Nerivio Migra Neurostimulation Device
- ClinicalTrials.gov ID
- NCT03076515
- Acronym / sponsor ID
- TCH_002
- Conditions
- Acute Migraine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was prematurely stop based on DMC recommendation
- Enrolment
- 120 participants (actual)
- Lead sponsor
- TheranicaIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Posted 20 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerivio Migra active | Active comparator | Device: Nerivio Migra neurostimulationThis 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. |
| Nerivio Migra placebo | Sham comparator | Device: Sham Nerivio MigraThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is 18-75 years old.
- Patient meeting the ICHD-3 diagnostic criteria for migraine with and without aura.
- Patients reporting 2-8 migraine attacks per month.
- Patient must be able and willing to comply with the protocol.
- Patient must be able and willing to provide written informed consent.
Key exclusion criteria (8 listed)
- Has other significant pain problem that in the opinion of the investigator may confound the study assessments
- 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).
- Known uncontrolled epilepsy.
- Use of Cannabis including medical use.
- Has chronic migraine (more than 15 headache days per month).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerivio Migra neurostimulationtranscutaneous electrical stimulation | Device | Nerivio Migra active |
| Sham Nerivio Migraelectrical stimulation- shame mode | Device | Nerivio Migra placebo |
Primary outcome
Percentage of Participants With Pain Relief 2 Hours Post Treatment
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian M Grosberg, MD principal investigator
Hartford Healthcare Headache Center
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerivio Migra neurostimulation in people with Acute Migraine, run by Theranica at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Pain Relief 2 Hours Post Treatment (time frame: 2 hours post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.