MigraineNCT03398668
Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
A study testing Relievion device- Treatment stimulation in people with Migraine, run by Neurolief Ltd. at 1 site in Israel.
Trial summary
This study will evaluate the clinical performance and safety of a self administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relievion™). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Relievion device- Treatment stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Feb 2018to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females Ages of 18 to 65 years old.
- History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD (International Classification of Headache Disorders)-III beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction).
- Capable to corporate with the study protocol and to sign an informed consent.
Who cannot join
- Patients having received Botox treatment in the head region in the prior 4 months.
- Patients having received supraorbital or occipital nerve blocks in the prior 4 months.
- History of Medication Overuse Headache.
- Patients using opioid medication.
- Allodynia: intolerance to supraorbital and/or occipital neurostimulation that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 10 minutes of neurostimulation).
- Implanted metal or electrical devices in the head (not including dental implants).
Show all 20Show fewer
- Patient having had a previous experience with the Relievion™ device.
- Patients who have concomitant epilepsy.
- History of neurosurgical interventions.
- Patients with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
- History of drug abuse or alcoholism.
- Participation in current clinical study or participated in a clinical study within 3 months prior to this study.
- Skin lesion or inflammation at the region of the stimulating electrodes.
- Personality or somatoform disorder.
- Pregnancy or Lactation.
- Women with child bearing potential without medically acceptable method of contraception.
- History of cerebrovascular event.
- Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study).
- Patients using Cannabis
- Patients with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the clinical performance and safety of a self administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relievion™).
- Conditions
- Migraine
- Being tested
- Relievion device- Treatment stimulation, Relievion Device- Sham stimulation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relievion device- Treatment stimulationDevice
Also called Neurolief device
1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation
Relievion Device- Sham stimulationDevice
Also called Sham Neurolief device
1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| Relievion device- Treatment stimulation | Active comparator | Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation Receives: Device: Relievion device- Treatment stimulation |
| Sham Comparator: Relievion device- Sham Stimulation | Sham comparator | Relievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation Receives: Device: Relievion Device- Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of pain score (measured on a visual analog scale=VAS) at 1 hour compared to baseline
visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable pain
Measured: 1 hour
Secondary outcomes (6)
Mean change of pain score (measured by VAS) at 2 hours compared to baseline (if rescue therapy was not used).
visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable painbaseline (if rescue therapy was not used).
Measured: 2 hours
Mean change of pain score (measured by VAS) at 24 hours compared to baseline (if rescue therapy was not used).
Mean change of pain score (measured by VAS) at 24 hours compared to baseline (if rescue therapy was not used).
Measured: 24 hours
Proportion of patients not having required rescue medication within 24 hours
Proportion of patients not having required rescue medication within 24 hours
Measured: 24 hours
Proportion of patients not having required rescue medication at 2 hours compared to baseline.
Proportion of patients not having required rescue medication at 2 hours
Measured: 2 hours
Proportion of patients pain free at 1,2 and 24 hours from baseline (if rescue therapy was not used).
Proportion of patients pain free at 1,2 and 24 hours from baseline (if rescue therapy was not used).
Measured: 1, 2, 24 hours
Proportion of "responders" ("responder" is defined as decrease of at least 50% in VAS pain score from baseline) at 1,2 and 24 hours from baseline (if rescue therapy was not used).
visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable pain
Measured: 1, 2, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start22 Feb 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurolief Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Dr. Oved, Dr., Principal investigator, Laniado Medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398668
- Sponsor's protocol ID
- SP301
- Status last verified
- Mar 2019
- First submitted
- 8 Jan 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Daniel O, Tepper SJ, Deutsch L, Sharon R. External Concurrent Occipital and Trigeminal Neurostimulation Relieves Migraine Headache: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial. Pain Ther. 2022 Sep;11(3):907-922. doi: 10.1007/s40122-022-00394-w. Epub 2022 Jun 4.
PubMed 35661128
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
- ClinicalTrials.gov ID
- NCT03398668
- Acronym / sponsor ID
- SP301
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Neurolief Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the clinical performance and safety of a self administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relievion™).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relievion device- Treatment stimulation | Active comparator | Device: Relievion device- Treatment stimulationRelievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation |
| Sham Comparator: Relievion device- Sham Stimulation | Sham comparator | Device: Relievion Device- Sham stimulationRelievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females Ages of 18 to 65 years old.
- History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD (International Classification of Headache Disorders)-III beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction).
- Capable to corporate with the study protocol and to sign an informed consent.
Key exclusion criteria (20 listed)
- Patients having received Botox treatment in the head region in the prior 4 months.
- Patients having received supraorbital or occipital nerve blocks in the prior 4 months.
- History of Medication Overuse Headache.
- Patients using opioid medication.
- Allodynia: intolerance to supraorbital and/or occipital neurostimulation that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 10 minutes of neurostimulation).
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 |
|---|---|---|
| Relievion device- Treatment stimulationAlso: Neurolief device1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation | Device | Relievion device- Treatment stimulation |
| Relievion Device- Sham stimulationAlso: Sham Neurolief device1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation | Device | Sham Comparator: Relievion device- Sham Stimulation |
Primary outcome
Mean change of pain score (measured on a visual analog scale=VAS) at 1 hour compared to baseline
Time frame: 1 hour
visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable pain
6 secondary outcomes
Mean change of pain score (measured by VAS) at 2 hours compared to baseline (if rescue therapy was not used).
Time frame: 2 hours
Mean change of pain score (measured by VAS) at 24 hours compared to baseline (if rescue therapy was not used).
Time frame: 24 hours
Proportion of patients not having required rescue medication within 24 hours
Time frame: 24 hours
Proportion of patients not having required rescue medication at 2 hours compared to baseline.
Time frame: 2 hours
Proportion of patients pain free at 1,2 and 24 hours from baseline (if rescue therapy was not used).
Time frame: 1, 2, 24 hours
Proportion of "responders" ("responder" is defined as decrease of at least 50% in VAS pain score from baseline) at 1,2 and 24 hours from baseline (if rescue therapy was not used).
Time frame: 1, 2, 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Derived from this study: PubMed 35661128Daniel O, Tepper SJ, Deutsch L, Sharon R. External Concurrent Occipital and Trigeminal Neurostimulation Relieves Migraine Headache: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial. Pain Ther. 2022 Sep;11(3):907-922. doi: 10.1007/s40122-022-00394-w. Epub 2022 Jun 4.
- 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.
Daniel Dr. Oved, Dr. principal investigator
Laniado Medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relievion device- Treatment stimulation in people with Migraine, run by Neurolief Ltd. at 1 site in Israel.
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 3 inclusion and 20 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: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change of pain score (measured on a visual analog scale=VAS) at 1 hour compared to baseline (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03398668, which also lists 1 linked publication.
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 13 Mar 2019.