MigraineNCT03185559
A Randomized, Double-blind Clinical Investigation to Evaluate the Use of the Relievion™ Device in Treating 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
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Jul 2017to 9 Jan 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
- History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD-III (International Classification of Headache Disorders) beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction).
- Capable of cooperating 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 (allodynia) that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 3 minutes of neurostimulation).
- Implanted metal or electrical devices in the head (not including dental implants).
Show all 18Show 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 of reproductive age not using efficient contraceptive method.
- History of cerebrovascular event.
- Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Double-blind, Parallel-group, Sham Controlled Single-center Pivotal Clinical Investigation to Evaluate the Clinical Safety and Performance of Self-administered Home-use Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation Device (Relievion™) in Treating Migraine.
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 |
| 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.
Pain Visual Analogue Scale (VAS) Change from basline to 1 hour
Mean change of pain score (measured on a visual analog scale) at 1 hour compared to baseline (if rescue therapy was not used)
Measured: 1 Hour
Secondary outcomes (7)
Pain VAS change from baseline to 30 minutes
Mean change of pain score (measured on a visual analog scale) at 30 minutes compared to baseline (if rescue therapy was not used).
Measured: 30 minutes
Pain VAS change from baseline to 2 hours
Mean change of pain score (measured on a visual analog scale) at 2 hours compared to baseline (if rescue therapy was not used).
Measured: 2 Hours
Pain VAS change from baseline to 24 hours
Mean change of pain score (measured on a visual analog scale) at 24 hours compared to baseline (if rescue therapy was not used).
Measured: 24 Hours
Pain VAS change from baseline to 48 hours
Mean change of pain score (measured on a visual analog scale) at 48 hours compared to baseline (if rescue therapy was not used).
Measured: 48 Hours
Rescue medication at 2 hours
Proportion of patients not having required rescue medication at 2 hours
Measured: 2 hours
Rescue medication within 24 hours
Proportion of patients not having required rescue medication within 24 hours
Measured: 24 hours
Rescue medication within 48 hours
Proportion of patients not having required rescue medication within 48 hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start23 Jul 2017
- Primary completion9 Jan 2018
- Study completion9 Jan 2018
Why it stopped: Investigator retierment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurolief Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Colin Klein, Dr, Principal investigator, Meir Medical Center, Kfar Saba, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185559
- Sponsor's protocol ID
- NRLF-0038-17-MMC-CTIL
- Status last verified
- Mar 2018
- First submitted
- 11 Jun 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Parallel-group, Sham Controlled Single-center Pivotal Clinical Investigation to Evaluate the Clinical Safety and Performance of Self-administered Home-use Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation Device (Relievion™) in Treating Migraine.
- ClinicalTrials.gov ID
- NCT03185559
- Acronym / sponsor ID
- NRLF-0038-17-MMC-CTIL
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator retierment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Neurolief Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2017 (actual)
- Primary completion
- 9 Jan 2018 (actual)
- Study completion
- 9 Jan 2018 (actual)
- First posted
- 14 Jun 2017 (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 |
| 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 (2 listed)
- History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD-III (International Classification of Headache Disorders) beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction).
- Capable of cooperating with the study protocol and to sign an informed consent.
Key exclusion criteria (18 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 (allodynia) that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 3 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 | Relievion device- Sham Stimulation |
Primary outcome
Pain Visual Analogue Scale (VAS) Change from basline to 1 hour
Time frame: 1 Hour
Mean change of pain score (measured on a visual analog scale) at 1 hour compared to baseline (if rescue therapy was not used)
7 secondary outcomes
Pain VAS change from baseline to 30 minutes
Time frame: 30 minutes
Pain VAS change from baseline to 2 hours
Time frame: 2 Hours
Pain VAS change from baseline to 24 hours
Time frame: 24 Hours
Pain VAS change from baseline to 48 hours
Time frame: 48 Hours
Rescue medication at 2 hours
Time frame: 2 hours
Rescue medication within 24 hours
Time frame: 24 hours
Rescue medication within 48 hours
Time frame: 48 hours
Results and safety
The study was stopped early (reason given: Investigator retierment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- 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.
Colin Klein, Dr principal investigator
Meir Medical Center, Kfar Saba, Israel
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 2 inclusion and 18 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 29 Mar 2018. 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 was stopped early (reason given: Investigator retierment). Results are not available in the source record.
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?
Pain Visual Analogue Scale (VAS) Change from basline to 1 hour (time frame: 1 Hour). 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 29 Mar 2018.