MigrainePSWTNCT03166046
Migraine Prevention Using ActiPatch
A study testing Pulsed Shortwave Therapy in people with Migraine, run by BioElectronics Corporation at 1 site in United States.
Trial summary
Chronic pain is now widely understood to be due to central sensitization, which leads to exaggerated pain perception. Migraine is no exception, since it is well known that sensitization of the trigeminovascular pain pathway can occur during a migraine attach. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Migraine
- What is being tested?
- Pulsed Shortwave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 30 Apr 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the trial.
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
- Male or female ages 18 or above with migraine headache
- 3 or greater occurrences of migraine per month
- no prior use of neuromodulation for migraine headache
Who cannot join
- Female participant who is pregnant
- prior use of neuromodulation for migraine headache
- Laminectomy, laminotomy or discectomy within 12 months of enrollment.
- Active psychiatric disorders will be excluded (e.g. use of antipsychotic medication, bipolar disorder, schizophrenia).
- Patients diagnosed with history of significant mood disorder will be excluded (e.g., depression or anxiety with adequate control would be acceptable).
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Migraine Prevention Using Pulsed Shortwave Therapy
Chronic pain is now widely understood to be due to central sensitization, which leads to exaggerated pain perception. Migraine is no exception, since it is well known that sensitization of the trigeminovascular pain pathway can occur during a migraine attach. There is early evidence that ActiPatch can help mitigate this sensitization, so this study is being conducted to determine the efficacy of ActiPatch in preventing chronic, episodic migraines.
Read the detailed description
Migraine is a common neurological disorder characterized by episodes of unilateral or bilateral headache lasting for hours to days, which may be accompanied by photophobia, phonophobia, nausea and vomiting. Pharmacological management is the first treatment option for subjects with migraine. However, some patients do not tolerate acute and/or prophylactic medicine due to side effects or contraindications due to comorbidity of other diseases or due to a wish to avoid medication for other reasons. The risk of medication overuse due to frequent migraine attacks represents a major health hazard with direct and indirect cost concerns. The prevalence of medication overuse headache is 1 -2% in the general population, that is, about half the population suffering chronic headache (15 headache days or more per month) have medication overuse headache.It is well-known that a primary brain dysfunction leads to episodic activation and sensitization of the trigeminovascular pain pathway during attacks. However, a functional and anatomic relationship exists between peripheral afferent nerves supplying the head and neck and the brainstem, subcortical and higher order brain processing centers. There is some evidence that interventions targeting peripheral nerves are able to modulate neuronal circuits involved in pain control and that they could be useful in some selected patients with migraine.
Supraorbital neurostimulation (tSNS) of the upper branches of the trigeminal nerves was found superior to sham stimulation for episodic migraine prevention in a previous randomized trial in a large cohort of patients with migraine. In this study the pulsed shortwave device will be incorporated in a wrap which will enable easy placement of the device in the desired located which will be over the supratrochlear and supraorbital branches of the ophthalmic nerve.
- Conditions
- Migraine
- Being tested
- Pulsed Shortwave Therapy, Placebo Pulsed Shortwave therapy
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Shortwave TherapyDevice
Also called ActiPatch
Stimulation of the supratrochlear and supraorbital branches of the ophthalmic nerve.
Placebo Pulsed Shortwave therapyDevice
Also called Placebo ActiPatch
Placebo Stimulation of the supratrochlear and supraorbital branches of the ophthalmic nerve.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Active comparator | Subjects will use the active pulsed shortwave therapy device (ActiPatch) as a prophylactic treatment for episodic migraine Receives: Device: Pulsed Shortwave Therapy |
| Control Group | Placebo comparator | Subjects will use the placebo pulsed shortwave therapy device (Placebo ActiPatch) as a prophylactic treatment for episodic migraine Receives: Device: Placebo Pulsed Shortwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine frequency
frequency of migraine attacks
Measured: 4 weeks
Migraine duration
Duration of migraine attacks
Measured: 4 weeks
Secondary outcomes (2)
Migraine intensity measured with Visual Analogue Pain Score
Migraine intensity measured with visual analogue pain score (VAS scores)
Measured: 4 weeks
Headache disability measured with Headache Impact Test
Headache impact test (HIT-6)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Jun 2017
- Primary completion1 Apr 2018
- Study completion30 Apr 2018
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
- Model description
- Randomized, double blind, placebo controlled trial using an active pulsed shortwave therapy device or placebo pulsed shortwave therapy device
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioElectronics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sree Koneru, Ph.D., Study director, BioElectronics CorporationBarry Eppley, MD, Principal investigator, Eppley GroupIan Rawe, Ph.D., Study chair, BioElectronics Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166046
- Sponsor's protocol ID
- SAIRB-17-0021
- Acronym
- PSWT
- Status last verified
- Aug 2018
- First submitted
- 22 May 2017
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine Prevention Using Pulsed Shortwave Therapy
- ClinicalTrials.gov ID
- NCT03166046
- Acronym / sponsor ID
- PSWT / SAIRB-17-0021
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- BioElectronics CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 24 May 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.
Chronic pain is now widely understood to be due to central sensitization, which leads to exaggerated pain perception. Migraine is no exception, since it is well known that sensitization of the trigeminovascular pain pathway can occur during a migraine attach. There is early evidence that ActiPatch can help mitigate this sensitization, so this study is being conducted to determine the efficacy of ActiPatch in preventing chronic, episodic migraines.
Detailed description
Migraine is a common neurological disorder characterized by episodes of unilateral or bilateral headache lasting for hours to days, which may be accompanied by photophobia, phonophobia, nausea and vomiting. Pharmacological management is the first treatment option for subjects with migraine. However, some patients do not tolerate acute and/or prophylactic medicine due to side effects or contraindications due to comorbidity of other diseases or due to a wish to avoid medication for other reasons. The risk of medication overuse due to frequent migraine attacks represents a major health hazard with direct and indirect cost concerns. The prevalence of medication overuse headache is 1 -2% in the general population, that is, about half the population suffering chronic headache (15 headache days or more per month) have medication overuse headache.It is well-known that a primary brain dysfunction leads to episodic activation and sensitization of the trigeminovascular pain pathway during attacks. However, a functional and anatomic relationship exists between peripheral afferent nerves supplying the head and neck and the brainstem, subcortical and higher order brain processing centers. There is some evidence that interventions targeting peripheral nerves are able to modulate neuronal circuits involved in pain control and that they could be useful in some selected patients with migraine.
Supraorbital neurostimulation (tSNS) of the upper branches of the trigeminal nerves was found superior to sham stimulation for episodic migraine prevention in a previous randomized trial in a large cohort of patients with migraine. In this study the pulsed shortwave device will be incorporated in a wrap which will enable easy placement of the device in the desired located which will be over the supratrochlear and supraorbital branches of the ophthalmic nerve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blind, placebo controlled trial using an active pulsed shortwave therapy device or placebo pulsed shortwave therapy device
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Device: Pulsed Shortwave TherapySubjects will use the active pulsed shortwave therapy device (ActiPatch) as a prophylactic treatment for episodic migraine |
| Control Group | Placebo comparator | Device: Placebo Pulsed Shortwave therapySubjects will use the placebo pulsed shortwave therapy device (Placebo ActiPatch) as a prophylactic treatment for episodic migraine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is willing and able to give informed consent for participation in the trial.
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
- Male or female ages 18 or above with migraine headache
- 3 or greater occurrences of migraine per month
- no prior use of neuromodulation for migraine headache
Key exclusion criteria (8 listed)
- Female participant who is pregnant
- prior use of neuromodulation for migraine headache
- Laminectomy, laminotomy or discectomy within 12 months of enrollment.
- Active psychiatric disorders will be excluded (e.g. use of antipsychotic medication, bipolar disorder, schizophrenia).
- Patients diagnosed with history of significant mood disorder will be excluded (e.g., depression or anxiety with adequate control would be acceptable).
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 |
|---|---|---|
| Pulsed Shortwave TherapyAlso: ActiPatchStimulation of the supratrochlear and supraorbital branches of the ophthalmic nerve. | Device | Study Group |
| Placebo Pulsed Shortwave therapyAlso: Placebo ActiPatchPlacebo Stimulation of the supratrochlear and supraorbital branches of the ophthalmic nerve. | Device | Control Group |
Primary outcome
Migraine frequency
Time frame: 4 weeks
frequency of migraine attacks
Migraine duration
Time frame: 4 weeks
Duration of migraine attacks
2 secondary outcomes
Migraine intensity measured with Visual Analogue Pain Score
Time frame: 4 weeks
Headache disability measured with Headache Impact Test
Time frame: 4 weeks
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 2 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Migraine
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Active, not recruitingObservational study
Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
Migraine
Active, not recruitingObservational study
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Migraine
RecruitingObservational study
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
Migraine
RecruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
Post Traumatic Headache
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.
Sree Koneru, Ph.D. study director
BioElectronics Corporation
Barry Eppley, MD principal investigator
Eppley Group
Ian Rawe, Ph.D. study chair
BioElectronics Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Shortwave Therapy in people with Migraine, run by BioElectronics Corporation at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 2 Aug 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 United States. 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?
Migraine frequency (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 2 Aug 2018.