Episodic MigraineNCT04166045
Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain
A study testing Verum Treatment Location in people with Episodic Migraine, run by Theranova, L.L.C. at 1 site in United States.
Trial summary
Clinical study to determine the responder rate of the TheraNova Migraine Treatment System to that of a sham control treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Episodic Migraine
- What is being tested?
- Verum Treatment Location
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2020to 29 Apr 2021
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-100 years, inclusive
- Diagnosis of episodic migraine with and without aura per International Headache Society diagnostic criteria
- 4-14 migraine days per month
- Ability to provide informed consent
- Demonstrates no contraindication to the use of electrical nerve stimulation
- Capable and willing to follow all study-related procedures
Who cannot join
- Currently pregnant or breastfeeding, pregnant within the past 6 months or intends to become pregnant during the enrollment period
- Diagnosis of chronic migraine or other forms of primary or secondary headache disorders, including medication overuse headache per International Headache Society diagnostic criteria
- Any medical condition that would, in the opinion of the investigator, make the subject ineligible
- Has received botulinum toxin injections within the past 3 months
- Is currently implanted with an electrical and/or neurostimulator devic, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, sacral stimulator, bone growth stimulator, or cochlear implant
- Use of investigational drug/device therapy within the past 4 weeks
- Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination (including bleeding disorders, anticoagulant medications and peripheral neuropathy)
- No changes in preventive medications (or other medications determined to potentially interfere with the study) in the previous 30 days and no intent to change it during the study
Trial locations and contacts
1 site in 1 country.
About this study
Clinical study to determine the responder rate of the TheraNova Migraine Treatment System to that of a sham control treatment.
- Conditions
- Episodic Migraine
- Being tested
- Sham Treatment Location, Verum Treatment Location
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham Treatment LocationDevice
The device applies transcutaneous electrical nerve stimulation to the bicep
Verum Treatment LocationDevice
The device applies transcutaneous electrical nerve stimulation to the hand
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Treatment at the bicep location Receives: Device: Sham Treatment Location |
| Verum | Active comparator | Treatment at the hand location Receives: Device: Verum Treatment Location |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in pain score
We will also assess the change in migraine pain before versus after treatment with the 100-mm Visual Analogue Scale (VAS), which is a continuum scale that patients can quantify their pain from none (0 mm) to extreme (100 mm) for both treatment sites. The mean score for each patient cohort will be calculated. We will also perform a sub analysis on women versus men.
Measured: 4 months
Percent of subjects who are responders
For each subject treatment effectiveness will be assessed by both achieving pain relief (if the pain decreases from a 4-point visual rating scale (VRS) of 'severe' or 'moderate' at pre-treatment to 'mild' or 'none' at 120-min post-treatment) or pain-free ('none') status. The percent of subjects that experience a significant reduction in pain relief score (VRS) will be calculated for the verum and sham treatment sites.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start12 Jun 2020
- Primary completion29 Apr 2021
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episodic 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranova, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166045
- Sponsor's protocol ID
- CRD-01-1282-01
- Status last verified
- Jul 2021
- First submitted
- 13 Nov 2019
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain
- ClinicalTrials.gov ID
- NCT04166045
- Acronym / sponsor ID
- CRD-01-1282-01
- Conditions
- Episodic Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Theranova, L.L.C.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 18 Nov 2019 (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.
Clinical study to determine the responder rate of the TheraNova Migraine Treatment System to that of a sham control treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Device: Sham Treatment LocationTreatment at the bicep location |
| Verum | Active comparator | Device: Verum Treatment LocationTreatment at the hand location |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-100 years, inclusive
- Diagnosis of episodic migraine with and without aura per International Headache Society diagnostic criteria
- 4-14 migraine days per month
- Ability to provide informed consent
- Demonstrates no contraindication to the use of electrical nerve stimulation
Key exclusion criteria (8 listed)
- Currently pregnant or breastfeeding, pregnant within the past 6 months or intends to become pregnant during the enrollment period
- Diagnosis of chronic migraine or other forms of primary or secondary headache disorders, including medication overuse headache per International Headache Society diagnostic criteria
- Any medical condition that would, in the opinion of the investigator, make the subject ineligible
- Has received botulinum toxin injections within the past 3 months
- Is currently implanted with an electrical and/or neurostimulator devic, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, sacral stimulator, bone growth stimulator, or cochlear implant
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 |
|---|---|---|
| Sham Treatment LocationThe device applies transcutaneous electrical nerve stimulation to the bicep | Device | Sham |
| Verum Treatment LocationThe device applies transcutaneous electrical nerve stimulation to the hand | Device | Verum |
Primary outcome
Mean change in pain score
Time frame: 4 months
We will also assess the change in migraine pain before versus after treatment with the 100-mm Visual Analogue Scale (VAS), which is a continuum scale that patients can quantify their pain from none (0 mm) to extreme (100 mm) for both treatment sites. The mean score for each patient cohort will be calculated. We will also perform a sub analysis on women versus men.
Percent of subjects who are responders
Time frame: 4 months
For each subject treatment effectiveness will be assessed by both achieving pain relief (if the pain decreases from a 4-point visual rating scale (VRS) of 'severe' or 'moderate' at pre-treatment to 'mild' or 'none' at 120-min post-treatment) or pain-free ('none') status. The percent of subjects that experience a significant reduction in pain relief score (VRS) will be calculated for the verum and sham treatment sites.
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 26 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum Treatment Location in people with Episodic Migraine, run by Theranova, L.L.C. 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 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: finished, as of the sponsor's last update on 26 Jul 2021. 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?
Mean change in pain score (time frame: 4 months). 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 26 Jul 2021.