MigrainePhase 3NCT02725554
Study of Wireless Nerve Stimulation in the Treatment of Chronic Migraine
A Phase 3 study testing StimRelieve Halo System in people with Migraine, run by Curonix LLC.
Trial summary
The purpose of this study is to illustrate the safety and effectiveness of the StimRelieve Halo Nerve Stimulator System in the treatment of chronic migraine. The StimRelieve Halo System utilizes a minimally invasive procedure to implant a neurostimulator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- StimRelieve Halo System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 May 2025
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 years but less than 65 years of age at time of informed consent;
- Subject who developed chronic migraine before the age of 60 years old;
- Subjects have been diagnosed with chronic migraine according to the International Classification of Headache Disorders-3 (ICHD-3) (2013) criteria;
- No medication overuse and not attributed to another causative disorder;
- Subjects have chronic migraine for at least 6 months prior to enrollment;
- Are refractory to conventional pharmacological chronic migraine treatments as defined by the failure to respond, or the intolerance, to at least 3 prophylaxis therapies (of which one is topiramate if not contraindicated) as determined by the investigator;
Show all 11Show fewer
- Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
- Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;
- Based on the opinion of the Principal Investigator, subject is willing and able to operate the patient programmer, recharging equipment, and electronic diary equipment, and has the ability to undergo study assessments and provide accurate responses;
- Based on the opinion of the implanter, subject is a good surgical candidate for the implant procedure;
- Subject is male or non-pregnant female. If female of child-bearing potential, must have a negative pregnancy test at baseline visit, and if sexually active, must be using a medically acceptable method of contraception for the duration of their study participation; Subject is deemed to be neuropsychosocially appropriate for implantation therapies based of the assessment of a Clinical Psychologist, using face-to-face encounters and the psychological testing described in the measures.
Who cannot join
- Subject has undergone botulinum toxin (BOTOX) injections of the head and/or neck in the last 3 months;
- Subject is on prescribed opioid medication;
- Subject has a history of trigeminal autonomic cephalalgias;
- Subject has a history of other primary or secondary headache disorders;
- Subject has a history of trigeminal neuralgia;
- Subject has cranial postherpetic neuralgia (shingles);
Show all 15Show fewer
- Subject has an active systemic infection or is immunocompromised; Insulin-dependent diabetic who is not controlled through diet and/or medication (determined by the physician) or non-insulin dependent diabetic who is not well controlled through diet and/or medication;
- Bleeding complications or coagulopathy issues;
- A life expectancy of less than one year;
- Any active implanted device whether turned off or on;
- Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures.
- Based on the medical opinion of the Principal Investigator, Psychologist and/or Psychiatrist, the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study;
- Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study;
- Subject is currently involved in litigation regarding injury, or is receiving worker's compensation benefits;
- Subject is currently being treated with repetitive transcranial magnetic stimulation r(TMS) or electro convulsion therapy (ECT).
About this study
Official title: Prospective, Randomized, Controlled, Multi-Center Study of Wireless Nerve Stimulation in the Treatment of Chronic Migraine
The purpose of this study is to illustrate the safety and effectiveness of the StimRelieve Halo Nerve Stimulator System in the treatment of chronic migraine. The StimRelieve Halo System utilizes a minimally invasive procedure to implant a neurostimulator. This technology includes an octopolar electrode array stimulator with an embedded receiver. The energy source is a small, external, rechargeable transmitter, which is worn by the patient. The StimRelieve Halo System eliminates the implantable pulse generator, which has been the most common reason for reoperation or discomfort with existing devices.
For this study, all subjects will be randomized at enrollment into either a delayed or immediate continuation group. The immediate continuation group will immediately continue with the stimulation therapy after the 30-day trial period and will be monitored for a total of 12 months. The delayed activation group will have their device turned off after the 30-day trial period for the next 3-months. At the 3-month visit, both groups be evaluated and the delayed activation group will have their devices reactivated.
Read more
All subjects will immediately receive the permanent stimulator(s). The permanent stimulators can easily be removed if non-responders are identified. The wireless technology eliminates the need for externalized extensions, IPG's and thus reoperation. Additionally the outcome is highly dependent on placement of the stimulators. By eliminating the need for a staged trial, infection rates and incidence of pocket pain will decrease.
In this study, subjects will undergo a 30-day trial in order to demonstrate effectiveness. Immediate activation of all devices will be done in the post-op period based on sensory response and subject comfort. Subjects will be seen at 14-days post-implant to assess patient compliance with the device, assess clinical response and to adjust programming parameters if not responding. Subjects will be seen at 1 month post-implant and headache diaries and questionnaires will be reviewed. Subjects not responding to the therapy by at least a 30% reduction in headache days will be deemed non-responders and will be withdrawn from the study and can choose to have the device removed. After the trial period, all responders will follow their random assignment determined at enrollment (delayed or immediate continuation). All subjects will be monitored for a total of 13 months. Adverse events will be monitored throughout the study.
- Conditions
- Migraine
- Being tested
- StimRelieve Halo System
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimRelieve Halo SystemDevice
The StimRelieve Halo System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic migraine as defined by the Third edition of the International Classification of headache disorders (ICDH-3). The system provides treatment by delivering small controlled electrical pulses to the occipital and supraorbital nerves, as it has been shown that for chronic migraine headaches the response to combined systems appears to be substantially better than occipital nerves stimulation alone.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Continuation Group | Active comparator | All Subjects will be implanted with the StimRelieve HALO System. Subjects randomized to the delayed continuation group will have their systems deactivated until their 3 months follow-up visit. After this visit the stimulation will be reactivated. Receives: Device: StimRelieve Halo System |
| Continued Stim Group | Experimental | All Subjects will be implanted with the StimRelieve HALO System. Subjects randomized to the continued stim group will continue with active stimulation and monitored at defined intervals for data collection and device reprogramming, if needed. Receives: Device: StimRelieve Halo System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Days
The primary effectiveness endpoint is defined as a ≥ 30% reduction in headache days per month at 3 months post-trial with no increase in medication as compared to baseline.
Measured: 3 Months
Adverse Events
The primary safety endpoint is the incidence and severity of adverse events through 3 months post-trial.
Measured: 12 Months
Secondary outcomes (4)
Migraine Days
Change in number of migraine days per month from baseline to 3 months post-trial
Measured: 3 Months
Headache Days
Change in number of headache days per month from baseline to 3 months post-trial
Measured: 3 Months
Headache Impact Test (HIT) Score
Change from baseline in total HIT-6 score to 3 months post-trial
Measured: 3 Months
Pain Medication
Change from baseline in frequency of acute headache pain medication intake (all categories) at 3 months post-trial
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study start1 May 2025
- Primary completion1 May 2025
- Study completion1 May 2025
Why it stopped: This study was never initiated
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curonix LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725554
- Sponsor's protocol ID
- 30-00070
- Status last verified
- May 2025
- First submitted
- 29 Mar 2016
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Within 6 months of end of study, data will be published. All study subject data will be anonymous.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled, Multi-Center Study of Wireless Nerve Stimulation in the Treatment of Chronic Migraine
- ClinicalTrials.gov ID
- NCT02725554
- Acronym / sponsor ID
- 30-00070
- Conditions
- Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Curonix LLCIndustry (pharma, biotech, devices)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 1 Apr 2016 (estimated)
- 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.
The purpose of this study is to illustrate the safety and effectiveness of the StimRelieve Halo Nerve Stimulator System in the treatment of chronic migraine. The StimRelieve Halo System utilizes a minimally invasive procedure to implant a neurostimulator. This technology includes an octopolar electrode array stimulator with an embedded receiver. The energy source is a small, external, rechargeable transmitter, which is worn by the patient. The StimRelieve Halo System eliminates the implantable pulse generator, which has been the most common reason for reoperation or discomfort with existing devices.
For this study, all subjects will be randomized at enrollment into either a delayed or immediate continuation group. The immediate continuation group will immediately continue with the stimulation therapy after the 30-day trial period and will be monitored for a total of 12 months. The delayed activation group will have their device turned off after the 30-day trial period for the next 3-months. At the 3-month visit, both groups be evaluated and the delayed activation group will have their devices reactivated.
All subjects will immediately receive the permanent stimulator(s). The permanent stimulators can easily be removed if non-responders are identified. The wireless technology eliminates the need for externalized extensions, IPG's and thus reoperation. Additionally the outcome is highly dependent on placement of the stimulators. By eliminating the need for a staged trial, infection rates and incidence of pocket pain will decrease.
In this study, subjects will undergo a 30-day trial in order to demonstrate effectiveness. Immediate activation of all devices will be done in the post-op period based on sensory response and subject comfort. Subjects will be seen at 14-days post-implant to assess patient compliance with the device, assess clinical response and to adjust programming parameters if not responding. Subjects will be seen at 1 month post-implant and headache diaries and questionnaires will be reviewed. Subjects not responding to the therapy by at least a 30% reduction in headache days will be deemed non-responders and will be withdrawn from the study and can choose to have the device removed. After the trial period, all responders will follow their random assignment determined at enrollment (delayed or immediate continuation). All subjects will be monitored for a total of 13 months. Adverse events will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Continuation Group | Active comparator | Device: StimRelieve Halo SystemAll Subjects will be implanted with the StimRelieve HALO System. Subjects randomized to the delayed continuation group will have their systems deactivated until their 3 months follow-up visit. After this visit the stimulation will be reactivated. |
| Continued Stim Group | Experimental | Device: StimRelieve Halo SystemAll Subjects will be implanted with the StimRelieve HALO System. Subjects randomized to the continued stim group will continue with active stimulation and monitored at defined intervals for data collection and device reprogramming, if needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is ≥ 18 years but less than 65 years of age at time of informed consent;
- Subject who developed chronic migraine before the age of 60 years old;
- Subjects have been diagnosed with chronic migraine according to the International Classification of Headache Disorders-3 (ICHD-3) (2013) criteria;
- No medication overuse and not attributed to another causative disorder;
- Subjects have chronic migraine for at least 6 months prior to enrollment;
Key exclusion criteria (15 listed)
- Subject has undergone botulinum toxin (BOTOX) injections of the head and/or neck in the last 3 months;
- Subject is on prescribed opioid medication;
- Subject has a history of trigeminal autonomic cephalalgias;
- Subject has a history of other primary or secondary headache disorders;
- Subject has a history of trigeminal neuralgia;
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 |
|---|---|---|
| StimRelieve Halo SystemThe StimRelieve Halo System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic migraine as defined by the Third edition of the International Classification of headache disorders (ICDH-3). The system provides treatment by delivering small controlled electrical pulses to the occipital and supraorbital nerves, as it has been shown that for chronic migraine headaches the response to combined systems appears to be substantially better than occipital nerves stimulation alone. | Device | Continued Stim Group, Delayed Continuation Group |
Primary outcome
Headache Days
Time frame: 3 Months
The primary effectiveness endpoint is defined as a ≥ 30% reduction in headache days per month at 3 months post-trial with no increase in medication as compared to baseline.
Adverse Events
Time frame: 12 Months
The primary safety endpoint is the incidence and severity of adverse events through 3 months post-trial.
4 secondary outcomes
Migraine Days
Time frame: 3 Months
Headache Days
Time frame: 3 Months
Headache Impact Test (HIT) Score
Time frame: 3 Months
Pain Medication
Time frame: 3 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: Yes. Within 6 months of end of study, data will be published. All study subject data will be anonymous.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing StimRelieve Halo System in people with Migraine, run by Curonix LLC.
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 11 inclusion and 15 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: withdrawn, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Headache Days (time frame: 3 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 8 May 2025.