MigraineNCT07772427
Neuromodulation During the Prodrome to Prevent Disabling Migraine Attacks in Youth
A study testing Active Remote Electrical Neuromodulation in people with Migraine and Migraine Headache, run by University of Calgary at 1 site in Canada.
Trial summary
Background \& Rationale: One in ten Canadian youth have migraine, a disabling neurological disease that is more common in females and characterized by moderate-severe disabling headaches. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Migraine, Migraine Headache
- What is being tested?
- Active Remote Electrical Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- youth aged 8-<18 years with a diagnosis of migraine using gold standard International Classification of Headache Disorders criteria
- self-reporting 2-14 headache days/month in the last 3 months
- reporting prodromal symptoms that predict a headache within six hours >75% of the time.
- To proceed past the 60-day screening period to randomization, participants will need to report 3-28 qualifying prodrome events with >75% of these events followed by a headache within 6 hours.
Who cannot join
- the inability to read or understand English
- a diagnosis of psychosis, schizophrenia, or moderate-severe autism, moderate-severe developmental delay or moderate-severe intellectual disability
- implanted electrical device
- uncontrolled epilepsy (i.e., >2 seizures in the past year)
- abnormal skin on both upper arms
- arm circumference <20 cm
- severe cardiac or cerebrovascular disease
- prior participation in the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Serena L Orr, MD, MSc, FRCPC, (403) 955-7728, serena.orr@albertahealthservices.ca
Jonathan WP Kuziek, MSc, (780)446-1851, jonathan.kuziek@ucalgary.ca
About this study
Official title: Neuromodulation During the Prodrome to Prevent Disabling Migraine Attacks in Children and Adolescents - a Pilot Randomized Controlled Trial
Background \& Rationale:
One in ten Canadian youth have migraine, a disabling neurological disease that is more common in females and characterized by moderate-severe disabling headaches. Migraine attacks occur in a cycle that begins with a prodromal phase, followed by aura, a pain phase (headache), and finally a postdrome phase when the pain is resolved but other symptoms persist. The prodrome is recognized by ~90% of all youth with migraine, occurs up to 24 hours before headache onset, and consists of a variety of symptoms including, but not limited to, food cravings, fatigue, yawning, mood changes, and sensory hypersensitivity (e.g., light sensitivity). Prodromal symptoms are disabling and frequently graded as moderate to severe. All acute migraine treatments for youth have been studied for use in the pain phase, with the greatest treatment success early in this phase. Unfortunately, only ~1/3 of youth achieve pain freedom within two hours. Recently, a groundbreaking trial found that treatment during the prodrome could prevent the pain phase, although prodromal treatment does not exist for youth.
Read more
In considering the most innovative, safe, and patient-centered prodromal intervention, remote electrical neuromodulation (REN) is the obvious choice. The investigator's engagement with 175 youth with migraine and their caregivers shows that REN is preferred when pill-based interventions are ineffective or impractical. REN has none of the limitations of pill-based prodromal treatment. The REN device is wearable, battery-operated, worn on the upper arm, and controlled wirelessly by a smartphone application. REN electrically stimulates sensory nerves in the arm below their perceived pain thresholds, but above their depolarization thresholds, to induce a conditioned pain modulation response in the brain to modulate incoming migraine pain signals.
Clinical trial and observational studies in youth with migraine have shown REN's safety and efficacy for home-based treatment during the pain phase and led the FDA to clear its use in youth >8 years. In the adolescent trial, 71% of participants had pain relief at two hours, there were no serious adverse events (AE), and only one device-related AE (transient arm pain) occurred. Also, emerging data show that adults with migraine in the prodrome phase display pain facilitation due to a deficit in pain modulation. Thus, REN's mechanism of action is likely to be more effective during the prodrome vs. the pain phase as it can "turn on" deficient pain modulatory areas earlier when they are most impaired.
Research Question \& Objectives:
The investigators aim to determine the feasibility of implementing REN treatment during the prodrome to prevent migraine pain in youth with migraine, and hypothesize that:
- trial design will be feasible
- REN will be feasible for prodromal treatment, with >80% of participants using their assigned device to treat a qualifying prodrome.
The following feasibility and acceptability outcomes will be measured:
- proportion of eligible youth that are enrolled into the screening period, subsequently randomized, and treat a qualifying prodrome with REN.
- recruitment rate, retention, and withdrawals.
- participant feedback.
All secondary outcomes will be reported descriptively, and adverse events will be recorded and reported.
Methods:
This study will be a pilot randomized, single centre, double-blind, parallel group, sham-controlled trial comparing active to sham REN for the prevention of headache within 24 hours of treating prodromal symptoms in youth with migraine. Participants will be recruited from headache and neurology clinics at the Alberta Children's Hospital.
Eligible and consenting participants will complete an intake visit and enter a 60-day screening period where they will complete electronic daily diaries to determine prodrome or headache occurrence and features. Participants with 3-28 qualifying prodromes during screening, where >75% are followed by a headache within 6 hours, will be randomized 1:1 to treat one qualifying prodrome with active or sham REN over a 60-day treatment period. Participants will be trained on device use and will be instructed to not use any co-interventions during the qualifying prodrome; if headache onsets after the prodrome, participants will be instructed to use their typical acute treatment. During the treated prodrome, a survey will determine the presence, type, and number of prodromal symptoms. Surveys at 2, 24, and 48 hours post-treatment will record the presence or absence of headache, its characteristics, and AEs.
The randomization sequence will be prepared by a biostatistician and will follow randomly ordered blocks of four and six, with variable block sizes. Only research pharmacists will have access to this sequence to prepare consecutively numbered blinded and matched study kits. These kits will contain a restricted mobile phone with only the REN software application pre-installed.
- Conditions
- Migraine, Migraine Headache
- Being tested
- Active Remote Electrical Neuromodulation, Sham Remote Electrical Neuromodulation
- Keywords
- pediatric, migraine, headache, neuromodulation, prodrome, treatment, REN
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Remote Electrical NeuromodulationDevice
Also called REN
The REN device modulates the pain response in the brain using conditioned pain modulation to trigger an analgesic effect. This mechanism is achieved by electrically stimulating the C and Aδ nociceptive sensory nerves in the upper arm, just below the perceived pain threshold and above the depolarization threshold. Precise activation of these sensory nerves further triggers ascending pain pathways within the spinothalamic tract and brain stem. These pathways further activate descending pain inhibitory pathways within the brain stem to modulate incoming pain signals and produce an analgesic effect.
The active REN device involves 45 minutes of a modulated symmetrical biphasic square electrical pulse, modulated frequency of 100-120 Hz, pulse width of 400 µs, maximum of 40 mA, which modulates the pain response in the brain using conditioned pain modulation to trigger an analgesic effect.
Sham Remote Electrical NeuromodulationDevice
The sham REN device produces sensations comparable to the active REN device, appears identical to the active REN device, is also controlled wirelessly by a smartphone application, but uses lower stimulation parameters which were ineffective in adult trials. The sham REN device involves 45 minutes of modulated symmetrical biphasic square electrical pulse, modulated frequency of ~0.083 Hz and a modulated pulse width of 40-550 µs.
| Study group | Role | What they receive |
|---|---|---|
| Active REN | Active comparator | 45 minutes of a modulated symmetrical biphasic square electrical pulse, modulated frequency of 100-120 Hz, pulse width of 400 µs, maximum of 40 mA, which modulates the pain response in the brain using conditioned pain modulation to trigger an analgesic effect. Receives: Device: Active Remote Electrical Neuromodulation |
| Sham REN | Sham comparator | 45 minutes of modulated symmetrical biphasic square electrical pulse, modulated frequency of ~0.083 Hz and a modulated pulse width of 40-550 µs. The sham device produces sensations comparable to the active device, appears identical to the active device, is also controlled wirelessly by a smartphone application, but uses lower stimulation parameters which were ineffective in adult trials. Receives: Device: Sham Remote Electrical Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Proportion of Youth Enrolled Into Study
Proportion of eligible youth enrolled into screening period (target=50%).
Measured: From enrollment to completion of the feedback form (between 60 and 120 days later).
Feasibility - Proportion of Participants Randomized to Study Treatment
Proportion of youth enrolled into screening period subsequently randomized (target=33%).
Measured: From enrollment to completion of the feedback form (between 60 and 120 days later).
Feasibility - Proportion of Participants Using REN Treatment
Proportion of randomized youth treating a qualifying prodrome event (target=80%).
Measured: From enrollment to completion of the feedback form (between 60 and 120 days later).
Study Acceptability Based on Participant Feedback
Participant feedback will be assessed based on the completion of multiple choice and free text items in a feedback form. Multiple choice responses will be "Strongly Disagree", "Disagree", "Neutral", "Agree", and "Strongly Agree", with "Agree" and "Strongly Agree" suggesting the study is acceptable to participants. Multiple choices items will be from previously published work (PubMed ID: 27390769). Free text responses will be reviewed to determine overall positive or acceptable aspects of the study and negative or not acceptable aspects of the study.
Measured: 60 to 120 days after successful enrollment.
Secondary outcomes (1)
Effect Size Estimate
The main outcome that we will obtain an effect size estimate for will be the proportion of participants with absence of moderate-severe headache within 24 hours of prodromal treatment. All secondary outcomes will be reported descriptively, with a focus on describing the prevalence and consistency of prodromal symptoms as reported for the adult trial. For headache, pain severity will be measured using the 11-point pain numerical rating scale where 0 = no pain and 10 = the most intense pain imaginable (where a higher rating equals worse pain and worse outcomes). To align with International Headache Society and FDA guidelines for migraine trials, we will also use the 4-point pain severity scale (0=none, 1=mild, 2=moderate, 3=severe; higher ratings equal worse severity and outcomes), and participants will be asked about their most bothersome migraine associated symptom, and whether it is present or not.
Measured: From enrollment to completion of the feedback form (between 60 and 120 days later).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- The proposed study will be a pilot randomized, single centre, double-blind, parallel group, sham-controlled trial comparing active to sham REN for the prevention of headache within 24 hours of treating prodromal symptoms in children and adolescents with migraine.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serena Orr, MD, MSc, FRCPC, University of Calgary
- Investigators
- Serena L Orr, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772427
- Sponsor's protocol ID
- REB26-1157
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregate data will be reported and there are currently no plans to share the individual participant data outside of the research team.
Publications
Hershey AD, Irwin S, Rabany L, Gruper Y, Ironi A, Harris D, Sharon R, McVige J. Comparison of Remote Electrical Neuromodulation and Standard-Care Medications for Acute Treatment of Migraine in Adolescents: A Post Hoc Analysis. Pain Med. 2022 Apr 8;23(4):815-820. doi: 10.1093/pm/pnab197.
PubMed 34185084Hershey AD, Lin T, Gruper Y, Harris D, Ironi A, Berk T, Szperka CL, Berenson F. Remote electrical neuromodulation for acute treatment of migraine in adolescents. Headache. 2021 Feb;61(2):310-317. doi: 10.1111/head.14042. Epub 2020 Dec 21.
PubMed 33349920Martin EG, Rasiah J, Claassen CS, Waywitka J, Merritt AM, Pringsheim TM, Shearer KA, Tsang VWL, Stevens KE, Sheehan-Klassen CE, Suddaby P, Orr SL. Engaging youth and parents in clinical pediatric research: A case-based example. Paediatr Child Health. 2023 Mar 31;28(4):235-240. doi: 10.1093/pch/pxac111. eCollection 2023 Jul.
PubMed 37287482Goadsby PJ, Zanchin G, Geraud G, de Klippel N, Diaz-Insa S, Gobel H, Cunha L, Ivanoff N, Falques M, Fortea J. Early vs. non-early intervention in acute migraine-'Act when Mild (AwM)'. A double-blind, placebo-controlled trial of almotriptan. Cephalalgia. 2008 Apr;28(4):383-91. doi: 10.1111/j.1468-2982.2008.01546.x. Epub 2008 Feb 20.
PubMed 18294251Dodick DW, Goadsby PJ, Schwedt TJ, Lipton RB, Liu C, Lu K, Yu SY, Severt L, Finnegan M, Trugman JM. Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023 Dec 16;402(10419):2307-2316. doi: 10.1016/S0140-6736(23)01683-5. Epub 2023 Nov 15.
PubMed 37979595Coppola G, Bracaglia M, Di Lenola D, Iacovelli E, Di Lorenzo C, Serrao M, Evangelista M, Parisi V, Schoenen J, Pierelli F. Lateral inhibition in the somatosensory cortex during and between migraine without aura attacks: Correlations with thalamocortical activity and clinical features. Cephalalgia. 2016 May;36(6):568-78. doi: 10.1177/0333102415610873. Epub 2015 Oct 6.
PubMed 26442930Cho LY, Bell TK, Craddock L, Godfrey KJ, Hershey AD, Kuziek J, Stokoe M, Millar K, Orr SL, Harris AD. Region-specific changes in brain glutamate and gamma-aminobutyric acid across the migraine attack in children and adolescents. Pain. 2024 Dec 1;165(12):2749-2761. doi: 10.1097/j.pain.0000000000003289. Epub 2024 Jun 4.
PubMed 38833578
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation During the Prodrome to Prevent Disabling Migraine Attacks in Children and Adolescents - a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07772427
- Acronym / sponsor ID
- REB26-1157
- Conditions
- Migraine, Migraine Headache
- Keywords
- pediatric, migraine, headache, neuromodulation, prodrome, treatment, REN
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 19 Aug 2026 (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.
Background \& Rationale:
One in ten Canadian youth have migraine, a disabling neurological disease that is more common in females and characterized by moderate-severe disabling headaches. Migraine attacks occur in a cycle that begins with a prodromal phase, followed by aura, a pain phase (headache), and finally a postdrome phase when the pain is resolved but other symptoms persist. The prodrome is recognized by ~90% of all youth with migraine, occurs up to 24 hours before headache onset, and consists of a variety of symptoms including, but not limited to, food cravings, fatigue, yawning, mood changes, and sensory hypersensitivity (e.g., light sensitivity). Prodromal symptoms are disabling and frequently graded as moderate to severe. All acute migraine treatments for youth have been studied for use in the pain phase, with the greatest treatment success early in this phase. Unfortunately, only ~1/3 of youth achieve pain freedom within two hours. Recently, a groundbreaking trial found that treatment during the prodrome could prevent the pain phase, although prodromal treatment does not exist for youth.
In considering the most innovative, safe, and patient-centered prodromal intervention, remote electrical neuromodulation (REN) is the obvious choice. The investigator's engagement with 175 youth with migraine and their caregivers shows that REN is preferred when pill-based interventions are ineffective or impractical. REN has none of the limitations of pill-based prodromal treatment. The REN device is wearable, battery-operated, worn on the upper arm, and controlled wirelessly by a smartphone application. REN electrically stimulates sensory nerves in the arm below their perceived pain thresholds, but above their depolarization thresholds, to induce a conditioned pain modulation response in the brain to modulate incoming migraine pain signals.
Clinical trial and observational studies in youth with migraine have shown REN's safety and efficacy for home-based treatment during the pain phase and led the FDA to clear its use in youth >8 years. In the adolescent trial, 71% of participants had pain relief at two hours, there were no serious adverse events (AE), and only one device-related AE (transient arm pain) occurred. Also, emerging data show that adults with migraine in the prodrome phase display pain facilitation due to a deficit in pain modulation. Thus, REN's mechanism of action is likely to be more effective during the prodrome vs. the pain phase as it can "turn on" deficient pain modulatory areas earlier when they are most impaired.
Research Question \& Objectives:
The investigators aim to determine the feasibility of implementing REN treatment during the prodrome to prevent migraine pain in youth with migraine, and hypothesize that:
- trial design will be feasible
- REN will be feasible for prodromal treatment, with >80% of participants using their assigned device to treat a qualifying prodrome.
The following feasibility and acceptability outcomes will be measured:
- proportion of eligible youth that are enrolled into the screening period, subsequently randomized, and treat a qualifying prodrome with REN.
- recruitment rate, retention, and withdrawals.
- participant feedback.
All secondary outcomes will be reported descriptively, and adverse events will be recorded and reported.
Methods:
This study will be a pilot randomized, single centre, double-blind, parallel group, sham-controlled trial comparing active to sham REN for the prevention of headache within 24 hours of treating prodromal symptoms in youth with migraine. Participants will be recruited from headache and neurology clinics at the Alberta Children's Hospital.
Eligible and consenting participants will complete an intake visit and enter a 60-day screening period where they will complete electronic daily diaries to determine prodrome or headache occurrence and features. Participants with 3-28 qualifying prodromes during screening, where >75% are followed by a headache within 6 hours, will be randomized 1:1 to treat one qualifying prodrome with active or sham REN over a 60-day treatment period. Participants will be trained on device use and will be instructed to not use any co-interventions during the qualifying prodrome; if headache onsets after the prodrome, participants will be instructed to use their typical acute treatment. During the treated prodrome, a survey will determine the presence, type, and number of prodromal symptoms. Surveys at 2, 24, and 48 hours post-treatment will record the presence or absence of headache, its characteristics, and AEs.
The randomization sequence will be prepared by a biostatistician and will follow randomly ordered blocks of four and six, with variable block sizes. Only research pharmacists will have access to this sequence to prepare consecutively numbered blinded and matched study kits. These kits will contain a restricted mobile phone with only the REN software application pre-installed.
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
- The proposed study will be a pilot randomized, single centre, double-blind, parallel group, sham-controlled trial comparing active to sham REN for the prevention of headache within 24 hours of treating prodromal symptoms in children and adolescents with migraine.
| Arm | Type | Receives |
|---|---|---|
| Active REN | Active comparator | Device: Active Remote Electrical Neuromodulation45 minutes of a modulated symmetrical biphasic square electrical pulse, modulated frequency of 100-120 Hz, pulse width of 400 µs, maximum of 40 mA, which modulates the pain response in the brain using conditioned pain modulation to trigger an analgesic effect. |
| Sham REN | Sham comparator | Device: Sham Remote Electrical Neuromodulation45 minutes of modulated symmetrical biphasic square electrical pulse, modulated frequency of ~0.083 Hz and a modulated pulse width of 40-550 µs. The sham device produces sensations comparable to the active device, appears identical to the active device, is also controlled wirelessly by a smartphone application, but uses lower stimulation parameters which were ineffective in adult trials. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- youth aged 8-<18 years with a diagnosis of migraine using gold standard International Classification of Headache Disorders criteria
- self-reporting 2-14 headache days/month in the last 3 months
- reporting prodromal symptoms that predict a headache within six hours >75% of the time.
- To proceed past the 60-day screening period to randomization, participants will need to report 3-28 qualifying prodrome events with >75% of these events followed by a headache within 6 hours.
Key exclusion criteria (8 listed)
- the inability to read or understand English
- a diagnosis of psychosis, schizophrenia, or moderate-severe autism, moderate-severe developmental delay or moderate-severe intellectual disability
- implanted electrical device
- uncontrolled epilepsy (i.e., >2 seizures in the past year)
- abnormal skin on both upper arms
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 |
|---|---|---|
| Active Remote Electrical NeuromodulationAlso: RENThe REN device modulates the pain response in the brain using conditioned pain modulation to trigger an analgesic effect. This mechanism is achieved by electrically stimulating the C and Aδ nociceptive sensory nerves in the upper arm, just below the perceived pain threshold and above the depolarization threshold. Precise activation of these sensory nerves further triggers ascending pain pathways within the spinothalamic tract and brain stem. These pathways further activate descending pain inhibitory pathways within the brain stem to modulate incoming pain signals and produce an analgesic effect. The active REN device involves 45 minutes of a modulated symmetrical biphasic square electrical pulse, modulated frequency of 100-120 Hz, pulse width of 400 µs, maximum of 40 mA, which modulates the pain response in the brain using conditioned pain modulation to trigger an analgesic effect. | Device | Active REN |
| Sham Remote Electrical NeuromodulationThe sham REN device produces sensations comparable to the active REN device, appears identical to the active REN device, is also controlled wirelessly by a smartphone application, but uses lower stimulation parameters which were ineffective in adult trials. The sham REN device involves 45 minutes of modulated symmetrical biphasic square electrical pulse, modulated frequency of ~0.083 Hz and a modulated pulse width of 40-550 µs. | Device | Sham REN |
Primary outcome
Feasibility - Proportion of Youth Enrolled Into Study
Time frame: From enrollment to completion of the feedback form (between 60 and 120 days later).
Proportion of eligible youth enrolled into screening period (target=50%).
Feasibility - Proportion of Participants Randomized to Study Treatment
Time frame: From enrollment to completion of the feedback form (between 60 and 120 days later).
Proportion of youth enrolled into screening period subsequently randomized (target=33%).
Feasibility - Proportion of Participants Using REN Treatment
Time frame: From enrollment to completion of the feedback form (between 60 and 120 days later).
Proportion of randomized youth treating a qualifying prodrome event (target=80%).
Study Acceptability Based on Participant Feedback
Time frame: 60 to 120 days after successful enrollment.
Participant feedback will be assessed based on the completion of multiple choice and free text items in a feedback form. Multiple choice responses will be "Strongly Disagree", "Disagree", "Neutral", "Agree", and "Strongly Agree", with "Agree" and "Strongly Agree" suggesting the study is acceptable to participants. Multiple choices items will be from previously published work (PubMed ID: 27390769). Free text responses will be reviewed to determine overall positive or acceptable aspects of the study and negative or not acceptable aspects of the study.
1 secondary outcome
Effect Size Estimate
Time frame: From enrollment to completion of the feedback form (between 60 and 120 days later).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 34185084Hershey AD, Irwin S, Rabany L, Gruper Y, Ironi A, Harris D, Sharon R, McVige J. Comparison of Remote Electrical Neuromodulation and Standard-Care Medications for Acute Treatment of Migraine in Adolescents: A Post Hoc Analysis. Pain Med. 2022 Apr 8;23(4):815-820. doi: 10.1093/pm/pnab197.
- Background: PubMed 33349920Hershey AD, Lin T, Gruper Y, Harris D, Ironi A, Berk T, Szperka CL, Berenson F. Remote electrical neuromodulation for acute treatment of migraine in adolescents. Headache. 2021 Feb;61(2):310-317. doi: 10.1111/head.14042. Epub 2020 Dec 21.
- Background: PubMed 37287482Martin EG, Rasiah J, Claassen CS, Waywitka J, Merritt AM, Pringsheim TM, Shearer KA, Tsang VWL, Stevens KE, Sheehan-Klassen CE, Suddaby P, Orr SL. Engaging youth and parents in clinical pediatric research: A case-based example. Paediatr Child Health. 2023 Mar 31;28(4):235-240. doi: 10.1093/pch/pxac111. eCollection 2023 Jul.
- Background: PubMed 18294251Goadsby PJ, Zanchin G, Geraud G, de Klippel N, Diaz-Insa S, Gobel H, Cunha L, Ivanoff N, Falques M, Fortea J. Early vs. non-early intervention in acute migraine-'Act when Mild (AwM)'. A double-blind, placebo-controlled trial of almotriptan. Cephalalgia. 2008 Apr;28(4):383-91. doi: 10.1111/j.1468-2982.2008.01546.x. Epub 2008 Feb 20.
- Background: PubMed 37979595Dodick DW, Goadsby PJ, Schwedt TJ, Lipton RB, Liu C, Lu K, Yu SY, Severt L, Finnegan M, Trugman JM. Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023 Dec 16;402(10419):2307-2316. doi: 10.1016/S0140-6736(23)01683-5. Epub 2023 Nov 15.
- Background: PubMed 26442930Coppola G, Bracaglia M, Di Lenola D, Iacovelli E, Di Lorenzo C, Serrao M, Evangelista M, Parisi V, Schoenen J, Pierelli F. Lateral inhibition in the somatosensory cortex during and between migraine without aura attacks: Correlations with thalamocortical activity and clinical features. Cephalalgia. 2016 May;36(6):568-78. doi: 10.1177/0333102415610873. Epub 2015 Oct 6.
- Background: PubMed 38833578Cho LY, Bell TK, Craddock L, Godfrey KJ, Hershey AD, Kuziek J, Stokoe M, Millar K, Orr SL, Harris AD. Region-specific changes in brain glutamate and gamma-aminobutyric acid across the migraine attack in children and adolescents. Pain. 2024 Dec 1;165(12):2749-2761. doi: 10.1097/j.pain.0000000000003289. Epub 2024 Jun 4.
- Individual participant dataSharing planned: No. Only aggregate data will be reported and there are currently no plans to share the individual participant data outside of the research team.
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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.
Serena L Orr principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Remote Electrical Neuromodulation in people with Migraine and Migraine Headache, run by University of Calgary at 1 site in Canada.
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 4 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: opening soon, as of the sponsor's last update on 19 Aug 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serena L Orr, MD, MSc, FRCPC ((403) 955-7728, serena.orr@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Proportion of Youth Enrolled Into Study (time frame: From enrollment to completion of the feedback form (between 60 and 120 days later).). The study lists 4 primary outcomes in all. 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 NCT07772427, which also lists 7 linked publications.
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 19 Aug 2026.