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The trigeminovasCuLar rEflex in migrAine patients having an implantable cRANiofaCial nEurostimulator using the forehead model

The trigeminovasCuLar rEflex in migrAine patients having an implantable cRANiofaCial nEurostimulator: evaluation of the feasibility of using the forehead model - The trigeminovascular reflex in migraine patients with an implantable craniofacial neurostimulator using the forehead model

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58228
Enrollment
2
Registered
2025-08-19
Start date
2026-03-13
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine, headache disorders, primary headache disorders Migraine, severe headache

Interventions

Participants will undergo three LSCI sessions. On Day 1, saline will be applied to forehead reservoirs to test feasibility and signal quality. On Day 2, capsaicin solution will be applied to induce tr

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Signed written informed consent.Participant is currently responding to MySalvia therapy in the RELIEF study (defined as =30% reduction in monthly migraine days compared to baseline).Willing and able to comply with study requirements, including travel to Rotterdam

Exclusion criteria

Exclusion criteria: Skin conditions on the forehead that may interfere with measurementsSerious medical or psychiatric conditions that may compromise participation (e.g., HIV, hepatitis B/C, cancer, psychiatric disorders according to DSM-5 such as depression, schizophrenia, suicidality).History of allergy or sensitivity to capsicum fruits (e.g., chili peppers).Other: insufficient mastery of Dutch or English; current substance dependence (alcohol, illicit drugs, tranquilizers, narcotics, analgesics). 

Design outcomes

Primary

MeasureTime frame
The total number of artefacts during LSCI measurements aggregated for Day 1 and Day 2, stratified by baseline and active stimulation.

Secondary

MeasureTime frame
Optimal reservoir placement (based on artefact frequency) and dermal blood flow parameters in response to capsaicin with and without stimulation, including maximal response (?Emax) and area under the curve (AUC0–40).

Countries

Netherlands

Contacts

Public ContactN.R.A. Bruijn

Erasmus MC, Universitair Medisch Centrum Rotterdam

n.bruijn@erasmusmc.nl0107043547

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026