Occipital nerve stimulation: Real-world long-term clinical follow up in medically intractable cluster headache

Occipital nerve stimulation: Real-world long-term clinical follow up in medically intractable cluster headache - Long term follow-up of ONS in MICCH

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51040

Enrollment

100

Registered

2020-11-18

Start date

2021-11-22

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Hortons neuralgia neuralgia of Horton Cluster Headache

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Diagnosis of MICCH, according to the ICHD-III criteria and the ICON trial guidelines: o No relevant effect on maximum dosage or o Severe side effect or o Contra-indication for At least three prophylactic drugs including * Verapamil * Lithium * Topiramate Patients should be receiving ONS implantation as part of clinical care Patients have to be aged 18 years or older Adequate control of the Dutch language The ability and possibility to use an e-device

Exclusion criteria

Exclusion criteria: NA

Design outcomes

Primary

Measure	Time frame
Average number of weekly attacks 1, 2, 5 and 10 years after ONS implantation compared to baseline	—

Secondary

Measure	Time frame
- Average score on the SF-36 and HADS 1, 2, 5 and 10 years after ONS implantation compared to baseline - Average attack intensity 1, 2, 5 and 10 years after ONS implantation compared to baseline - Use of prophylactic medication 1, 2, 5 and 10 years after ONS implantation compared to baseline - Average weekly use of attack medication and oxygen 1, 2, 5 and 10 years after ONS implantation compared to baseline - Side effects - Number of revisions and battery replacements necessary - Drop-out during the 10 years study period	—

Measure

Time frame

- Average score on the SF-36 and HADS 1, 2, 5 and 10 years after ONS implantation compared to baseline - Average attack intensity 1, 2, 5 and 10 years after ONS implantation compared to baseline - Use of prophylactic medication 1, 2, 5 and 10 years after ONS implantation compared to baseline - Average weekly use of attack medication and oxygen 1, 2, 5 and 10 years after ONS implantation compared to baseline - Side effects - Number of revisions and battery replacements necessary - Drop-out during the 10 years study period

—

Countries

Netherlands

Contacts

Public Contactvan Liefland

Leids Universitair Medisch Centrum

w.c.naber@lumc.nl0705262147

Outcome results