Primary Objective: To assess real-world long-term efficacy and tolerability of occipital nerve stimulation (ONS) in medically intractable chronic cluster headache patients Secondary Objectives: - To obtain real world data of effect of ONS on quality…
ID
Source
Brief title
Condition
- Other condition
- Headaches
Synonym
Health condition
Hoofdpijn/chronische pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Average number of weekly attacks 1, 2 and 5 years after ONS implantation
compared to baseline
Secondary outcome
- Average score on the SF-36 and HADS 1, 2 and 5 years after ONS implantation
compared to baseline
- Average attack intensity 1,2 and 5 years after ONS implantation compared to
baseline
- Use of prophylactic medication 1,2 and 5 years after ONS implantation
compared to baseline
- Average weekly use of attack medication and oxygen 1,2 and 5 years after ONS
implantation compared to baseline
- Side effects
- Number of revisions and battery replacements necessary
- Drop-out during the 5 years study period
Background summary
Occipital nerve stimulation (ONS) is a relatively new, invasive, reversible
preventive treatment for medically intractable chronic cluster headache (MICCH)
and has recently been approved for reimbursement by the Dutch health authority.
This approval was based on the preliminary positive results of the *occipital
nerve stimulation in medically intractable chronic cluster headache* (ICON)
trial that investigated a high vs low stimulation protocol. Since ONS is a
relatively new treatment method, real life clinical follow up data to determine
effect and tolerability is warranted. Furthermore, this data can be used to
identify possible factors predicting effect.
Study objective
Primary Objective:
To assess real-world long-term efficacy and tolerability of occipital nerve
stimulation (ONS) in medically intractable chronic cluster headache patients
Secondary Objectives:
- To obtain real world data of effect of ONS on quality of life
- To obtain real world data of effect of ONS on anxiety and depression
- To identify possible factors predicting effect
- To evaluate the use of acute.medication and oxygen use during ONS treatment
Study design
Multicenter observational study
Study burden and risks
The risks of the proposed study are very low since this is an observational
study. It is very important to gain a detailed clinical follow up of this new
treatment to determine real world efficacy, identify possible predictive
factors, and to gain a better understanding of the mechanism of action.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
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
NA
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75958.058.20 |