Chronic Migraine Headache
Conditions
Brief summary
Background: Medically intractable chronic migraine (CM) is a disabling illness characterized by headache greater than 15 days per month. Method: A multicenter, randomized, blinded, controlled feasibility study was conducted to obtain preliminary safety and efficacy data on occipital nerve stimulation (ONS) in CM. Eligible subjects received an occipital nerve block, and responsers were randomized to adjustable stimulation (AS), preset stimulation (PS) or medical management (MM) groups.
Detailed description
The therapy under investigation involves a Medtronic neurostimulation device which delivers electrical impulses via insulated lead wires placed under the skin near the occipital nerves at the base of the head.
Interventions
Each group had a different plan
Sponsors
MedtronicNeuro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Chronic Migraine Headache by International Headache Society (IHS) criteria * compliance with daily questionnaire * headache that has not responded to at least two classes of headache medications * stable headache medication regimen
Exclusion criteria
* previous surgical procedures to disrupt the nerves of the neck relating to the headache * subjects who may require MRI or Diathermy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A primary endpoint is not identified for this feasibility study. | No primary endpoint |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints included: patient daily questionnaire, Migraine Disability Assessment (MIDAS), functional disability, SF-36, acute medication use and subject satisfaction surveys. | No secondary endpoint |
Countries
Canada, United Kingdom, United States
Outcome results
None listed