Medication Overuse Headache, Migraine Disorders
Conditions
Brief summary
Transcranial direct current stimulation (tDCS) was suggested to provide beneficial effects in chronic migraine (CM), a condition often associated with medication overuse (MO) for which no long-term therapy is available.
Detailed description
We conducted a randomized controlled trial to assess long-term efficacy of tDCS. Adults diagnosed with CM and MO were assigned to receive in a 1:1:1 ratio anodal, cathodal, or sham tDCS daily for five consecutive days, along with standardized drug withdrawal protocol with intravenous administration of dexamethasone 4 mg and ademetionine 200 mg in saline solution, and oral bromazepam 1.5 mg three times daily. Primary outcome was 50% reduction of days of headache per month at 12 months. Co-secondary outcomes were 50% reduction of days of headache per month at 6 months, reduction of analgesic intake per month, and change in disability and quality of life, catastrophizing, depression, state and trait anxiety, dependence attitude and allodynia intensity. Patients were not allowed to take any migraine prophylaxis drug for the entire study period.
Interventions
DEVICEtDCS
transcranial direct current stimulation
Sponsors
University of Milano Bicocca
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
sham
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* chronic migraine with medication overuse according to the International Headache Society criteria. Diagnosis was confirmed on the basis of a daily headache diary that all eligible patients filled out in the last month prior to the enrollment. Patients should have failed at least two prophylaxis therapies. Written informed consent.
Exclusion criteria
* known diagnosis of major depression or other major psychiatric disorders identified after psychiatric consultation, cardiac pace maker, clips for previous head surgery, cochlear implant, history of epilepsy, known idiopathic intracranial hypertension, harmful alcohol consumption, pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| days of headache per month (long-term) | 12 months | no. patients with 50% reduction of days of headache per month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| analgesic intake per month | 6 and 12 months | percentage of reduction of analgesic intake per month compared to baseline |
| disability | 6 and 12 months | Migraine Disability Assessment (MIDAS). MIDAS-score 0-:5 low disability 6-10: MILD disability 11-20: Moderate disability more than 2:0 Severe disability. |
| catastrophizing attitude | 6 and 12 months | Pain Catastrophizing Scale (PCS) pathological more than 30 (total score) no cut off for the subscales |
| days of headache per month (mid-term) | 6 months | no. patients with 50% reduction of days of headache per month |
| state and trait anxiety | 6 and 12 months | Spielberger questionnaires STAIY1-Y2 ; score between 20-80 |
| dependence attitude | 6 and 12 months | Leed questionnaire score Under 10: low dependency 10-22: medium dependency more than 22: high dependency |
| allodynia intensity | 6 and 12 months | Allodynia Symptoms Checklist |
| depression | 6 and 12 months | Beck Depression Inventory (BDI) score more than 7 |
Outcome results
None listed