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Completed

NCT Number: NCT04228809

tDCS in Chronic Migraine With Medication Overuse (Edisom)

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tDCS

Device

transcranial direct current stimulation

Primary outcomes

  1. days of headache per month (long-term)

    Time frame: 12 months

    no. patients with 50% reduction of days of headache per month

Secondary outcomes

  1. days of headache per month (mid-term)

    Time frame: 6 months

    no. patients with 50% reduction of days of headache per month

  2. analgesic intake per month

    Time frame: 6 and 12 months

    percentage of reduction of analgesic intake per month compared to baseline

  3. disability

    Time frame: 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.

  4. catastrophizing attitude

    Time frame: 6 and 12 months

    Pain Catastrophizing Scale (PCS) pathological more than 30 (total score) no cut off for the subscales

  5. depression

    Time frame: 6 and 12 months

    Beck Depression Inventory (BDI) score more than 7

  6. state and trait anxiety

    Time frame: 6 and 12 months

    Spielberger questionnaires STAIY1-Y2 ; score between 20-80

  7. dependence attitude

    Time frame: 6 and 12 months

    Leed questionnaire score

    Under 10: low dependency

    10-22: medium dependency

    more than 22: high dependency

  8. allodynia intensity

    Time frame: 6 and 12 months

    Allodynia Symptoms Checklist

Sponsors and collaborators

Lead sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Other

Collaborators

  • University of Milano Bicocca

Registry information

Official study title

Long-term Efficacy of Transcranial Direct Current Stimulation in Chronic Migraine With Medication Overuse: a Phase III, Placebo Controlled, Randomised Clinical Trial (Edisom)

Acronym: Edisom

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jan 14, 2020
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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