tDCS in Chronic Migraine With Medication Overuse (Edisom)
Edisom
Long-term Efficacy of Transcranial Direct Current Stimulation in Chronic Migraine With Medication Overuse: a Phase III, Placebo Controlled, Randomised Clinical Trial (Edisom)
1 other identifier
interventional
135
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2018
CompletedFirst Submitted
Initial submission to the registry
January 4, 2020
CompletedFirst Posted
Study publicly available on registry
January 14, 2020
CompletedFebruary 17, 2020
February 1, 2020
1.6 years
January 4, 2020
February 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
days of headache per month (long-term)
no. patients with 50% reduction of days of headache per month
12 months
Secondary Outcomes (8)
days of headache per month (mid-term)
6 months
analgesic intake per month
6 and 12 months
disability
6 and 12 months
catastrophizing attitude
6 and 12 months
depression
6 and 12 months
- +3 more secondary outcomes
Study Arms (3)
anodal tDCS
EXPERIMENTALanodal tDCS stimulation
cathodal tDCS
ACTIVE COMPARATORcathodal tDCS stimulation
sham tDCS
PLACEBO COMPARATORsham tDCS stimulation (stopped after 30 seconds)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Grazzi L, Usai S, Bolognini N, Grignani E, Sansone E, Tramacere I, Maravita A, Lauria G. No efficacy of transcranial direct current stimulation on chronic migraine with medication overuse: A double blind, randomised clinical trial. Cephalalgia. 2020 Oct;40(11):1202-1211. doi: 10.1177/0333102420931050. Epub 2020 Jun 14.
PMID: 32536270DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- sham
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2020
First Posted
January 14, 2020
Study Start
December 1, 2015
Primary Completion
June 30, 2017
Study Completion
May 30, 2018
Last Updated
February 17, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share