Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine
TMS-CHROMIG
1 other identifier
interventional
18
1 country
1
Brief Summary
The purpose of this study is to determine whether active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex is safe and effective for preventive treatment of chronic migraine, compared to placebo repetitive transcranial magnetic stimulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2008
Typical duration for phase_1
1 active site
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
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedFirst Posted
Study publicly available on registry
December 21, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedApril 5, 2018
April 1, 2018
3.2 years
May 25, 2011
April 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of days with pain per month
After all treatment sessions (total, 23 sessions within 60 days)
Secondary Outcomes (1)
adverse effects
After all treatment sessions (total, 23 sessions within 60 days)
Study Arms (2)
Active Comparator: Active rTMS
ACTIVE COMPARATOR10Hz active rTMS delivered to the left dorsolateral prefrontal cortex
Placebo
PLACEBO COMPARATOR10Hz placebo rTMS delivered to the vertex
Interventions
10Hz active rTMS delivered to the left dorsolateral prefrontal cortex
10Hz placebo rTMS delivered to the vertex
Eligibility Criteria
You may qualify if:
- chronic migraine according to the criteria of the International Headache Society
- no change in prophylactic medication in the past 3 months
You may not qualify if:
- other neurological disorders
- bipolar disorder
- alcohol or drug dependence in the past 2 months
- suicidal ideation, psychotic symptoms
- contraindications to transcranial magnetic stimulation (cardiac pacemaker, implanted electronic devices, metal in the skull, skull fractures, history of seizures)
- use of antidepressants in the past 4 weeks
- pregnancy or lack of birth-control method in women of childbearing age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Israelita de Ensino e Pesquisa Albert Einstein
São Paulo, 05652901, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adriana Conforto, MD,PHD
Instituto Israelita de Ensino e Pesquisa Albert Einstein
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology, MD PhD
Study Record Dates
First Submitted
May 25, 2011
First Posted
December 21, 2011
Study Start
October 1, 2008
Primary Completion
December 1, 2011
Study Completion
February 1, 2012
Last Updated
April 5, 2018
Record last verified: 2018-04