Back to resultsDouble-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine (TMS-CHROMIG)
Primary Purpose
Chronic Migraine
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
10Hz active rTMS
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Migraine focused on measuring migraine
Eligibility Criteria
Inclusion Criteria:
- chronic migraine according to the criteria of the International Headache Society
- no change in prophylactic medication in the past 3 months
Exclusion Criteria:
- 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
Sites / Locations
- Instituto Israelita de Ensino e Pesquisa Albert Einstein
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active Comparator: Active rTMS
Placebo
Arm Description
10Hz active rTMS delivered to the left dorsolateral prefrontal cortex
10Hz placebo rTMS delivered to the vertex
Outcomes
Primary Outcome Measures
number of days with pain per month
Secondary Outcome Measures
adverse effects
Full Information
NCT ID
NCT01496950
First Posted
May 25, 2011
Last Updated
April 4, 2018
Sponsor
Hospital Israelita Albert Einstein
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT01496950
Brief Title
Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine
Acronym
TMS-CHROMIG
Official Title
Double-blind Randomized Clinical Trial to Evaluate Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in the Preventive Treatment of Chronic Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Israelita Albert Einstein
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Patients with chronic migraine according to the criteria of the International Headache Society will be randomized to either active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex or placebo repetitive transcranial magnetic stimulation, in a total of 23 sessions of treatment (15 sessions in the first month and 8 sessions in the second month of treatment). Outcomes will be evaluated at baseline, after one, two months after treatment, and one month after end of treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine
Keywords
migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Comparator: Active rTMS
Arm Type
Active Comparator
Arm Description
10Hz active rTMS delivered to the left dorsolateral prefrontal cortex
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
10Hz placebo rTMS delivered to the vertex
Intervention Type
Device
Intervention Name(s)
10Hz active rTMS
Other Intervention Name(s)
Repetitive transcranial magnetic stimulation
Intervention Description
10Hz active rTMS delivered to the left dorsolateral prefrontal cortex
Intervention Type
Device
Intervention Name(s)
Placebo
Other Intervention Name(s)
Repetitive transcranial magnetic stimulation
Intervention Description
10Hz placebo rTMS delivered to the vertex
Primary Outcome Measure Information:
Title
number of days with pain per month
Time Frame
After all treatment sessions (total, 23 sessions within 60 days)
Secondary Outcome Measure Information:
Title
adverse effects
Time Frame
After all treatment sessions (total, 23 sessions within 60 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic migraine according to the criteria of the International Headache Society
no change in prophylactic medication in the past 3 months
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Conforto, MD,PHD
Organizational Affiliation
Instituto Israelita de Ensino e Pesquisa Albert Einstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Israelita de Ensino e Pesquisa Albert Einstein
City
São Paulo
ZIP/Postal Code
05652901
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine
We'll reach out to this number within 24 hrs