Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine (TMS-CHROMIG)
This study is currently recruiting participants.
Verified December 2011 by Hospital Israelita Albert Einstein
Sponsor:
Hospital Israelita Albert Einstein
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Adriana Conforto, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier:
NCT01496950
First received: May 25, 2011
Last updated: December 19, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Migraine |
Device: 10Hz active rTMS Device: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Double-blind Randomized Clinical Trial to Evaluate Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in the Preventive Treatment of Chronic Migraine |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial hemiplegic migraine
MedlinePlus related topics:
Migraine
U.S. FDA Resources
Further study details as provided by Hospital Israelita Albert Einstein:
Primary Outcome Measures:
- number of days with pain per month [ Time Frame: After all treatment sessions (total, 23 sessions within 60 days) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- adverse effects [ Time Frame: After all treatment sessions (total, 23 sessions within 60 days) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Active Comparator: Active rTMS
10Hz active rTMS delivered to the left dorsolateral prefrontal cortex
|
Device: 10Hz active rTMS
10Hz active rTMS delivered to the left dorsolateral prefrontal cortex
Other Name: Repetitive transcranial magnetic stimulation
|
|
Placebo Comparator: Placebo
10Hz placebo rTMS delivered to the vertex
|
Device: Placebo
10Hz placebo rTMS delivered to the vertex
Other Name: 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
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496950
Contacts
| Contact: Adriana Conforto, MD,PhD | adriana.conforto@gmail.com |
Locations
| Brazil | |
| Instituto Israelita de Ensino e Pesquisa Albert Einstein | Recruiting |
| São Paulo, Brazil, 05652901 | |
| Contact: Adriana Conforto, MD, PhD adriana.conforto@gmail.com | |
| Sub-Investigator: Mario Fernando P Peres, MD,PhD | |
| Sub-Investigator: Edson Amaro Jr, MD, PHD | |
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
| Principal Investigator: | Adriana Conforto, MD,PHD | Instituto Israelita de Ensino e Pesquisa Albert Einstein |
More Information
No publications provided
| Responsible Party: | Adriana Conforto, Professor of Neurology, MD PhD, Hospital Israelita Albert Einstein |
| ClinicalTrials.gov Identifier: | NCT01496950 History of Changes |
| Other Study ID Numbers: | IIEP394-07 |
| Study First Received: | May 25, 2011 |
| Last Updated: | December 19, 2011 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Hospital Israelita Albert Einstein:
|
migraine |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013