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Transcranial Direct Current Simulation in Chronic Migraine

This study is currently recruiting participants.
Verified June 2016 by Suellen Marinho Andrade, Federal University of Paraíba
Sponsor:
ClinicalTrials.gov Identifier:
NCT02817139
First Posted: June 29, 2016
Last Update Posted: June 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Suellen Marinho Andrade, Federal University of Paraíba
  Purpose
This study is a pilot, double-blind, placebo-controlled, randomized trial aiming to compare the effects of transcranial direct current stimulation in Chronic Migraine.

Condition Intervention Phase
Migraine Disorders Device: TDCS Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Simulation Over Primary Motor vs Prefrontal Cortex in Chronic Migraine: a Pilot Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Suellen Marinho Andrade, Federal University of Paraíba:

Primary Outcome Measures:
  • Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6) [ Time Frame: Baseline (week 1) and Endpoint (week 4) ]

Secondary Outcome Measures:
  • Change in pain assessed on the Visual Analogue Scale (VAS) [ Time Frame: Baseline (week 1) and Endpoint (week 4) ]
  • Change in quality of life assessed on the Medical Outcomes Study 36 - Item Short - Form Health Survey(SF-36) [ Time Frame: Baseline (week 1) and and Endpoint (week 4) ]
  • Side Effects Questionnaire [ Time Frame: From date of first neurostimulation until the date of last neurostimulation, , assessed up to 1 month ]

Estimated Enrollment: 15
Study Start Date: June 2016
Estimated Study Completion Date: September 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: active tDCS over primary motor cortex
Duration: 20 minutes; Intensity: 2 mA; Placement: left primary motor cortex.
Device: TDCS
Other Name: Transcranial Direct Current Stimulation
Experimental: active tDCS over prefrontal cortex
Duration: 20 minutes; Intensity: 2 mA; Placement: left prefrontal cortex.
Device: TDCS
Other Name: Transcranial Direct Current Stimulation
Placebo Comparator: sham tDCS over primary motor cortex
Duration: 20 minutes; The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham; Placement: left primary motor cortex.
Device: TDCS
Other Name: Transcranial Direct Current Stimulation

Detailed Description:
The patients will be randomized into 1 of 3 groups: active tDCS over primary motor cortex, active tDCS over prefrontal cortex, sham tDCS. Each group will receive treatment for 20 minutes a day, 3 days a week for 4 weeks.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with a clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta) of the International Headache Society, with an established headache history occurring on 15 or more days per month—however, for at least 1 year, instead of only 3 months, as defined in the International Headache Society (IHS) guidelines.

Exclusion Criteria:

  • headache attributable to some pathological condition, associated neurologic or neuropsychiatric disease, use of central nervous system modulating drugs, pregnancy, metallic head implants, and use of a cardiac pacemaker.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817139


Locations
Brazil
Suellen Andrade Recruiting
João Pessoa, PB, Brazil
Contact: Suellen Andrade       suellenandrade@gmail.com   
Contact       suellenandrade@gmail.com   
Sponsors and Collaborators
Federal University of Paraíba
  More Information

Responsible Party: Suellen Marinho Andrade, Professor, Federal University of Paraíba
ClinicalTrials.gov Identifier: NCT02817139     History of Changes
Other Study ID Numbers: migraine
First Submitted: June 22, 2016
First Posted: June 29, 2016
Last Update Posted: June 29, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases