Comparison Between Transcranial Stimulation Protocols With Continuous Current in the Chronic Migraine (NEUROMIG)

August 24, 2019 updated by: Renata Emanuela Lyra de Brito Aranha, Federal University of Paraíba

Comparison Between Stimulation Transcranial Protocols With Continuous Current in the Chronic Migraine: Clinical Trial, Triple-blind, Placebo-controlled

This study aims to compare the effects of transcranial direct current stimulation on the clinical and cognitive function in patients with chronic migraine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The patients will be randomized into 1 of 3 groups: active tDCS for 15 minutes, active tDCS for 15 minutes, with an interval of 20 minutes and more 15 minutes os stimulation, sham tDCS for 15 minutes. The tDCS will be applied for 10 days over 2 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraiba
      • João Pessoa, Paraiba, Brazil
        • Federal University of Paraíba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • females
  • clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta).

Exclusion Criteria:

  • headache attributable to some pathological condition, associated neurologic or neuropsychiatric disease
  • use of central nervous system modulating drugs
  • pregnancy
  • metallic head implants
  • use of a cardiac pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: active tDCS
Active tDCS for 15 minutes for 10 days over 2 weeks. Intensity: 2 milliampere. Placement: anode - left DLPFC; cathode - right supraorbital region
Other: tDCS
Transcranial Current Stimulation equipment consists of an ammeter (measured with current intensity), a potentiometer (voltage controller between the electrodes), a generator (two 9-volt batteries) and two electrodes (anode and cathode). The direct low-amplitude currents released by the electrodes reach the cortex and modify the neuronal potentials.
Experimental: active tDCS with interval
Active tDCS for 15 minutes, interval of 20 minutes and more 15 minutes for 10 days over 2 weeks. Intensity: 2 milliampere. Placement: anode - left DLPFC; cathode - right supraorbital region
Other: tDCS
Transcranial Current Stimulation equipment consists of an ammeter (measured with current intensity), a potentiometer (voltage controller between the electrodes), a generator (two 9-volt batteries) and two electrodes (anode and cathode). The direct low-amplitude currents released by the electrodes reach the cortex and modify the neuronal potentials.
Sham Comparator: sham tDCS
Sham tDCS for 15 minutes for 10 days over 2 weeks. The stimulation is non-active. Placement: anode - left DLPFC; cathode - right supraorbital region
Other: tDCS
Transcranial Current Stimulation equipment consists of an ammeter (measured with current intensity), a potentiometer (voltage controller between the electrodes), a generator (two 9-volt batteries) and two electrodes (anode and cathode). The direct low-amplitude currents released by the electrodes reach the cortex and modify the neuronal potentials.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Migraine Disability Assessment - MIDAS
Time Frame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Change in perform activities of daily living associate to migraine assessed on the Migraine Disability Assessment - MIDAS.
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Headache Impact Test - HIT-6
Time Frame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Wechsler Intelligence Scale Letters
Time Frame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale Letters
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Wechsler Intelligence Scale Numbers Test
Time Frame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale Numbers Test
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Hayling's Test Hayling's Test
Time Frame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Change in operational memory assessed on the Hayling's Test Evaluate operational memory
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Trail Making Test part B
Time Frame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Change in executive functions assessed on the Trail Making Test part B
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Salthouse Visual Patterns and Lyrics
Time Frame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Change in visual processing speed assessed on the Salthouse Visual Patterns and Lyrics
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Nine Hole Peg Test
Time Frame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Change in the motor processing speed assessed on the Nine Hole Peg Test
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Paced Auditory Serial Addition Task
Time Frame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Change in selective attention assessed on the Paced Auditory Serial Addition Task
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Concentrated Attention Test
Time Frame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Change in selective attention assessed on the Concentrated Attention Test
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Visual Attention Test (Attention Matrices)
Time Frame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Change in selective attention assessed on the Visual Attention Test (Attention Matrices)
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Montreal Cognitive Assessment
Time Frame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Change in cognition assessed on the Montreal Cognitive Assessment
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Side Effects Questionnaire
Time Frame: "every day for up to 2 weeks"
adverse effects assessment
"every day for up to 2 weeks"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Paraíba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 16, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEUROMIG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Migraine

Clinical Trials on tDCS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings