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

Primary Purpose

Chronic Migraine

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
tDCS
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Migraine focused on measuring Transcranial Direct Current Stimulation, Migraine Disorders, Cognitive Symptoms

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Paraiba

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Sham Comparator

Arm Label

active tDCS

active tDCS with interval

sham tDCS

Arm Description

Active tDCS for 15 minutes for 10 days over 2 weeks. Intensity: 2 milliampere. Placement: anode - left DLPFC; cathode - right supraorbital region

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

Sham tDCS for 15 minutes for 10 days over 2 weeks. The stimulation is non-active. Placement: anode - left DLPFC; cathode - right supraorbital region

Outcomes

Primary Outcome Measures

Migraine Disability Assessment - MIDAS
Change in perform activities of daily living associate to migraine assessed on the Migraine Disability Assessment - MIDAS.

Secondary Outcome Measures

Headache Impact Test - HIT-6
Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)
Wechsler Intelligence Scale Letters
Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale Letters
Wechsler Intelligence Scale Numbers Test
Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale Numbers Test
Hayling's Test Hayling's Test
Change in operational memory assessed on the Hayling's Test Evaluate operational memory
Trail Making Test part B
Change in executive functions assessed on the Trail Making Test part B
Salthouse Visual Patterns and Lyrics
Change in visual processing speed assessed on the Salthouse Visual Patterns and Lyrics
Nine Hole Peg Test
Change in the motor processing speed assessed on the Nine Hole Peg Test
Paced Auditory Serial Addition Task
Change in selective attention assessed on the Paced Auditory Serial Addition Task
Concentrated Attention Test
Change in selective attention assessed on the Concentrated Attention Test
Visual Attention Test (Attention Matrices)
Change in selective attention assessed on the Visual Attention Test (Attention Matrices)
Montreal Cognitive Assessment
Change in cognition assessed on the Montreal Cognitive Assessment
Side Effects Questionnaire
adverse effects assessment

Full Information

First Posted
January 10, 2018
Last Updated
August 24, 2019
Sponsor
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT03414203
Brief Title
Comparison Between Transcranial Stimulation Protocols With Continuous Current in the Chronic Migraine
Acronym
NEUROMIG
Official Title
Comparison Between Stimulation Transcranial Protocols With Continuous Current in the Chronic Migraine: Clinical Trial, Triple-blind, Placebo-controlled
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
February 5, 2018 (Actual)
Study Completion Date
February 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine
Keywords
Transcranial Direct Current Stimulation, Migraine Disorders, Cognitive Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients will be randomized into 1 of 3 groups: group A: active tDCS for 15 minutes, group B: active tDCS for 15 minutes, with an interval of 20 minutes and group C: more 15 minutes os stimulation, sham tDCS for 15 minutes.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active tDCS
Arm Type
Active Comparator
Arm Description
Active tDCS for 15 minutes for 10 days over 2 weeks. Intensity: 2 milliampere. Placement: anode - left DLPFC; cathode - right supraorbital region
Arm Title
active tDCS with interval
Arm Type
Experimental
Arm Description
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
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
Sham tDCS for 15 minutes for 10 days over 2 weeks. The stimulation is non-active. Placement: anode - left DLPFC; cathode - right supraorbital region
Intervention Type
Other
Intervention Name(s)
tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Migraine Disability Assessment - MIDAS
Description
Change in perform activities of daily living associate to migraine assessed on the 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"
Secondary Outcome Measure Information:
Title
Headache Impact Test - HIT-6
Description
Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)
Time Frame
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Title
Wechsler Intelligence Scale Letters
Description
Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale Letters
Time Frame
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Title
Wechsler Intelligence Scale Numbers Test
Description
Change in cognitive ability assessed on the Wechsler Adult 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"
Title
Hayling's Test Hayling's Test
Description
Change in operational memory assessed on the Hayling's Test Evaluate operational memory
Time Frame
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Title
Trail Making Test part B
Description
Change in executive functions assessed on the 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"
Title
Salthouse Visual Patterns and Lyrics
Description
Change in visual processing speed assessed on the 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"
Title
Nine Hole Peg Test
Description
Change in the motor processing speed assessed on the 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"
Title
Paced Auditory Serial Addition Task
Description
Change in selective attention assessed on the 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"
Title
Concentrated Attention Test
Description
Change in selective attention assessed on the Concentrated Attention Test
Time Frame
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Title
Visual Attention Test (Attention Matrices)
Description
Change in selective attention assessed on the 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"
Title
Montreal Cognitive Assessment
Description
Change in cognition assessed on the Montreal Cognitive Assessment
Time Frame
"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Title
Side Effects Questionnaire
Description
adverse effects assessment
Time Frame
"every day for up to 2 weeks"

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata Aranha
Organizational Affiliation
Federal University of Paraiba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Paraiba
City
João Pessoa
State/Province
Paraiba
Country
Brazil

12. IPD Sharing Statement

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

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