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Completed

NCT Number: NCT03414203

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

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

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Key information

Conditions

Chronic Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Paraiba

João Pessoa, Paraíba, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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)

  11. 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

  12. Side Effects Questionnaire

    Time frame: "every day for up to 2 weeks"

    adverse effects assessment

Sponsors and collaborators

Lead sponsor

Federal University of Paraíba

Other

Registry information

Official study title

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

Acronym: NEUROMIG

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2018
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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