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

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ClinicalTrials.gov Identifier: NCT03414203
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Renata Emanuela Lyra de Brito Aranha, Federal University of Paraíba

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.

Condition or disease Intervention/treatment Phase
Chronic Migraine Other: tDCS Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Stimulation Transcranial Protocols With Continuous Current in the Chronic Migraine: Clinical Trial, Triple-blind, Placebo-controlled
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : February 5, 2018
Estimated Study Completion Date : April 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT03414203


Contacts
Contact: Renata Aranha (83) 988128339 renataemanuelalb@gmail.com

Locations
Brazil
Federal University of Paraiba Recruiting
João Pessoa, Paraiba, Brazil
Contact: Renata Aranha       renataemanuelalb@gmail.com   
Sponsors and Collaborators
Federal University of Paraíba
Investigators
Principal Investigator: Renata Aranha Federal University of Paraiba

Responsible Party: Renata Emanuela Lyra de Brito Aranha, researcher, Federal University of Paraíba
ClinicalTrials.gov Identifier: NCT03414203     History of Changes
Other Study ID Numbers: NEUROMIG
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

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

Keywords provided by Renata Emanuela Lyra de Brito Aranha, Federal University of Paraíba:
Transcranial Direct Current Stimulation
Migraine Disorders
Cognitive Symptoms

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