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

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: Completed
• Conditions: Chronic Migraine
• Intervention / Treatment: Other: tDCS

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
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine Disability Assessment - MIDAS	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

Outcome Measure	Measure Description	Time Frame
Headache Impact Test - HIT-6	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	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	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	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	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	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	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	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	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)	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	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	adverse effects assessment	"every day for up to 2 weeks"

Collaborators and Investigators

• Sponsor: Federal University of Paraíba

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Actual): February 5, 2018
• Study Completion (Actual): February 16, 2018

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 24, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Transcranial Direct Current Stimulation; Migraine Disorders; Cognitive Symptoms
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID 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