NCT03414203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2018

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

January 10, 2018

Last Update Submit

August 24, 2019

Conditions

Chronic Migraine

Keywords

Transcranial Direct Current StimulationMigraine DisordersCognitive Symptoms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Headache Impact Test - 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

    "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"

  • Wechsler 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

    "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"

  • Trail Making Test part B

    "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"

  • +7 more secondary outcomes

Study Arms (3)

active tDCS

ACTIVE COMPARATOR

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

Other: tDCS

active tDCS with interval

EXPERIMENTAL

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

sham tDCS

SHAM COMPARATOR

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

Interventions

tDCSOTHER

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.

active tDCSactive tDCS with intervalsham tDCS

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Paraiba

João Pessoa, Paraíba, Brazil

Location

MeSH Terms

Conditions

Migraine DisordersNeurobehavioral Manifestations

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Renata Aranha

    Federal University of Paraiba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 29, 2018

Study Start

August 14, 2017

Primary Completion

February 5, 2018

Study Completion

February 16, 2018

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

BR(1)