Chronic MigraineNEUROMIGNCT03414203
Comparison Between Transcranial Stimulation Protocols With Continuous Current in the Chronic Migraine
A study testing tDCS in people with Chronic Migraine, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
This study aims to compare the effects of transcranial direct current stimulation on the clinical and cognitive function in patients with chronic migraine. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Aug 2017to 16 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- females
- clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Migraine
- Being tested
- tDCS
- Keywords
- Transcranial Direct Current Stimulation, Migraine Disorders, Cognitive Symptoms
- Medical subject headings
- Migraine Disorders, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine Disability Assessment - MIDAS
Change in perform activities of daily living associate to migraine assessed on the Migraine Disability Assessment - MIDAS.
Measured: "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
Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)
Measured: "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
Measured: "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
Measured: "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
Measured: "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
Measured: "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
Measured: "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
Measured: "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
Measured: "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
Measured: "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)
Measured: "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
Measured: "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
Measured: "every day for up to 2 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start14 Aug 2017
- Primary completion5 Feb 2018
- Study completion16 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renata Emanuela Lyra de Brito Aranha, Federal University of Paraíba
- Investigators
- Renata Aranha, Principal investigator, Federal University of Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414203
- Sponsor's protocol ID
- NEUROMIG
- Acronym
- NEUROMIG
- Status last verified
- Aug 2019
- First submitted
- 10 Jan 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Stimulation Transcranial Protocols With Continuous Current in the Chronic Migraine: Clinical Trial, Triple-blind, Placebo-controlled
- ClinicalTrials.gov ID
- NCT03414203
- Acronym / sponsor ID
- NEUROMIG / NEUROMIG
- Conditions
- Chronic Migraine
- Keywords
- Transcranial Direct Current Stimulation, Migraine Disorders, Cognitive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 5 Feb 2018 (actual)
- Study completion
- 16 Feb 2018 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Active comparator | Other: tDCSActive tDCS for 15 minutes for 10 days over 2 weeks. Intensity: 2 milliampere. Placement: anode - left DLPFC; cathode - right supraorbital region |
| active tDCS with interval | Experimental | Other: tDCSActive 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 | Sham comparator | Other: tDCSSham tDCS for 15 minutes for 10 days over 2 weeks. The stimulation is non-active. Placement: anode - left DLPFC; cathode - right supraorbital region |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- females
- clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSTranscranial 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. | Other | active tDCS, active tDCS with interval, sham tDCS |
Primary outcome
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.
12 secondary outcomes
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"
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"
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"
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"
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"
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"
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"
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"
Concentrated Attention Test
Time frame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
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"
Montreal Cognitive Assessment
Time frame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Side Effects Questionnaire
Time frame: "every day for up to 2 weeks"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Related trials for Chronic Migraine
Not yet recruiting
Laser Acupuncture for Chronic Migraine: Clinical Response, Traditional Chinese Medicine Syndrome Patterns, and Brain Function
Chronic Migraine Headache
Active, not recruitingPhase 3
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Migraine
RecruitingEarly Phase 1
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
Persistent Postural Perceptual Dizziness, Vestibular Migraine
RecruitingObservational study
Overlapping Pain Trajectory Study
Migraine, Musculoskeletal Pain
Not yet recruitingObservational study
Psychological Support for Chronic Migraine Patients Treated With Anti-CGRP (Anti-Calcitonin Gene-Related Peptide ) Monoclonal Antibodies
Chronic Migraine Headache, Psychologic Adaptation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renata Aranha principal investigator
Federal University of Paraiba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Chronic Migraine, run by Federal University of Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.