MigrainePhase 2NCT01886274
Does tDCS is Effective in the Prophylactic Treatment of Migraine
A Phase 2 study testing Transcranial direct current stimulation in people with Migraine, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Migraine has been described as one of the most common neurological diseases, with high social and economic impact. Despite the high prevalence, the pathophysiology of migraine is still unknown, several studies have been developed in order to advance the understanding of the pathophysiological mechanisms of the disease… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2012to Oct 2014
- Phase
- Phase 2
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age must be between 18 to 40 years
- Gender: male and female
- Diagnosis must meet the 2004 IHS criteria for migraine without aura and migraine with aura
- Duration of the disease must be at least 12 months
- Patients had no preventative medication consistently for at least six months prior to study initiation.
- Age must be between 18 to 40 years
- Gender: male and female
- Individuals who have not filed headache crisis in the last year assessed according to the 2004 IHS criteria
Who cannot join
- Pregnant woman
- Individuals with clinical evidence of brain injury
- Metallic implant head
- Pacemaker
- History of seizure and chronic pain associated with other pathologies
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Applied Neuroscience Laboratory-LANA
Recife, Pernambuco, 50740-560
Kátia Karina Monte-Silva, Dr
About this study
Official title: Transcranial Direct Current Stimulation in the Visual Cortex of Migraine Patients: Neurophysiological and Clinical Implications
Migraine has been described as one of the most common neurological diseases, with high social and economic impact. Despite the high prevalence, the pathophysiology of migraine is still unknown, several studies have been developed in order to advance the understanding of the pathophysiological mechanisms of the disease which are not yet entirely elucidated. The aim of this study is to observe the effects of transcranial direct current stimulation (tDCS), applied in the visual cortex, on neurophysiological and clinical measures (frequency, intensity, duration of attacks and severity of pain) in migraine patients.
- Conditions
- Migraine
- Being tested
- Transcranial direct current stimulation
- Keywords
- EEG, migraine, pain, phosphene, tDCs, TMS
- Medical subject headings
- Migraine Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The cathodal tDCS decrease the excitability, in this study a constant current of 2 mA intensity was applied for 20 min.
| Study group | Role | What they receive |
|---|---|---|
| tDCS | Experimental | The experimental group received tDCS to the occipital cortex in 12 sessions, 3 days per week. Receives: Device: Transcranial direct current stimulation |
| control | Sham comparator | The control group received sham stimulation to the occipital cortex in 12 sessions, 3 days per week. Receives: Device: Transcranial direct current stimulation |
| healthy subjects | No intervention | This group was submitted to one evaluation session of cortical excitability. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from phosphene threshold
A 10-cm circular coil was used that has giving a peak magnetic field strength of 2 tesla. Subjects were asked to wear a blindfold, sit comfortably in a chair and to close their eyes to diminish ambient light.In sagittal line, three points were scored: 2, 3 and 4 cm above the inion. The single pulse transcranial magnetic stimulation was applied to one of the points scored and the subject was asked to report the presence or absence of a phosphene immediately after stimulation. The stimulation was repeated ten times at each intensity with a maximum frequency of 0.2 Hz, stimulation was initially applied to 60% of the maximum intensity of the stimulator. The intensity of stimulation was changed into blocks of 5% to minimum intensity that the subject can perceive the phosphene certainly, five times ten, then this value was set as the PT for migraineurs and controls.
Measured: At baseline,1 month, 2 months, 3 months/ per session - at baseline and 30 minutes (after tDCS)
Secondary outcomes (2)
Change from eletroencephalography
Electroencephalography was performed by digital EEG equipment, the sampling rate of 500 Hz, 0.5 Hz high pass filter and low pass 35 Hz to capture brain electrical activity through 23 electrodes on the scalp according to the International 10-20 system.After positioning the electrodes, the subject remained comfortably seated and relaxed, but awake, with eyes closed 30 cm from the photic stimulator and, without any stimulation, EEG was collected for 1 minute (baseline).After the baseline, was collected a sequence of 1 minute record without stimulation followed by 3 seconds to 9 Hz photic stimulation. This sequence is repeated 4 times. After this procedure, the subject received trains of visual stimuli, 20 seconds each, at frequencies of 3, 9, 15, 21 and 27 Hz, 1 minute spaced from each other and totaling 12 minutes evaluation.
Measured: At baseline, 1 month and 2 months, 3 months
Change from pain diary
The diary is a report of the frequency of the migraine attacks, the intensity, the onset and duration of the pain, the number of migraine-related days (the number of days on which the patients had migraine-related symptoms) and the type of analgesics in case of a migraine attack;
Measured: 3 followed months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2013
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886274
- Sponsor's protocol ID
- Migraine_tDCS
- Status last verified
- May 2014
- First submitted
- 18 Jun 2013
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation in the Visual Cortex of Migraine Patients: Neurophysiological and Clinical Implications
- ClinicalTrials.gov ID
- NCT01886274
- Acronym / sponsor ID
- Migraine_tDCS
- Conditions
- Migraine
- Keywords
- EEG, migraine, pain, phosphene, tDCs, TMS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2014 (estimated)
- First posted
- 25 Jun 2013 (estimated)
- 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.
Migraine has been described as one of the most common neurological diseases, with high social and economic impact. Despite the high prevalence, the pathophysiology of migraine is still unknown, several studies have been developed in order to advance the understanding of the pathophysiological mechanisms of the disease which are not yet entirely elucidated. The aim of this study is to observe the effects of transcranial direct current stimulation (tDCS), applied in the visual cortex, on neurophysiological and clinical measures (frequency, intensity, duration of attacks and severity of pain) in migraine patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS | Experimental | Device: Transcranial direct current stimulationThe experimental group received tDCS to the occipital cortex in 12 sessions, 3 days per week. |
| control | Sham comparator | Device: Transcranial direct current stimulationThe control group received sham stimulation to the occipital cortex in 12 sessions, 3 days per week. |
| healthy subjects | No intervention | –This group was submitted to one evaluation session of cortical excitability. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age must be between 18 to 40 years
- Gender: male and female
- Diagnosis must meet the 2004 IHS criteria for migraine without aura and migraine with aura
- Duration of the disease must be at least 12 months
- Patients had no preventative medication consistently for at least six months prior to study initiation.
Key exclusion criteria (5 listed)
- Pregnant woman
- Individuals with clinical evidence of brain injury
- Metallic implant head
- Pacemaker
- History of seizure and chronic pain associated with other pathologies
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 |
|---|---|---|
| Transcranial direct current stimulationtDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The cathodal tDCS decrease the excitability, in this study a constant current of 2 mA intensity was applied for 20 min. | Device | control, tDCS |
Primary outcome
Change from phosphene threshold
Time frame: At baseline,1 month, 2 months, 3 months/ per session - at baseline and 30 minutes (after tDCS)
A 10-cm circular coil was used that has giving a peak magnetic field strength of 2 tesla. Subjects were asked to wear a blindfold, sit comfortably in a chair and to close their eyes to diminish ambient light.In sagittal line, three points were scored: 2, 3 and 4 cm above the inion. The single pulse transcranial magnetic stimulation was applied to one of the points scored and the subject was asked to report the presence or absence of a phosphene immediately after stimulation. The stimulation was repeated ten times at each intensity with a maximum frequency of 0.2 Hz, stimulation was initially applied to 60% of the maximum intensity of the stimulator. The intensity of stimulation was changed into blocks of 5% to minimum intensity that the subject can perceive the phosphene certainly, five times ten, then this value was set as the PT for migraineurs and controls.
2 secondary outcomes
Change from eletroencephalography
Time frame: At baseline, 1 month and 2 months, 3 months
Change from pain diary
Time frame: 3 followed months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transcranial direct current stimulation in people with Migraine, run by Universidade Federal de Pernambuco 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 8 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: status not confirmed, as of the sponsor's last update on 20 May 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kátia Karina Monte-Silva, Dr (21267579, monte.silvakk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from phosphene threshold (time frame: At baseline,1 month, 2 months, 3 months/ per session - at baseline and 30 minutes (after tDCS)). 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 20 May 2014; AzTrials last refreshed its copy on 7 Nov 2026.