Migraine DisordersPhase 1/2NCT02817139
Transcranial Direct Current Simulation in Chronic Migraine
A Phase 1/2 study testing TDCS in people with Migraine Disorders, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
This study is a pilot, double-blind, placebo-controlled, randomized trial aiming to compare the effects of transcranial direct current stimulation in Chronic Migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- TDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2016to Sep 2016
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with a clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta) of the International Headache Society, with an established headache history occurring on 15 or more days per month-however, for at least 1 year, instead of only 3 months, as defined in the International Headache Society (IHS) guidelines.
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, and use of a cardiac pacemaker.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Suellen Andrade
João Pessoa, Paraíba
Suellen Andrade, suellenandrade@gmail.com
suellenandrade@gmail.com
About this study
Official title: Transcranial Direct Current Simulation Over Primary Motor vs Prefrontal Cortex in Chronic Migraine: a Pilot Randomized Controlled Trial
This study is a pilot, double-blind, placebo-controlled, randomized trial aiming to compare the effects of transcranial direct current stimulation in Chronic Migraine.
Read the detailed description
The patients will be randomized into 1 of 3 groups: active tDCS over primary motor cortex, active tDCS over prefrontal cortex, sham tDCS. Each group will receive treatment for 20 minutes a day, 3 days a week for 4 weeks.
- Conditions
- Migraine Disorders
- Being tested
- TDCS
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDCSDevice
Also called Transcranial Direct Current Stimulation
| Study group | Role | What they receive |
|---|---|---|
| active tDCS over primary motor cortex | Active comparator | Duration: 20 minutes; Intensity: 2 mA; Placement: left primary motor cortex. Receives: Device: TDCS |
| active tDCS over prefrontal cortex | Experimental | Duration: 20 minutes; Intensity: 2 mA; Placement: left prefrontal cortex. Receives: Device: TDCS |
| sham tDCS over primary motor cortex | Placebo comparator | Duration: 20 minutes; The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham; Placement: left primary motor cortex. Receives: Device: TDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)
Measured: Baseline (week 1) and Endpoint (week 4)
Secondary outcomes (3)
Change in pain assessed on the Visual Analogue Scale (VAS)
Measured: Baseline (week 1) and Endpoint (week 4)
Change in quality of life assessed on the Medical Outcomes Study 36 - Item Short - Form Health Survey(SF-36)
Measured: Baseline (week 1) and and Endpoint (week 4)
Side Effects Questionnaire
Measured: From date of first neurostimulation until the date of last neurostimulation, , assessed up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2016
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suellen Marinho Andrade, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817139
- Sponsor's protocol ID
- migraine
- Status last verified
- Jun 2016
- First submitted
- 22 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Simulation Over Primary Motor vs Prefrontal Cortex in Chronic Migraine: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02817139
- Acronym / sponsor ID
- migraine
- Conditions
- Migraine Disorders
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (estimated)
- First posted
- 29 Jun 2016 (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.
This study is a pilot, double-blind, placebo-controlled, randomized trial aiming to compare the effects of transcranial direct current stimulation in Chronic Migraine.
Detailed description
The patients will be randomized into 1 of 3 groups: active tDCS over primary motor cortex, active tDCS over prefrontal cortex, sham tDCS. Each group will receive treatment for 20 minutes a day, 3 days a week for 4 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
| Arm | Type | Receives |
|---|---|---|
| active tDCS over primary motor cortex | Active comparator | Device: TDCSDuration: 20 minutes; Intensity: 2 mA; Placement: left primary motor cortex. |
| active tDCS over prefrontal cortex | Experimental | Device: TDCSDuration: 20 minutes; Intensity: 2 mA; Placement: left prefrontal cortex. |
| sham tDCS over primary motor cortex | Placebo comparator | Device: TDCSDuration: 20 minutes; The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham; Placement: left primary motor cortex. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with a clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta) of the International Headache Society, with an established headache history occurring on 15 or more days per month-however, for at least 1 year, instead of only 3 months, as defined in the International Headache Society (IHS) guidelines.
Key exclusion criteria (1 listed)
- headache attributable to some pathological condition, associated neurologic or neuropsychiatric disease, use of central nervous system modulating drugs, pregnancy, metallic head implants, and 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 |
|---|---|---|
| TDCSAlso: Transcranial Direct Current Stimulation | Device | active tDCS over prefrontal cortex, active tDCS over primary motor cortex, sham tDCS over primary motor cortex |
Primary outcome
Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)
Time frame: Baseline (week 1) and Endpoint (week 4)
3 secondary outcomes
Change in pain assessed on the Visual Analogue Scale (VAS)
Time frame: Baseline (week 1) and Endpoint (week 4)
Change in quality of life assessed on the Medical Outcomes Study 36 - Item Short - Form Health Survey(SF-36)
Time frame: Baseline (week 1) and and Endpoint (week 4)
Side Effects Questionnaire
Time frame: From date of first neurostimulation until the date of last neurostimulation, , assessed up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
Related trials for Migraine Disorders
Active, not recruitingObservational study
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Migraine
Active, not recruitingObservational study
Consistency of Response With Rimegepant in Acute Treatment of Migraine
Migraine
RecruitingObservational study
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
Migraine
RecruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
Post Traumatic Headache
Active, not recruiting
Cocoa Extract for Migraine Trial
Migraine
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 1/2 study testing TDCS in people with Migraine Disorders, 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 1 inclusion and 1 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 29 Jun 2016. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6) (time frame: Baseline (week 1) and Endpoint (week 4)). 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 29 Jun 2016.