Chronic MigraineNCT01752439
Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache
A study testing Anodal transcranial direct current stimulation in people with Chronic Migraine and Medication Overuse Headache, run by Dr Armando Perrotta, MD, PhD.
Trial summary
The purpose of the study is to evaluate the efficacy of the transcranial direct current stimulation of the primary motor cortex (M1) in patients affected by refractory chronic migraine (coded as 1.5.1 in the international headache classification 2nd edition, 2004) and medication-overuse headache (coded as 8.1) with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine, Medication Overuse Headache
- What is being tested?
- Anodal transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Mar 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic MIgraine or Medication Overuse Headache according to the diagnostic criteria set out in the 2nd edition of the International Classification of Headache Disorders refractory to treatment according to the Refractory Headache Special Interest Section of the American Headache Society (Schulman et al., 2008)
Who cannot join
- Other primary or secondary headaches.
- Any serious systemic or neurological disease or psychiatric disorder.
- Pregnancy or breastfeeding
- Previous or current use of other or similar devices for pain control
- Heart conduction and rhythm disorders
- Cranial surgery
- Other pain conditions, accordingly with current guidelines
About this study
Official title: Randomized Double-Blind Sham-Controlled Study of the Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache Patients
The purpose of the study is to evaluate the efficacy of the transcranial direct current stimulation of the primary motor cortex (M1) in patients affected by refractory chronic migraine (coded as 1.5.1 in the international headache classification 2nd edition, 2004) and medication-overuse headache (coded as 8.1) with migraine as primary headache.
- Conditions
- Chronic Migraine, Medication Overuse Headache
- Being tested
- Anodal transcranial direct current stimulation, Sham transcranial direct current stimulation
- Keywords
- Chronic Migraine, Medication Overuse Headache, Refractory, transcranial direct current stimulation
- Medical subject headings
- Headache Disorders, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal transcranial direct current stimulationDevice
Also called Transcranial direct current stimulator HDCstim, Newronika s.r.l., Milan, Italy
Sham transcranial direct current stimulationDevice
Also called Transcranial direct current stimulator HDCstim, Newronika s.r.l., Milan, Italy
| Study group | Role | What they receive |
|---|---|---|
| Anodal transcranial direct current stimulation | Experimental | Anodal transcranial direct current stimulation Receives: Device: Anodal transcranial direct current stimulation |
| Sham transcranial direct current stimulation | Sham comparator | Sham transcranial direct current stimulation Receives: Device: Sham transcranial direct current stimulation |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in headache days per months
Measured: at 30, 60 and 90 days after the treatment
Change in drugs intake per months
Measured: at 30, 60 and 90 days after treatment
Secondary outcomes (1)
Change in mean pain intensity score per months
Measured: at 30, 60 and 90 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionDec 2013 (estimated)
- Study completionMar 2014 (estimated)
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Armando Perrotta, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Armando Perrotta, MD, PhD, Mediterranean Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752439
- Sponsor's protocol ID
- tDCSCMMOH1
- Status last verified
- Dec 2012
- First submitted
- 11 Dec 2012
- Last updated
- 19 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Sham-Controlled Study of the Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache Patients
- ClinicalTrials.gov ID
- NCT01752439
- Acronym / sponsor ID
- tDCSCMMOH1
- Conditions
- Chronic Migraine, Medication Overuse Headache
- Keywords
- Chronic Migraine, Medication Overuse Headache, Refractory, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dr Armando Perrotta, MD, PhDUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 19 Dec 2012 (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.
The purpose of the study is to evaluate the efficacy of the transcranial direct current stimulation of the primary motor cortex (M1) in patients affected by refractory chronic migraine (coded as 1.5.1 in the international headache classification 2nd edition, 2004) and medication-overuse headache (coded as 8.1) with migraine as primary headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal transcranial direct current stimulation | Experimental | Device: Anodal transcranial direct current stimulationAnodal transcranial direct current stimulation |
| Sham transcranial direct current stimulation | Sham comparator | Device: Sham transcranial direct current stimulationSham transcranial direct current stimulation |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic MIgraine or Medication Overuse Headache according to the diagnostic criteria set out in the 2nd edition of the International Classification of Headache Disorders refractory to treatment according to the Refractory Headache Special Interest Section of the American Headache Society (Schulman et al., 2008)
Key exclusion criteria (7 listed)
- Other primary or secondary headaches.
- Any serious systemic or neurological disease or psychiatric disorder.
- Pregnancy or breastfeeding
- Previous or current use of other or similar devices for pain control
- Heart conduction and rhythm disorders
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 |
|---|---|---|
| Anodal transcranial direct current stimulationAlso: Transcranial direct current stimulator HDCstim, Newronika s.r.l., Milan, Italy | Device | Anodal transcranial direct current stimulation |
| Sham transcranial direct current stimulationAlso: Transcranial direct current stimulator HDCstim, Newronika s.r.l., Milan, Italy | Device | Sham transcranial direct current stimulation |
Primary outcome
Change in headache days per months
Time frame: at 30, 60 and 90 days after the treatment
Change in drugs intake per months
Time frame: at 30, 60 and 90 days after treatment
1 secondary outcome
Change in mean pain intensity score per months
Time frame: at 30, 60 and 90 days after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal transcranial direct current stimulation in people with Chronic Migraine and Medication Overuse Headache, run by Dr Armando Perrotta, MD, PhD.
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 7 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 19 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Change in headache days per months (time frame: at 30, 60 and 90 days after the treatment). The study lists 2 primary outcomes in all. 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 19 Dec 2012.