Chronic MigrainePhase 3CATCHROMIGNCT02122237
Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial
A Phase 3 study testing Cefaly tDCS in people with Chronic Migraine, run by University of Liege at 1 site in Belgium.
Trial summary
Cathodal tDCS decreases the excitability of the cerebral cortex and its daily application during intercritical phase, may have a therapeutic effect in chronic migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- Cefaly tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2013to Sep 2014
- Phase
- Phase 3
- 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
- diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse
Who cannot join
- others diseases or contraindications to tDCS (epilepsy, pacemaker, metal prosthetics)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cathodal Transcranial Direct Current Stimulation in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial
Cathodal tDCS decreases the excitability of the cerebral cortex and its daily application during intercritical phase, may have a therapeutic effect in chronic migraine.
Read the detailed description
During the interictal phase, the cerebral cortex is characterised by a hyperresponsiveness to repeated sensory stimuli, manifested by a lack of habituation or adaptation of cortical responses. Lack of habituation has been shown in the visual cortex in studies of visual evoked potentials (VEP) during the interictal period and it is possibly explained by a reduction in the cortical pre-activation level due to thalamo-cortical dysrhythmia. Just before and during the migraine attack, cortical reactivity changes drastically: habituation is restored and the amplitude increases. In chronic migraine (headache occurring on 15 or more days per month for more than 3 months with features of migraine headache on at least 8 days per month), VEPs habituate normally like those recorded during attacks of episodic migraine, but have in addition an increased amplitude in the 1st block of responses. Chronic migraine was therefore compared to a "never ending migraine attack" accompanied by cortical hypersensitivity.
In this study the investigators aim to demonstrate that cathodal tDCS over the visual cortex with simultaneous anodal tDCS over the left dorsolateral prefrontal cortex is able: 1) to reduce cortical hypersensitivity and habituation as assessed by VEPs and contact heat evoked nociceptive potentials (CHEPS), as well as to decrease pain perception assessed by quantitative sensory testing (QST) and the nociceptive blink reflex (nBR); 2) to decrease headache and migraine frequency.
- Conditions
- Chronic Migraine
- Being tested
- Cefaly tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefaly tDCSDevice
Cefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular cathodal tDCS decreases it. The side effects of tDCS are minor, especially sensations of itching and scalp paresthesias.
| Study group | Role | What they receive |
|---|---|---|
| Cathodal Cefaly tDCS | Experimental | Cathodal Cefaly tDCS is delivered over the visual cortex at 2 mA of intensity, for 20 minutes, everyday for 2 months, in 14 patients. The anode is placed over the left DLPFC. Receives: Device: Cefaly tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine frequency
The investigators evaluate migraine frequency at baseline, during the treatment and 2 months after its end.
Measured: 6 months
Secondary outcomes (4)
Migraine intensity
The investigators evaluate migraine intensity at baseline, during the treatment and 2 months after its end.
Measured: 6 months
Acute medication intake
The investigators evaluate acute medication intake at baseline, during the treatment and 2 months after its end.
Measured: 6 months
Attack duration
The investigators evaluate attack duration at baseline, during the treatment and 2 months after its end.
Measured: 6 months
Scores at psychological scales
The investigators evaluate scores at psychological scales at baseline, during the treatment and 2 months after its end.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completionSep 2014
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Schoenen, University of Liege
- Investigators
- Delphine Magis, MD,PhD, Principal investigator, University of LiegeJean Schoenen, MD,PhD, Study director, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122237
- Sponsor's protocol ID
- CB-1289
- Acronym
- CATCHROMIG
- Status last verified
- May 2015
- First submitted
- 4 Nov 2013
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cathodal Transcranial Direct Current Stimulation in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial
- ClinicalTrials.gov ID
- NCT02122237
- Acronym / sponsor ID
- CATCHROMIG / CB-1289
- Conditions
- Chronic Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Apr 2014 (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.
Cathodal tDCS decreases the excitability of the cerebral cortex and its daily application during intercritical phase, may have a therapeutic effect in chronic migraine.
Detailed description
During the interictal phase, the cerebral cortex is characterised by a hyperresponsiveness to repeated sensory stimuli, manifested by a lack of habituation or adaptation of cortical responses. Lack of habituation has been shown in the visual cortex in studies of visual evoked potentials (VEP) during the interictal period and it is possibly explained by a reduction in the cortical pre-activation level due to thalamo-cortical dysrhythmia. Just before and during the migraine attack, cortical reactivity changes drastically: habituation is restored and the amplitude increases. In chronic migraine (headache occurring on 15 or more days per month for more than 3 months with features of migraine headache on at least 8 days per month), VEPs habituate normally like those recorded during attacks of episodic migraine, but have in addition an increased amplitude in the 1st block of responses. Chronic migraine was therefore compared to a "never ending migraine attack" accompanied by cortical hypersensitivity.
In this study the investigators aim to demonstrate that cathodal tDCS over the visual cortex with simultaneous anodal tDCS over the left dorsolateral prefrontal cortex is able: 1) to reduce cortical hypersensitivity and habituation as assessed by VEPs and contact heat evoked nociceptive potentials (CHEPS), as well as to decrease pain perception assessed by quantitative sensory testing (QST) and the nociceptive blink reflex (nBR); 2) to decrease headache and migraine frequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cathodal Cefaly tDCS | Experimental | Device: Cefaly tDCSCathodal Cefaly tDCS is delivered over the visual cortex at 2 mA of intensity, for 20 minutes, everyday for 2 months, in 14 patients. The anode is placed over the left DLPFC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse
Key exclusion criteria (1 listed)
- others diseases or contraindications to tDCS (epilepsy, pacemaker, metal prosthetics)
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 |
|---|---|---|
| Cefaly tDCSCefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular cathodal tDCS decreases it. The side effects of tDCS are minor, especially sensations of itching and scalp paresthesias. | Device | Cathodal Cefaly tDCS |
Primary outcome
Migraine frequency
Time frame: 6 months
The investigators evaluate migraine frequency at baseline, during the treatment and 2 months after its end.
4 secondary outcomes
Migraine intensity
Time frame: 6 months
Acute medication intake
Time frame: 6 months
Attack duration
Time frame: 6 months
Scores at psychological scales
Time frame: 6 months
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 May 2015.
Related trials for Chronic Migraine
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
RecruitingPhase 2
Study of EVO756 in Adults With Migraine
Migraine
Active, not recruiting
MMA Embolization for Refractory Chronic Migraine
Migraine Disorders
Active, not recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
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.
Delphine Magis, MD,PhD principal investigator
University of Liege
Jean Schoenen, MD,PhD study director
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cefaly tDCS in people with Chronic Migraine, run by University of Liege at 1 site in Belgium.
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: finished, as of the sponsor's last update on 28 May 2015. 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 Belgium. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 frequency (time frame: 6 months). 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 May 2015.