Chronic MigraineNCT02122744
RCT Versus Placebo of rTMSQP Over Visual Cortex for the Prevention of Chronic Migraine
A study testing Super Rapid Magstim Stimulator in people with Chronic Migraine, run by University of Liege at 1 site in Belgium.
Trial summary
Evaluation of inhibiting rTMS QP over the visual cortex for the prevention of chronic migraine. The aim of the study is to confirm that inhibiting rTMS QP is capable to decrease the frequency of migraine and if its effect is stronger than placebo effect. 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?
- Super Rapid Magstim Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2013to Sep 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
- diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse.
Who cannot join
- other diseases or contraindication for the magnetic stimulation (epilepsy, pacemaker, metallic prothesis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Placebo Controlled Trial of rTMS Quadri Pulse Over Visual Cortex for the Prevention of Chronic Migraine
Evaluation of inhibiting rTMS QP over the visual cortex for the prevention of chronic migraine. The aim of the study is to confirm that inhibiting rTMS QP is capable to decrease the frequency of migraine and if its effect is stronger than placebo effect.
Read the detailed description
The investigators have already inquired if inhibiting rTMS QP over the visual cortex determines a reduction of frequency of migraine in a previous study. After 2 weekly sessions for a month, the investigators demonstrated a reduction of 47% in migraine frequency. In this study, the investigators aim to compare rTMS QP effect with the placebo effect and to evaluate if rTMS QP is capable to induce changes in VEP, CHEPS and QST.
- Conditions
- Chronic Migraine
- Being tested
- Super Rapid Magstim Stimulator, Super Rapid Magstim Stimulator (sham)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super Rapid Magstim StimulatorDevice
The repetitive transcranial magnetic stimulation (rTMS) is able to modify cortical excitability and reactivity. 1Hz rTMS inhibits the cortex, 10Hz excites it. In particular, a new paradigm of rTMS, the rTMS quadri pulse has a more lasting and effective activity.
The side effects are rare and transient: migraine,contractions of the muscles of the neck due to muscle stimulation by the electromagnetic field of the coil.
Super Rapid Magstim Stimulator (sham)Device
coil perpendicular to the scalp
| Study group | Role | What they receive |
|---|---|---|
| Super Rapid Magstim Stimulator rTMS QP | Active comparator | rTMS QP is delivered over the visual cortex for 30 minutes, 2 times a week for 8 weeks, in 15 patients Receives: Device: Super Rapid Magstim Stimulator |
| Placebo | Placebo comparator | rTMS QP placebo (coil perpendicular to the scalp) is delivered over the visual cortex for 30 minutes, 2 times a week for 8 weeks, in 15 patients. Receives: Device: Super Rapid Magstim Stimulator (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of migraine
The investigators evaluate the frequency of migraine during the treatment and 2 months after its end.
Measured: 12 months
Secondary outcomes (4)
Intensity of migraine
The investigators evaluate the intensity of migraine during the treatment and 2 months after its end
Measured: 12 months
Acute medication intake
The investigators evaluate acute medication intake during the treatment and 2 months after its end
Measured: 12 months
Attack duration
The investigators evaluate attack duration during the treatment and 2 months after its end
Measured: 12 months
Scores on psychological scales
The investigators evaluate scores on psychological scales during the treatment and 2 months after its end
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 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
- Jean Schoenen, HP, Principal investigator, University of LiegeDelphine Magis, MD,PhD, Principal investigator, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122744
- Sponsor's protocol ID
- CB-1331
- Status last verified
- Aug 2020
- First submitted
- 4 Nov 2013
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Placebo Controlled Trial of rTMS Quadri Pulse Over Visual Cortex for the Prevention of Chronic Migraine
- ClinicalTrials.gov ID
- NCT02122744
- Acronym / sponsor ID
- CB-1331
- Conditions
- Chronic Migraine
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 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
- 25 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.
Evaluation of inhibiting rTMS QP over the visual cortex for the prevention of chronic migraine. The aim of the study is to confirm that inhibiting rTMS QP is capable to decrease the frequency of migraine and if its effect is stronger than placebo effect.
Detailed description
The investigators have already inquired if inhibiting rTMS QP over the visual cortex determines a reduction of frequency of migraine in a previous study. After 2 weekly sessions for a month, the investigators demonstrated a reduction of 47% in migraine frequency. In this study, the investigators aim to compare rTMS QP effect with the placebo effect and to evaluate if rTMS QP is capable to induce changes in VEP, CHEPS and QST.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Super Rapid Magstim Stimulator rTMS QP | Active comparator | Device: Super Rapid Magstim StimulatorrTMS QP is delivered over the visual cortex for 30 minutes, 2 times a week for 8 weeks, in 15 patients |
| Placebo | Placebo comparator | Device: Super Rapid Magstim Stimulator (sham)rTMS QP placebo (coil perpendicular to the scalp) is delivered over the visual cortex for 30 minutes, 2 times a week for 8 weeks, in 15 patients. |
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)
- other diseases or contraindication for the magnetic stimulation (epilepsy, pacemaker, metallic prothesis)
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 |
|---|---|---|
| Super Rapid Magstim StimulatorThe repetitive transcranial magnetic stimulation (rTMS) is able to modify cortical excitability and reactivity. 1Hz rTMS inhibits the cortex, 10Hz excites it. In particular, a new paradigm of rTMS, the rTMS quadri pulse has a more lasting and effective activity. The side effects are rare and transient: migraine,contractions of the muscles of the neck due to muscle stimulation by the electromagnetic field of the coil. | Device | Super Rapid Magstim Stimulator rTMS QP |
| Super Rapid Magstim Stimulator (sham)coil perpendicular to the scalp | Device | Placebo |
Primary outcome
Frequency of migraine
Time frame: 12 months
The investigators evaluate the frequency of migraine during the treatment and 2 months after its end.
4 secondary outcomes
Intensity of migraine
Time frame: 12 months
Acute medication intake
Time frame: 12 months
Attack duration
Time frame: 12 months
Scores on psychological scales
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
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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.
Jean Schoenen, HP principal investigator
University of Liege
Delphine Magis, MD,PhD principal investigator
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 study testing Super Rapid Magstim Stimulator 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: withdrawn, as of the sponsor's last update on 18 Aug 2020. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Frequency of migraine (time frame: 12 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 18 Aug 2020.