Episodic MigraineNCT04031781
The Role of Left Prefrontal Transcranial Magnetic Stimulation in Episodic Migraine Prophylaxis
A study testing repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold and repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold in people with Episodic Migraine and Prophylaxis, run by Ain Shams University.
Trial summary
The aim of the study was to examine the prophylactic role of repetitive transcranial magnetic stimulation (rTMS) on the frequency, and severity of migraine attacks in episodic migraineurs who failed medical treatment. A group received 5 rTMS sessions, delivered over one week. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Episodic Migraine, Prophylaxis
- What is being tested?
- repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold and repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 1 Feb 2015
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- cases diagnosed as episodic migraine with or without aura according to the ICHD 3rd edition
- With a headache frequency of 4-14 per month for the last six months
- Patients who had either an unsatisfactory response, declined or were intolerant to at least two prophylactic medications.
Who cannot join
- Patients with past family history of seizures
- Other chronic pain disorders
- Severe depression (Beck Depression Inventory of 30 or more)
- Other significant neurologic or psychiatric diagnosis including substance misuse
- Metal implants in the head
- Pregnant or breastfeeding ladies
- Prior experience with TMS
About this study
The aim of the study was to examine the prophylactic role of repetitive transcranial magnetic stimulation (rTMS) on the frequency, and severity of migraine attacks in episodic migraineurs who failed medical treatment.
A group received 5 rTMS sessions, delivered over one week. Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration given at 5-Hz frequency and 100% motor threshold intensity and the placebo group received rTMS with the same stimulation frequency at a fixed intensity of 50% of the machine output
- Conditions
- Episodic Migraine, Prophylaxis
- Being tested
- repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold, repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold
- Keywords
- rTMS = repetitive transcranial magnetic stimulation, LDLPFC = Left dorsolateral prefrontal cortex, HIT 6 = Headache Impact test, NPRS = Numeric Pain Rating Scale, ICHD = The international classfication of Headache disorder, MT= Motor threshold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation (rTMS) 100% motor thresholdDevice
Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration.
repetitive transcranial magnetic stimulation (rTMS) 50% motor thresholdDevice
Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration.
| Study group | Role | What they receive |
|---|---|---|
| Receiving repetitive transcranial magnetic stimulation (rTMS) | Active comparator | This group received 5 rTMS sessions, delivered over one week over the left dorsolateral prefrontal cortex (LDLPFC ) at 5-Hz frequency and 100% motor threshold intensity. Receives: Device: repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold |
| Group receiving placebo rTMS | Placebo comparator | This group received Placebo rTMS was given with the same stimulation frequency at a fixed intensity of 50% of the machine output Receives: Device: repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine attack frequency
The primary outcome measure was defined as the reduction of number of migraine attacks by at least 50% after rTMS sessions.
Measured: 2 months
Secondary outcomes (4)
Migraine days
Number of days that the migraine attack lasts in
Measured: 2 months
Migraine attack severity
The intensity of pain that was assessed using the zero to ten Numeric Pain Rating Scale (NPRS)
Measured: 2 months
Functional disability
Functional disability was measured using the HIT-6 score. Severe HIT-6 was defined as a score of 60 or more. A clinically significant change in the HIT-6 was defined as a change of five points or more.
Measured: 2 months
Use of abortive pills
Number of pills used per month
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start1 May 2013
- Primary completion20 Aug 2014
- Study completion1 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episodic MigraineStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Emara, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031781
- Sponsor's protocol ID
- FMASU 1171/2012
- Status last verified
- Jul 2019
- First submitted
- 20 Jul 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Left Prefrontal Transcranial Magnetic Stimulation in Episodic Migraine Prophylaxis
- ClinicalTrials.gov ID
- NCT04031781
- Acronym / sponsor ID
- FMASU 1171/2012
- Conditions
- Episodic Migraine, Prophylaxis
- Keywords
- rTMS = repetitive transcranial magnetic stimulation, LDLPFC = Left dorsolateral prefrontal cortex, HIT 6 = Headache Impact test, NPRS = Numeric Pain Rating Scale, ICHD = The international classfication of Headache disorder, MT= Motor threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 20 Aug 2014 (actual)
- Study completion
- 1 Feb 2015 (actual)
- First posted
- 24 Jul 2019 (actual)
- 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 aim of the study was to examine the prophylactic role of repetitive transcranial magnetic stimulation (rTMS) on the frequency, and severity of migraine attacks in episodic migraineurs who failed medical treatment.
A group received 5 rTMS sessions, delivered over one week. Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration given at 5-Hz frequency and 100% motor threshold intensity and the placebo group received rTMS with the same stimulation frequency at a fixed intensity of 50% of the machine output
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receiving repetitive transcranial magnetic stimulation (rTMS) | Active comparator | Device: repetitive transcranial magnetic stimulation (rTMS) 100% motor thresholdThis group received 5 rTMS sessions, delivered over one week over the left dorsolateral prefrontal cortex (LDLPFC ) at 5-Hz frequency and 100% motor threshold intensity. |
| Group receiving placebo rTMS | Placebo comparator | Device: repetitive transcranial magnetic stimulation (rTMS) 50% motor thresholdThis group received Placebo rTMS was given with the same stimulation frequency at a fixed intensity of 50% of the machine output |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- cases diagnosed as episodic migraine with or without aura according to the ICHD 3rd edition
- With a headache frequency of 4-14 per month for the last six months
- Patients who had either an unsatisfactory response, declined or were intolerant to at least two prophylactic medications.
Key exclusion criteria (7 listed)
- Patients with past family history of seizures
- Other chronic pain disorders
- Severe depression (Beck Depression Inventory of 30 or more)
- Other significant neurologic or psychiatric diagnosis including substance misuse
- Metal implants in the head
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 |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS) 100% motor thresholdEach rTMS session consisted of a single train of 900 total pulses over 3 minutes duration. | Device | Receiving repetitive transcranial magnetic stimulation (rTMS) |
| repetitive transcranial magnetic stimulation (rTMS) 50% motor thresholdEach rTMS session consisted of a single train of 900 total pulses over 3 minutes duration. | Device | Group receiving placebo rTMS |
Primary outcome
Migraine attack frequency
Time frame: 2 months
The primary outcome measure was defined as the reduction of number of migraine attacks by at least 50% after rTMS sessions.
4 secondary outcomes
Migraine days
Time frame: 2 months
Migraine attack severity
Time frame: 2 months
Functional disability
Time frame: 2 months
Use of abortive pills
Time frame: 2 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 24 Jul 2019.
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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 repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold and repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold in people with Episodic Migraine and Prophylaxis, run by Ain Shams University.
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 3 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: finished, as of the sponsor's last update on 24 Jul 2019. 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?
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 attack frequency (time frame: 2 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 24 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.