Chronic MigrainerTMSNCT06461767
Repetitive Transcranial Magnetic Stimulation in Treatment and Prophylaxis of Chronic Migraine in Patients With no Prophylactic Treatment for the Last 3 Months
A study testing transcranial magnetic stimulation device in people with Chronic Migraine, run by Sohag University at 1 site in Egypt.
Trial summary
Compared with the patients with episodic migraine those with chronic migraine have worst quality of life and more severe headache related disability we investigate Repetitive transcranial magnetic stimulation in treatment and prophylaxis of chronic migraine Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- transcranial magnetic stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Jan 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A study sample of patients with chronic migraine according to international classification of headache disorders-3 (ICHD-3).
- Patients are regular on follow up visits.
Who cannot join
- Patients with depression by Hamiliton scale of depression by using its Arabic version Translated by Dr Lotfy Fateem
- patients on prophylactic medications for chronic migraine.
- pregnancy.
- cochlear implants, cardiac pacemaker, and metal body implanted in head-and-neck region.
- Patients refused to give informed consent.
- History of seizures.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag faculty of medicine
Sohag, 02
Tarek Mohamed, 01025545002, tarikmohamed@med.sohag.edu.eg
About this study
Official title: Repetitive Transcranial Magnetic Stimulation in Treatment of Chronic Migraine
Compared with the patients with episodic migraine those with chronic migraine have worst quality of life and more severe headache related disability we investigate Repetitive transcranial magnetic stimulation in treatment and prophylaxis of chronic migraine
- Conditions
- Chronic Migraine
- Being tested
- transcranial magnetic stimulation device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulation deviceDevice
Repetitive transcranial magnetic stimulation parameters:
stimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30
| Study group | Role | What they receive |
|---|---|---|
| group (1) will rTMS over left motor cortex | Active comparator | Repetitive transcranial magnetic stimulation parameters:
stimulation site: left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40 Receives: Device: transcranial magnetic stimulation device |
| group (2) will receive rTMS over left dorsolateral prefrontal cortex | Active comparator | Repetitive transcranial magnetic stimulation parameters:
stimulation site: left dorsolateral prefrontal cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40 Receives: Device: transcranial magnetic stimulation device |
| group (3) will receive rTMS over left dorsolateral prefrontal cortex and left motor cortex | Active comparator | Repetitive transcranial magnetic stimulation parameters:
stimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40 Receives: Device: transcranial magnetic stimulation device |
| group (4) will receive sham stimulation | Sham comparator | Repetitive transcranial magnetic stimulation parameters:
stimulation site: the coil will be perpendicular over vertex of skull intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40 Receives: Device: transcranial magnetic stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of headache severity and number of attacks of headache before and after intervention by visual analogue scale and headache impact test
improvement of headache severity and number of attacks of headache before and after intervention by visual analogue scale and headache impact test
Measured: one month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (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.
- More trials run by Sohag 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- the patient will divide into 4 groups first group will receive stimulation over the left motor cortex second group will receive stimulation over left dorsolateral prefrontal cortex third group will receive stimulation over both left motor cortex and left dorsolateral prefrontal cortex fourth group will receive sham stimulation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarik Mohamed Abdelnaeem, Sohag University
- Investigators
- Tarek Mohamed, Principal investigator, Sohag faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461767
- Sponsor's protocol ID
- Soh-Med-24-05-06MS
- Acronym
- rTMS
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation in Treatment of Chronic Migraine
- ClinicalTrials.gov ID
- NCT06461767
- Acronym / sponsor ID
- rTMS / Soh-Med-24-05-06MS
- Conditions
- Chronic Migraine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 17 Jun 2024 (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.
Compared with the patients with episodic migraine those with chronic migraine have worst quality of life and more severe headache related disability we investigate Repetitive transcranial magnetic stimulation in treatment and prophylaxis of chronic migraine
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- the patient will divide into 4 groups first group will receive stimulation over the left motor cortex second group will receive stimulation over left dorsolateral prefrontal cortex third group will receive stimulation over both left motor cortex and left dorsolateral prefrontal cortex fourth group will receive sham stimulation
| Arm | Type | Receives |
|---|---|---|
| group (1) will rTMS over left motor cortex | Active comparator | Device: transcranial magnetic stimulation deviceRepetitive transcranial magnetic stimulation parameters: stimulation site: left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40 |
| group (2) will receive rTMS over left dorsolateral prefrontal cortex | Active comparator | Device: transcranial magnetic stimulation deviceRepetitive transcranial magnetic stimulation parameters: stimulation site: left dorsolateral prefrontal cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40 |
| group (3) will receive rTMS over left dorsolateral prefrontal cortex and left motor cortex | Active comparator | Device: transcranial magnetic stimulation deviceRepetitive transcranial magnetic stimulation parameters: stimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40 |
| group (4) will receive sham stimulation | Sham comparator | Device: transcranial magnetic stimulation deviceRepetitive transcranial magnetic stimulation parameters: stimulation site: the coil will be perpendicular over vertex of skull intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- A study sample of patients with chronic migraine according to international classification of headache disorders-3 (ICHD-3).
- Patients are regular on follow up visits.
Key exclusion criteria (6 listed)
- Patients with depression by Hamiliton scale of depression by using its Arabic version Translated by Dr Lotfy Fateem
- patients on prophylactic medications for chronic migraine.
- pregnancy.
- cochlear implants, cardiac pacemaker, and metal body implanted in head-and-neck region.
- Patients refused to give informed consent.
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 |
|---|---|---|
| transcranial magnetic stimulation deviceRepetitive transcranial magnetic stimulation parameters: stimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 | Device | group (1) will rTMS over left motor cortex, group (2) will receive rTMS over left dorsolateral prefrontal cortex, group (3) will receive rTMS over left dorsolateral prefrontal cortex and left motor cortex, group (4) will receive sham stimulation |
Primary outcome
improvement of headache severity and number of attacks of headache before and after intervention by visual analogue scale and headache impact test
Time frame: one month after treatment
improvement of headache severity and number of attacks of headache before and after intervention by visual analogue scale and headache impact test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: Yes
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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.
Tarek Mohamed principal investigator
Sohag faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation device in people with Chronic Migraine, run by Sohag University at 1 site in Egypt.
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 2 inclusion and 6 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 18 Jun 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tarek Mohamed (01025545002, tarikmohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of headache severity and number of attacks of headache before and after intervention by visual analogue scale and headache impact test (time frame: one month after treatment). 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 Jun 2024.