Refractory MigraineNCT01670214
Pulsed Electromagnetic Field Therapy in the Refractory Migraine
A study testing pulsed electromagnetic field in people with Refractory Migraine, run by Niyayesh Clinic at 1 site in Iran.
Trial summary
Pulsed electromagnetic field (PEMF) as prophylactic treatment may prevent the attacks of migraine or decrease them even in the patients with refractory migraine. Read more about this study
- Who is it for?
- Ages 17 to 55 years
- Conditions the study is for
- Refractory Migraine
- What is being tested?
- pulsed electromagnetic field
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Jan 2012to Oct 2013
- 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 17 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Primary Diagnosis A. ICHD-II migraine or chronic migraine Refractory B. Headaches cause significant interference with function or quality of life despite modification of triggers, lifestyle factors, and adequate trials of acute and preventive medicines with established efficacy.
- Failed adequate trails of preventive medicines, alone or in combination from at least 2 of 4 drug classes:
- Beta-blockers
- Anticonvulsants
- Tricyclics
- Calcium channel blockers
Show all 14Show fewer
- Failed adequate trials of abortive medicines from the following classes, unless contraindicated:
- Both a triptan and DHE intranasal or injectable formulation
- Either nonsteroidal anti-inflammatory drugs or combination analgesics
- Adequate trial Period of time during which an appropriate dose of medicine is administered, typically at least 2 months at optimal or maximum-tolerated doses, unless terminated early due to adverse effects
- Modifiers With or without medication overuse, as defined by ICHD-2
- With significant disability, as defined by MIDAS > 11
- [DHE = dihydroergotamine; ICHD = International Classification of Headache Disorders;MIDAS = Migraine Disability Assessment]
- The prophylactic medications have been discontinued at least one month prior to enrollment
Who cannot join
- pregnancy
- epilepsy
- malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-control of Pulsed Electromagnetic Field Therapy as Preventive Treatment of Refractory Migraine
Pulsed electromagnetic field (PEMF) as prophylactic treatment may prevent the attacks of migraine or decrease them even in the patients with refractory migraine.
Read the detailed description
Migraine is most common among patients who seek medical care for headache. The prevalence of migraine is around 10 % in Iran. The many studies of migraine pathophysiology imply that the brain of migraine patient is impaired in term of cerebral circulation and baseline activity of brain stem, monoaminergic system and cortex. Then headache is only a sign of the changes that occur in the brain to rid hazardous conditions. Based on this theory many electrophysiological and imaging abnormalities that were appeared in the brain before the aura or the headache were diminished in the early phases of the attack. It means the changes concurrent with headache are associated with a quasi normalization of cortical information processing. The different pharmacological and non-pharmacological treatments have proposed for migraine management. But some patients do not satisfactorily respond to or cannot tolerate current evidence-based treatments. This group of patients is often said to have refractory migraine (RM). Thus according to the enigmatic pathophysiology of migraine, a comprehensive treatment that affected all contributing factors in the migraine with minimal side effects is not provided yet.
Extremely low frequency magnetic fields (ELF MFs) as non-pharmacological treatment of migraine had good effect with weak evidence in the control of migraine. Recently based on extensive studies in the bioeffects of the low frequency electromagnetic field we can hope that this method can respond to many human disorders is unsolvable. The purpose of this study is to apply the best effective treatment protocol of ELF-MF on brain and circulatory system is extracted by using the latest findings of studies of low-frequency electromagnetic fields as intervention and apply it for refractory migraine patients in the form of a randomized one-blind placebo- controlled trial study. The evaluation of interventions is done subjectively (migraine dairy and MIDAS). Also we consider follow up period to confirm results.
- Conditions
- Refractory Migraine
- Being tested
- pulsed electromagnetic field
- Keywords
- RM, R-CM, based on ICHD-2 criteria
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed electromagnetic fieldProcedure or surgery
parameters of the pulsed electromagnetic field are frequency:10 Hz, intensity 4-5 mT, 6 sessions( 2 week) for placebo and phase 1 treatment ( 3 sessions in week) and added 6 sessions for phase 2 treatment. the solenoid diameter of instrument is 70 cm is placed around the head.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed electromagnetic field | Active comparator | parameters of the pulsed electromagnetic field are frequency:10 Hz, intensity 4-5 mT, 6 sessions phase 1 treatment and added 6 sessions for phase 2 treatment (3 sessions per week) Receives: Procedure: pulsed electromagnetic field |
| pulsed electromagnetic field | Placebo comparator | patients are placed under off instrument while who is kept blind to know it for 6 sessions (3 sessions per week). Receives: Procedure: pulsed electromagnetic field |
What is being measured
The primary outcome is the main question the study is designed to answer.
MIDAS
migraine disability score
Measured: 6 months
headache frequency
Measured: 4 months
headache duration
Measured: 4 months
headache intensity
Measured: 4 months
Secondary outcomes (2)
medications
Measured: 4 months
missed work
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Refractory 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niyayesh Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Tehran University of Medical Sciences
- Responsible party
- Principal investigator, Boshra Hatef, Tarbiat Modarres University
- Investigators
- Boshra Hatef, Phd student PT,TMU, Principal investigator, Niyayesh Clinicmansoore toghae, prof. neurology,TUMS, Study director, sina hospital of Medical Science University of Tehran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670214
- Sponsor's protocol ID
- NIYAYESH CLINIC 1
- Status last verified
- Aug 2012
- First submitted
- 24 Jan 2012
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
B Hatef, B Majdoleslam, M Toghae, F Hashemirad. The Prophylactic Treatment of PEMF in the Refractory Migraine Headache, Double-Blind, Parallel Placebo-Controlled Study. CEPHALALGIA 33(s8): 98-99, 2013
Boshra Hatef, Fahime Hashemirad, Gholam Hossein Meftahi, Leila Simorgh, Soodeh Razeghi Jahromi, Forough Rahimi, Mansoureh ToghaThe efficiency of pulsed electromagnetic field in refractory migraine headaches: a randomized, single-blinded, placebo-controlled, parallel group. international journal of clinical trial 3(1): 24-31, 2016
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-control of Pulsed Electromagnetic Field Therapy as Preventive Treatment of Refractory Migraine
- ClinicalTrials.gov ID
- NCT01670214
- Acronym / sponsor ID
- NIYAYESH CLINIC 1
- Conditions
- Refractory Migraine
- Keywords
- RM, R-CM, based on ICHD-2 criteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Niyayesh ClinicUniversity, hospital or other
- Collaborators
- Tehran University of Medical Sciences
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 Aug 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.
Pulsed electromagnetic field (PEMF) as prophylactic treatment may prevent the attacks of migraine or decrease them even in the patients with refractory migraine.
Detailed description
Migraine is most common among patients who seek medical care for headache. The prevalence of migraine is around 10 % in Iran. The many studies of migraine pathophysiology imply that the brain of migraine patient is impaired in term of cerebral circulation and baseline activity of brain stem, monoaminergic system and cortex. Then headache is only a sign of the changes that occur in the brain to rid hazardous conditions. Based on this theory many electrophysiological and imaging abnormalities that were appeared in the brain before the aura or the headache were diminished in the early phases of the attack. It means the changes concurrent with headache are associated with a quasi normalization of cortical information processing. The different pharmacological and non-pharmacological treatments have proposed for migraine management. But some patients do not satisfactorily respond to or cannot tolerate current evidence-based treatments. This group of patients is often said to have refractory migraine (RM). Thus according to the enigmatic pathophysiology of migraine, a comprehensive treatment that affected all contributing factors in the migraine with minimal side effects is not provided yet.
Extremely low frequency magnetic fields (ELF MFs) as non-pharmacological treatment of migraine had good effect with weak evidence in the control of migraine. Recently based on extensive studies in the bioeffects of the low frequency electromagnetic field we can hope that this method can respond to many human disorders is unsolvable. The purpose of this study is to apply the best effective treatment protocol of ELF-MF on brain and circulatory system is extracted by using the latest findings of studies of low-frequency electromagnetic fields as intervention and apply it for refractory migraine patients in the form of a randomized one-blind placebo- controlled trial study. The evaluation of interventions is done subjectively (migraine dairy and MIDAS). Also we consider follow up period to confirm results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed electromagnetic field | Active comparator | Procedure: pulsed electromagnetic fieldparameters of the pulsed electromagnetic field are frequency:10 Hz, intensity 4-5 mT, 6 sessions phase 1 treatment and added 6 sessions for phase 2 treatment (3 sessions per week) |
| pulsed electromagnetic field | Placebo comparator | Procedure: pulsed electromagnetic fieldpatients are placed under off instrument while who is kept blind to know it for 6 sessions (3 sessions per week). |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Primary Diagnosis A. ICHD-II migraine or chronic migraine Refractory B. Headaches cause significant interference with function or quality of life despite modification of triggers, lifestyle factors, and adequate trials of acute and preventive medicines with established efficacy.
- Failed adequate trails of preventive medicines, alone or in combination from at least 2 of 4 drug classes:
- Failed adequate trials of abortive medicines from the following classes, unless contraindicated:
Key exclusion criteria (3 listed)
- pregnancy
- epilepsy
- malignancy
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 |
|---|---|---|
| pulsed electromagnetic fieldparameters of the pulsed electromagnetic field are frequency:10 Hz, intensity 4-5 mT, 6 sessions( 2 week) for placebo and phase 1 treatment ( 3 sessions in week) and added 6 sessions for phase 2 treatment. the solenoid diameter of instrument is 70 cm is placed around the head. | Procedure or surgery | Pulsed electromagnetic field, pulsed electromagnetic field |
Primary outcome
MIDAS
Time frame: 6 months
migraine disability score
headache frequency
Time frame: 4 months
headache duration
Time frame: 4 months
headache intensity
Time frame: 4 months
2 secondary outcomes
medications
Time frame: 4 months
missed work
Time frame: 4 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 17 Feb 2016.
- BackgroundB Hatef, B Majdoleslam, M Toghae, F Hashemirad. The Prophylactic Treatment of PEMF in the Refractory Migraine Headache, Double-Blind, Parallel Placebo-Controlled Study. CEPHALALGIA 33(s8): 98-99, 2013
- Results publicationBoshra Hatef, Fahime Hashemirad, Gholam Hossein Meftahi, Leila Simorgh, Soodeh Razeghi Jahromi, Forough Rahimi, Mansoureh ToghaThe efficiency of pulsed electromagnetic field in refractory migraine headaches: a randomized, single-blinded, placebo-controlled, parallel group. international journal of clinical trial 3(1): 24-31, 2016
- Related InfoLink provided by the sponsor.
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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.
Boshra Hatef, Phd student PT,TMU principal investigator
Niyayesh Clinic
mansoore toghae, prof. neurology,TUMS study director
sina hospital of Medical Science University of Tehran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed electromagnetic field in people with Refractory Migraine, run by Niyayesh Clinic at 1 site in Iran.
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 14 inclusion and 3 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 17 Feb 2016. 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 Iran. 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 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?
MIDAS (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01670214, which also lists 2 linked publications.
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 17 Feb 2016.