]>
IRCT20210212050334N4 IRCT 2022-06-17 Rasht University of Medical Sciences Evaluation of the effect of RIPC (remote ischemic preconditioning) on migrane headache and Brain metabolites in MRS (magnetic resonance spectroscopy) and qEEG indices of migraine patients a pilot study Evaluation of the effect of RIPC (remote ischemic preconditioning) on migrane headache and Brain metabolites in MRS (magnetic resonance spectroscopy) and qEEG indices of migraine patients a pilot study 2022-08-06 anticipated 30 Complete https://irct.ir/trial/63790 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, restricted randomization method in the form of block randomization will be used to allocate patients into intervention and control groups. The "R" software will be used for randomization. For this purpose, four blocks with a ratio of 1: 1 will be considered. Sequences are marked in sealed envelopes with the letters A (intervention group) and B (control group). We will consider the size of the blocks randomly with a size of 4 to prevent the latest allocation from being detected. In the randomization process, random allocation sequences are identified by a statistician, and one student collaborators in the project will register participants and allocate them to interventions, Blinding description: In the present study, according to the type of intervention approach used, patients, nurses and physicians will be aware of the new treatment process and there is no way to not inform them and they are not blind. However,data analyzer and who assesses the patients outcomes are blind . Therefore, the present study is designed for double blinds. N/A Migraine. Intervention 1: Intervention group: Intervention group: The patient undergoes RIPC protocol 6 days a week. sphygmomanometer will be attached to the patient's arm and will be remained under the pressure of 200 mmHg for 5 minutes (ischemic phase) , followed by 5 minutes of rest (reperfusion phase). This cycle will be performed 3 times. Intervention 2: Control group: In the control group, this operation is performed as a sham or pseudo-ischemia, no pressure is applied. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It will be determined later.
public Amaneh Mohammadi Roushandeh
Anatomical Sciences department, Medicine faculty, Guilan University of Medical Sciences, Rasht, Guilan
Rasht Iran (Islamic Republic of) 4144666949 +98 13 3333 5820 mohammadi_roushandeh@gums.ac.ir Rasht University of Medical Sciences scientific Amaneh Mohammadi Roushandeh
Anatomical Sciences department, Medicine faculty, Guilan University of Medical Sciences, Rasht, Guilan
Rasht Iran (Islamic Republic of) 4144666949 +98 13 3333 5820 mohammadi_roushandeh@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Patient have at least 5 headache attacks lasting 4–72 hours (without treatment or unsuccessful treatment) Age range from 18 to 50 years The onset of migraines before menopause The ability of patients to distinguish migraine headaches from other conditions The patient's ability to fill out questionnaire Both male and female gender Informed consent 18 years 50 years Both Underlying diseases, history of chronic diseases or kidney, liver, cardiovascular, renal, pulmonary diseases, any malignancy, autoimmunity, diabetes mellitus Convulsions Menopause Head and neck trauma Asthenic damage Mental disorders and major depression according to DSM4 Botox injection in the last 6 months Pregnancy and lactation Non-migraine headaches such as tension headaches that occur more than 12 times a month and cervicogenic Drug and alcohol dependence during the 1 year prior to the study Migraine with aura History of off pump surgery Severe hypertension higher than 160/90 mm / hg Rheumatism G43.711 Chronic migraine without aura, intractable, with status migrainosus Treatment - Other Treatment - Other Intervention group: Intervention group: The patient undergoes RIPC protocol 6 days a week. sphygmomanometer will be attached to the patient's arm and will be remained under the pressure of 200 mmHg for 5 minutes (ischemic phase) , followed by 5 minutes of rest (reperfusion phase). This cycle will be performed 3 times. Control group: In the control group, this operation is performed as a sham or pseudo-ischemia, no pressure is applied. Glutamate. Timepoint: Days 0 and 60. Method of measurement: Magnetic resonance spectroscopy (MRS) test. N-acetyl aspartate. Timepoint: Days 0 and 60. Method of measurement: MRS test. Choline. Timepoint: Days 0 and 60. Method of measurement: MRS test. Creatine. Timepoint: Days 0 and 60. Method of measurement: MRS test. Myoinositol. Timepoint: Days 0 and 60. Method of measurement: MRS test. GABA. Timepoint: Days 0 and 60. Method of measurement: MRS test. Glutamate/Creatine. Timepoint: Days 0 and 60. Method of measurement: Math. NAA/Cr. Timepoint: Days 0and 60. Method of measurement: Math. Choline/Cr. Timepoint: Days 0 and 60. Method of measurement: Math. Myoinisitol/Cr. Timepoint: Days 0and 60. Method of measurement: Math. Absolute frequency bands. Timepoint: Days 0 and 60. Method of measurement: Qeeg. Relative frequency bands. Timepoint: days 0and 60. Method of measurement: Qeeg. Coherence. Timepoint: Days 0 and 60. Method of measurement: Qeeg analyze. Migraine-induced disability. Timepoint: Days 0 and 90. Method of measurement: According to the MIDAS index. Rasht University of Medical Sciences Approved 2022-03-09 Research Ethic Committees of Guilan University of Medical science Vice Chancellor of Research and Technology of Guilan University of Medical Sciences,Shahid Siadati St., Namjoo St. Rasht Guilan Iran (Islamic Republic of)