Evaluation of the effectiveness of treatment with Trans cranial direct current stimulation in comparison with Repetitive Trans cranial Magnetic Stimulation in improving pain, anxiety, depression and quality of life in patients with migraine
Evaluation of the effectiveness of treatment with Transcranial direct current stimulation in comparison with Repetitive Transcranial Magnetic Stimulation in improving pain, anxiety, depression and quality of life in patients with migraine
Design
Clinical trial with two parallel groups of intervention, without blinding, randomized, phase 2 on 72 patients
Settings and conduct
In this randomized clinical trial study without blindness, 72 migraine patients candidate for TDCS and RTMS referred to Kashani Hospital in Isfahan will be divided into two groups. One group will be treated with TDCS and the other group will be treated with RTMS. Then pain intensity, depression,anxiety and quality of life score will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion: Patients with migraine and a history of migraine attacks in the past year.
Not inclusion: Any Contraindications for TDCS and RTMS, history of any brain stimulation and any major Psychiatric disorders
Intervention groups
TDCS intervention group: electrical stimulation with intensity of 2 mA will be delivered in the Dorsolateral Prefrontal cortex, in twelve sessions,every other day.
RTMS intervention group: Magnetic stimulation with a frequency of 10 Hz, 600 pulses in 10 trains for 412 seconds and 70% stimulation threshold of each person will be delivered in the Dorsolateral Prefrontal cortex, in three sessions every other day.
Main outcome variables
Pain intensity; Depression score; Anxiety score; Quality of life score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190404043159N4
Registration date:2021-10-09, 1400/07/17
Registration timing:prospective
Last update:2021-10-09, 1400/07/17
Update count:0
Registration date
2021-10-09, 1400/07/17
Registrant information
Name
Mohammad Reza Sharbafchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2475
Email address
sharbafchi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of treatment with Trans cranial direct current stimulation in comparison with Repetitive Trans cranial Magnetic Stimulation in improving pain, anxiety, depression and quality of life in patients with migraine
Public title
Comparison of the effect of TDCS and RTMS in the treatment of migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All 18 to 60 years old migraine patients with the code (ICHS-II 1.2.1) according to the International Classification of Headache Disorders (2004) and with a history of migraine attacks (of any severity) during a recent year that is confirmed by a neurologist.
Conscious consent to participate in the study
Have a minimum literacy
Exclusion criteria:
A serious suicide plan or thoughts
Pregnancy or Breastfeeding
Substance abuse
A history of seizures or any neurological disease (other than Migraine)
Having a Pacemaker or any metal Implants in the upper limbs or head and neck
History of any brain stimulation such as ECT(Electroconvulsive therapy)
7. History of taking antidepressants and anti-anxiety drugs from two months before entering the study
Depressive, Bipolar, or Psychotic disorders based on DSM-V (Diagnostic and Statistical Manual of Mental Disorders ) Criteria during examination by a Psychiatrist and Psychiatric Assistant
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The double random blocks method is used for randomization.
In this way, both eligible patients are placed in a block and are arranged according to the national code, and a table of random numbers is used to determine the placement of patients in groups A or B. Numbers 0 to 4 will be in group A and numbers 5 to 9 will be in group B. Then, by tossing a coin, treatment method A is assigned to one method and B to the other treatment method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan university of Medical sciences
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
Approval date
2021-08-02, 1400/05/11
Ethics committee reference number
IR.MUI.MED.REC.1400511
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Pain intensity based on Visual Analogue Scale (VAS)
Timepoint
At the beginning of the study and one month after the intervention
Method of measurement
Pain intensity based on Visual Analogue Scale (VAS)
2
Description
Depression score
Timepoint
At the beginning of the study and one month after the intervention
Method of measurement
Based on the Hospital Anxiety and Depression Scale (HADS)
3
Description
Anxiety score
Timepoint
At the beginning of the study and one month after the intervention
Method of measurement
Based on the Hospital Anxiety and Depression Scale (HADS)
4
Description
Quality of life score
Timepoint
At the beginning of the study and one month after the intervention
Method of measurement
Based on the Headache Impact Test (HIT) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with migraine will be treated with electrical stimulation by the TDCS method with a intensity of 2 mA in the Dorsolateral Prefrontal cortex, in twelve sessions, every other day.
Category
Treatment - Devices
2
Description
Intervention group: Patients with migraine treated with magnetic stimulation by RTMS method, with a frequency of 10 Hz, 600 pulses in 10 trains for 412 seconds and 70% of the stimulation threshold of each person in the Dorsolateral Prefrontal cortex,in three sessions, every other day.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospial
Full name of responsible person
Mohammad Reza Sharbafchi
Street address
Kashani St.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
sharbafchi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Fax
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Sharbafchi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
sharbafchi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Sharbafchi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
sharbafchi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Sharbafchi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
sharbafchi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available