Comparison of the effectiveness of transcranial direct current stimulation with three approaches, anodal occipital cortex, cathodic occipital cortex and sham on clinical outcomes in patients with chronic migraine
Comparing the effectiveness of transcranial direct current stimulation with three approaches: anodal occipital cortex, cathodal occipital cortex and sham on clinical outcomes in patients with chronic migraine
Design
A clinical trial with a control group (sham), with parallel groups, double-blind, randomized, on 114 patients. The website https://www.sealedenvelope.com was used for randomization with an equal allocation ratio in each group by a non-involved person.
Settings and conduct
114 patients with chronic migraine resistant to routine treatment who referred to the pain clinic of Velayat Hospital will be included in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with chronic migraines with indications for prophylactic treatment in the age group of 18 to 65 years, resistant to drug treatments and those who experience frequent migraine attacks and take painkillers.
Exclusion criteria: history of neurological diseases, history of mental disorder and use of antipsychotic and antidepressant drugs, drug abuse during study or in the past few months, episodic migraine, history of treatment with tDCS or other brain stimulation techniques, use voltage-dependent sodium and calcium channel blockers or the patient's lack of consent to continue participating in the study.
Intervention groups
Intervention group: occipital cortex anodal tDCS group and occipital cortex cathodal tDCS group.
Control group: sham stimulation group (sham)
Main outcome variables
Number of migraine days per month, attack duration, pain intensity, frequency of taking painkillers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100501003844N5
Registration date:2023-02-15, 1401/11/26
Registration timing:prospective
Last update:2023-02-15, 1401/11/26
Update count:0
Registration date
2023-02-15, 1401/11/26
Registrant information
Name
Cyrus Emir Alavi
Name of organization / entity
Guilan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 1245
Email address
cyrusemiralavi@irimc.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of transcranial direct current stimulation with three approaches, anodal occipital cortex, cathodic occipital cortex and sham on clinical outcomes in patients with chronic migraine
Public title
The effectiveness of transcranial direct current stimulation on the clinical outcomes of chronic migraine patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic migraine
Resistant to drug treatments
Those who experience frequent migraine attacks
Experienced at least 4 attacks per month or 8 days of migraine attacks per month
Exclusion criteria:
History of neurological diseases
History of mental disorder and use of antipsychotic and antidepressant drugs
History of treatment with tDCS or other brain stimulation techniques
Taking drugs that block voltage-dependent sodium and calcium channels
Failure of the patient to continue participating in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial study, 114 patients suffering from chronic migraine and resistant to prescribed drugs, who referred to the pain clinic of Velayat Hospital, were randomly selected using the random block method using blocks of 6 and using From the website https://www.sealedenvelope.com, they will be assigned to three groups A, B, C as follows, with an equal allocation ratio in each group by a person not involved in the research.
1) anodal tDCS of the occipital cortex, anode electrode on the occipital cortex of the dominant side of pain and cathode on the chin, 2) cathodal tDCS of the occipital cortex, cathode electrode on the occipital cortex of the dominant side of pain and anode electrode on the chin of the opposite side, 3) stimulation group fake
Blinding (investigator's opinion)
Double blinded
Blinding description
To hide the allocation of drugs, they will be placed in a sealed, numbered matte envelope. The preparation of the envelopes and the random sequencing of the allocation will be done by a person not involved in the research.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
University Research and Technology Vice-Chancellor- in front of 17 Shahrivar Hospital- Shahid Siadati St. -Namjo St.
City
Rasht
Province
Guilan
Postal code
41937-13194
Approval date
2022-07-13, 1401/04/22
Ethics committee reference number
IR.GUMS.REC.1401.225
Health conditions studied
1
Description of health condition studied
Migraine patients
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Number of migraine days per month, pain intensity, frequency of taking painkillers
Timepoint
Before the start of the intervention, after the last session of the intervention and two months after
Method of measurement
Based on questions from the patient
Secondary outcomes
1
Description
Intensity of pain
Timepoint
Before the start of the intervention, after the last session of the intervention and two months after
Method of measurement
Using Visual Analogue Scale(VAS), according to patient report
Intervention groups
1
Description
Intervention group: Occipital cortex anodal tDCS groupو the anode electrode is placed on the occipital cortex on the dominant side of the pain and the cathode on the chin on the opposite side.
Category
Treatment - Devices
2
Description
Intervention group: Cathodal tDCS group of the occipital cortex, the cathode electrode is placed on the occipital cortex of the dominant side of the pain and the anode electrode is placed on the chin of the opposite side.
Category
Treatment - Devices
3
Description
Control group: The fake stimulation group (sham) also has electrodes with the same arrangement (occipital cortex and chin) and for the duration of the experimental group, with the difference that the electric current will be cut off after 30 seconds.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Pain Clinic of Velayat Hospital
Full name of responsible person
Cyrus Emir Alavi
Street address
Porsina Crossroads, Hafez Street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 911 131 7398
Email
Cyrusemiralavi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Naqipour
Street address
Shahid Siyadati St, Namjo St.
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3333 6394
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Cyrus Amir Alavi
Position
Associate Professor of Pain Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Velayat Educational and Medical Center, Namjo St.
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8814
Email
cyrusemiralavi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Cyrus Amir Alavi
Position
Associate Professor of Pain Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Velayat Educational and Medical Center, Namjo St.
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 911 131 7398
Email
Cyrusemiralavi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Cyrus Emir Alavi
Position
Associate Professor of Pain Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Velayat Educational and Medical Center, Namjo St.
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8814
Email
cyrusemiralavi@yahoo.com
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
No - There is not 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