Comparison of the effects of Botox and rTMS on reducing migraine symptoms
Design
Clinical trial with two intervention groups, with parallel groups, without blinding, non-randomized, phase 3 on 100 patients.
Settings and conduct
Botox: Botox 500 units are injected into specific areas of the head and neck over a period of 3 months according to standard FDA protocol.
rTMS is a high-frequency (10-20 Hz) repetitive transcranial magnetic stimulation device that is used to stimulate the motor cortex. 15-20 sessions, each session lasting 20 minutes, will be administered over a period of 3 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 25 to 55 years
Suffering from migraine
Exclusion criteria:
Pregnant or lactating women
Suffering from brain tumors
Patients with metal implants in the head and neck
Sensitivity to Botox
Intervention groups
Group 1: Received Botox treatment.
Group 2: Received repetitive transcranial magnetic stimulation (rTMS) treatment.
Main outcome variables
Change in the number of migraine attacks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251022067727N1
Registration date:2025-11-26, 1404/09/05
Registration timing:prospective
Last update:2025-11-26, 1404/09/05
Update count:0
Registration date
2025-11-26, 1404/09/05
Registrant information
Name
Mehrnoosh Ghaneifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 1739
Email address
ghaneifarmehrnoosh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-21, 1404/09/30
Expected recruitment end date
2026-03-21, 1405/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Botox and rTMS on reducing migraine symptoms
Public title
Comparing the effects of Botox and rTMS on reducing migraine symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 25 to 55 years
Suffering from migraine
Exclusion criteria:
Pregnant or lactating women
Suffering from brain tumors
Patients with metal implants in the head and neck
Sensitivity to Botox
Age
From 25 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Tehran Islamic Azad University of Medical Sciences
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2025-09-01, 1404/06/10
Ethics committee reference number
IR.IAU.TMU.REC.1404.254
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Change in the number of migraine attacks
Timepoint
Before treatment, one, three and six months after treatment
Method of measurement
Interview and taking a history
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Botox injections of 500 units are performed over a period of 3 months at specific points on the head and neck according to standard FDA protocol.
Category
Treatment - Drugs
2
Description
Intervention group: rTMS is a magnetic stimulation technique that uses a high-frequency (10-20 Hz) repetitive magnetic stimulation device to stimulate the motor cortex. 15-20 sessions, each treatment session lasting 20 minutes, will be performed for 3 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farhikhtegan Hospital, Tehran
Full name of responsible person
Mehrnoush Ghaneifar
Street address
Shohadaye Hesarak Blvd, Hesarak, Tehran
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4486 7262
Email
ghaneifarmehrnoosh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Parsania
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
ghaneifarmehrnoosh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mehrnoush Ghaneifar
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
ghaneifarmehrnoosh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehrnoush Ghaneifar
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
ghaneifarmehrnoosh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehrnoush Ghaneifar
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
ghaneifarmehrnoosh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD