Determination of the effect of repeated cerebral stimulation on headache after stroke in patients referred to Rajaee Hospital
Design
During treatment, patients usually have to sit on a special chair designed for this purpose, the chin and forehead of the patient will be placed in a special frame to be fixed. This frame has been designed to prevent any unwanted movement of the patient during treatment. The holder holder is required for treatment, because the stimulus device does not touch the patient's head, it is about a few centimeters above the patient's head. During magnetism of the head, the magnetic coil should be carefully positioned at the right position, right above the patient's head, and, as a matter of fact, only the area where the doctor is intended to be treated. When the patient was ready, the physician switched on the device to turn the magnetic screw wires into a pole, and a short magnetic pulse was generated (the intervention group)Like the intervention group butthe device is off
Settings and conduct
Rajaee Hospital
Participants/Inclusion and exclusion criteria
Includes all CVA and headache patients
Each patient rate for 20 minutes to 10 sessions RTMS LOW FREQUENCY be placed on the area of the brain M1
Intervention groups
Intervention group: This treatment takes up to 6 months for each patient for 20 minutes for 10 sessions of RTQM FREQ in the M1 brain area.
In the control group:Like the intervention group but But the device is off
Main outcome variables
The headache after stroke
General information
Reason for update
Acronym
r-TMS
IRCT registration information
IRCT registration number:IRCT20181005041236N1
Registration date:2019-01-12, 1397/10/22
Registration timing:registered_while_recruiting
Last update:2019-01-12, 1397/10/22
Update count:0
Registration date
2019-01-12, 1397/10/22
Registrant information
Name
Shirinolsadat Hashemi rafsanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8807 6431
Email address
hashemirsh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-01, 1397/09/10
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of r-TMS on post-stroke headaches
Public title
r-TMS on post-stroke headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Includes all patients with CVA with headache
Exclusion criteria:
Unrelated patients with CVA، People with headache other than CVA such as migraine and tension headaches, people with malignant diseases
Non-participation in the study
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method was done by using a random number table. First, all participants were assigned a code from 1 to 48. Next, a random number was selected from the table, and the corresponding code for the patients in one of the two groups was equally divide
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient and the person who evaluates or collects the data is not known to the group
Due to the fact that in both groups the process is similar, the patient does not know the treatment
A person who does the evaluation process and record the results of the method is not implemented
Only the investigator and the technician who performs the treatment have full knowledge of the treatment
The patient is told to have one of two methods applied
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
school of medicine - shiraz university of medical science
Street address
Zand Blvd.
City
shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2018-08-06, 1397/05/15
Ethics committee reference number
IR.SUMS.MED.REC.1397.204
Health conditions studied
1
Description of health condition studied
r-TMS on post-stroke headaches
ICD-10 code
D77*
ICD-10 code description
Other disorders of blood and blood-forming organs in diseases classified elsewhere
Primary outcomes
1
Description
Determination of the mean headache after stroke in the study group before and after the procedure rtms
Timepoint
For each patient for 20 minutes for 10 sessions up to 6 months
Method of measurement
Based on the VAS scale for pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: for each patient for 20 minutes for 10 sessions of RTMS FREQ in the M1 region of the brain, this treatment lasts up to 6. In the intervention group, the chin and forehead of the patient will be placed in a special frame and, during the magnetic stimulation of the head, the magnetic coil will be adjusted precisely in the appropriate position, right above the patient's head. When the patient is ready, the physician will turn on the device until magnetic coils Changing the pole and producing a short magnetic pulsemonths
Category
Treatment - Devices
2
Description
Control group: This treatment lasts up to 6 months for each patient for 20 minutes for 10 sessions of RTMS FREQ in the M1 region of the brain. But the device is off
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajai Hospital in Shiraz
Full name of responsible person
Dr Sharareh Roshanzamir
Street address
Shiraz, Zand Avenue,Opposite Street, central Building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5645
Email
sharareh.roshanzamir@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Aghaye Dr Mohamad Javad Ashraf
Street address
Karimkhanzand Boulevard
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
sharareh.roshanzamir@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh Roshanzamir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Karim khan Zand Boulevard
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
sharareh.roshanzamir@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shareh Roshanzamir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Karimkhan zand Boulevard
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
Sharareh.roshanzamir@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh Roshanzamir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Karimkhan zand Boulevard, ,Opposite Street, central Building of Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
713484419
Phone
+98 71 3235 1087
Email
sharareh.roshanzair@gmail.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
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
Yes - There is 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
Title and more details about the data/document
Information will be provided in general and with statistical indicators
When the data will become available and for how long
Start collecting data in 1397
To whom data/document is available
If necessary, researchers working at the university
Under which criteria data/document could be used
If you submit a valid proposal
From where data/document is obtainable
Sharareh.roshanzamir@gmail.com apply to the e-mail address
What processes are involved for a request to access data/document