The effect of repetitive transcranial magnetic Stimulation (rTMS) on primary visual cortex at the lesion side on improvement of visual status of patients with subcortical stroke in the posterior cerebral artery
Evaluation of the effect of repetitive transcranial magnetic stimulation (rTMS) on primary visual cortex at the lesion side on improvement of visual status of patients with subcortical stroke in the posterior cerebral artery
Design
control group patients with cortical visual field defects secondary to ischemic stroke receiving only aspirin and plavix and case patients (receiving rTMS in addition to the drugs listed). Written informed consent was included in the study. All patients over 18 years and their illness duration is at least 3 months.
Settings and conduct
Babol University of Medical Sciences, Rouhani Hospital, Vision Clinic, Bahaar Clinic
Participants/Inclusion and exclusion criteria
A total of 15 control patients with cortical visual field defects secondary to ischemic stroke receiving only aspirin and plavix and 15 case patients (receiving rTMS in addition to the drugs listed). Written informed consent was included in the study. All patients over 18 years of age and duration of illness were at least 3 months. Patients with cortical visual impairment whose lesions were outside the visual cortex, impaired visual field due to glaucoma or brain tumors, or patients. Those who were banned from using rTMS were excluded
Intervention groups
control group patients with cortical visual field defects secondary to ischemic stroke receiving only aspirin and plavix and case patients (receiving rTMS in addition to the drugs listed). Written informed consent was included in the study. All patients over 18 years and their illness duration is at least 3 months.
Main outcome variables
Visual status according to VFI & MD in primetry of pre & post stimulation with rTMS
General information
Reason for update
Acronym
rTMS
IRCT registration information
IRCT registration number:IRCT20200104046003N1
Registration date:2021-11-27, 1400/09/06
Registration timing:retrospective
Last update:2021-11-27, 1400/09/06
Update count:0
Registration date
2021-11-27, 1400/09/06
Registrant information
Name
Muhammad Abbasi Golmaaie
Name of organization / entity
Babol University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 5347
Email address
m.abbasi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of repetitive transcranial magnetic Stimulation (rTMS) on primary visual cortex at the lesion side on improvement of visual status of patients with subcortical stroke in the posterior cerebral artery
Public title
The effect of repetitive transcranial magnetic Stimulation (rTMS) on primary visual cortex at the lesion side on improvement of visual status of patients with subcortical stroke in the posterior cerebral artery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Secondary ischemic stroke with cortical visual field defects (cVFD)
Exclusion criteria:
Patients with cortical visual impairment whose lesions were outside the visual cortex, visual field defects caused by glaucoma or brain tumors, or patients who were prohibited from using rTMS
Age
From 60 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Babol University of Medical Science
Street address
Ganj Afrooze Blvd, Babol Town
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2020-02-10, 1398/11/21
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.340
Health conditions studied
1
Description of health condition studied
Visual Defects of Stroke
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Visual Fields Remission post stroke
Timepoint
3 months
Method of measurement
perimetry& VFQ-25
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patient with visual defects post stroke
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouhani Hospital
Full name of responsible person
Dr.Payaam Saadat
Street address
Ganjafroz Blvd,Rouhani Hospital
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8301
Fax
+98 11 3223 8309
Email
info@mubabol.ac.ir
Web page address
http://rohani.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.Payaam Saadat
Street address
Ganjafroz Blvd,Babol University of Medical Sciences
City
بابل
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
info@mubabol.ac.ir
Web page address
https://www.mubabol.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
The effect of repetitive transcranial magnetic stimulation (rTMS) on primary visual cortex at the lesion side on improvement of visual status of patients with subcortical stroke in
When the data will become available and for how long
2022-2023
To whom data/document is available
all of physician
Under which criteria data/document could be used
with permission of the prior writer
From where data/document is obtainable
The Email Adress of Writer
What processes are involved for a request to access data/document