We sought to answer the question that the combination of these two methods "extremely low frequency pulsed electromagnetic field and low level laser therapy" could be more effective on acute stroke?
Design
This study was designed as a single-blind randomized clinical trial. According to a computer-generated randomization schema, the eligible 52 patients were randomly assigned into two groups: patients (n=26) and control group (n=26).
Settings and conduct
Stroke patients admitted to Shohahda Hopital Neurology Ward, Tehran, Iran
Participants/Inclusion and exclusion criteria
Not receiving anti thrombolytic therapy; aged over 18 years old; the first stroke; hemisphere; symptoms begin over the last 48 hours; NIHSS> 4 and stable patient with steady clinical awareness and ability to perform simple voice commands.
Intervention groups
EMF-ELF at 1 mT for 5 days per day from 45 minutes and an infrared laser with a wavelength of 840 nm and 12 watts
Main outcome variables
Mini Mental Status Exam NIHSS; Barthel’s index; Geriatric Depression Scale and modified Rankin Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180913041031N1
Registration date:2019-05-28, 1398/03/07
Registration timing:retrospective
Last update:2019-05-28, 1398/03/07
Update count:0
Registration date
2019-05-28, 1398/03/07
Registrant information
Name
Amir Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8001
Email address
amir_rezaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-27, 1397/04/06
Expected recruitment end date
2018-11-27, 1397/09/06
Actual recruitment start date
2018-06-27, 1397/04/06
Actual recruitment end date
2018-12-27, 1397/10/06
Trial completion date
2018-12-27, 1397/10/06
Scientific title
Efficacy of extremely low frequency pulsed electromagnetic field and low level laser therapy on acute stroke
Public title
Effect of Electromagnetic field and laser on Stroke
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Older than 18 yo
First episode of ischemic stroke
Involvement of only one hemisphere
Symptoms begins in less than 48 hours ago
Conscious
Clinically stable
Can performe simple verbal commands
Signed informed consent form
Exclusion criteria:
Acute ICH
Past history of ischemic or hemorrhagic stroke
Past history of seizure
Particiating in another clinical trial
mRS score>1 before trial
Lacunar infarct
Pregnancy
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
52
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization sequence was created using Excel 2016 (Microsoft, Redmond, WA, USA) with a 1:1 allocation using random block sizes of 2 by an independent doctor.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patient put the hat on his head but he/she is not aware that the devise is turned on/off.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Shadid Behshti University of Medical Sciences
Street address
Next to Taleqani Hospital. , A'rabi St, Yemen St
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-06-26, 1397/04/05
Ethics committee reference number
IR.SBMU. MSP.REC.1397.331
Health conditions studied
1
Description of health condition studied
Acute ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Laser therapy and Electromagnetic Field can cause significant increase in NIHSS score.
Timepoint
At the beginning of trial and after 45 days
Method of measurement
Questionnaire
2
Description
Laser therapy and Electromagnetic Field can cause significant increase in MMSE score.
Timepoint
At the beginning of trial and after 45 days
Method of measurement
Questionnaire
3
Description
Laser therapy and Electromagnetic Field can cause significant increase in GDS score.
Timepoint
At the beginig of trial and after 45 days
Method of measurement
Questionnaire
4
Description
Laser therapy and Electromagnetic Field can cause significant increase in Barthel 's index score.
Timepoint
At the beginning of trial and after 45 days
Method of measurement
Questionnaire
5
Description
Laser therapy and Electromagnetic Field can cause significant increase in MRS score.
Timepoint
At the beginning of trial and after 45 days
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
EMF_ELF (1mt) for 5 consequtive days up to 45 mins and infrared laser with 840nm (12w)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Amir Rezaei
Street address
Shahrdari ST , Tajrish Sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
amir_rezaei@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Next to Taleqani hosp, A'rabi St., Yemen St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Rezaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Shohadaye Tajrish hospital, Tajrish Sq.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8001
Fax
Email
amir_rezaei@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Rezaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Shohadaye Tajrish hospital, Tajrish Sq.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8001
Fax
Email
amir_rezaei@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Rezaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Shohadaye Tajrish hospital, Tajrish Sq.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8001
Fax
Email
amir_rezaei@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Yes - There is 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 whole information can be given to researchers as needed
When the data will become available and for how long
from april 2019
To whom data/document is available
researchers whom working at scientific institute
Under which criteria data/document could be used
if there in no contradiction due to our institute regiulation we are very please to do this matter.
From where data/document is obtainable
Dr. Amir Rezaei
Shohada tajrish Hospital, Tehran
amir_rezaei@sbmu.ac.ir
What processes are involved for a request to access data/document
after consulting with chancellor in research affairs we are very pleased to handle the informatins.