Protocol summary

Study aim
Design
Settings and conduct
Participants/Inclusion and exclusion criteria
Intervention groups
Main outcome variables

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171023036952N1
Registration date: 2017-12-18, 1396/09/27
Registration timing: registered_while_recruiting

Last update: 2017-12-18, 1396/09/27
Update count: 0
Registration date
2017-12-18, 1396/09/27
Registrant information
Name
zahra kosari
Name of organization / entity
zanjan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 4002
Email address
zahra.psy@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
zanjan university of medical sciences
Expected recruitment start date
2017-10-07, 1396/07/15
Expected recruitment end date
2018-01-05, 1396/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of neuro-feedback therapy versus Transcranial Direct Current Stimulation (TDCS) on decreasing of migraine's signs and Anxiety, Depression and, quality of life
Public title
Comparing the effect of neuro-feedback therapy versus Transcranial Direct Current Stimulation (TDCS) on decreasing of migraine's signs and Anxiety, Depression and, quality of life
Purpose
Treatment
Inclusion/Exclusion criteria
Age
From 15 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
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
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi blvd.
City
Zanjan
Postal code
Approval date
2017-10-02, 1396/07/10
Ethics committee reference number
ZUMS.REC.1396.152

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]

Primary outcomes

1

Description
Signs of migraine
Timepoint
After 10 sessions 20 minutes - one month after treatment. Two months after the treatment
Method of measurement
Blanchard headache diary

Secondary outcomes

1

Description
anxiety
Timepoint
After 10 sessions 20 minutes - one month after treatment. Two months after the treatment
Method of measurement
Depression anxiety stress(DASS)

2

Description
Depression
Timepoint
After 10 sessions 20 minutes - one month after treatment. Two months after the treatment
Method of measurement
Depression anxiety stress(DASS)

3

Description
Quality of Life
Timepoint
After 10 sessions 20 minutes - one month after treatment. Two months after the treatment
Method of measurement
WHO QUALITY OF LIF-BREF(WHOQOL-BREF)

Intervention groups

1

Description
tdcs for 10 sessions, three times a week for 20 minutes, an anode in cz and a cattle in the poster series or oz
Category
Rehabilitation

2

Description
neurofeedback at 20 sessions a three times for 45 minutes in week . Based on the protoclothmer (suppression of 4-8 and 21-30 and amplification of 12-15) in the t3-t4 region
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Zanjan University of Medical Sciences
Full name of responsible person
Research Deputy in Zanjan University of Medical Sciences
Street address
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Research Deputy Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi blvd.
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Kosari
Position
Other areas of specialty/work
Street address
Zanjan University of Medical Sciences
City
Zanjan
Postal code
Phone
+98 24 3378 9469
Fax
Email
Zahra.psy@zums.ac.ir // zahrakosari1396@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Losari
Position
Other areas of specialty/work
Street address
Zanjan University of Medical Sciences, Azadi blvd.
City
Zanjan
Postal code
Phone
+98 24 3378 9469
Fax
Email
zahrakosari1369@gmail.com // zahra.psy@zums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Losari
Position
Other areas of specialty/work
Street address
Zanjan University of Medical Sciences, Azadi blvd
City
Zanjan
Postal code
Phone
+98 24 3378 9469
Fax
Email
zahra.psy@zums.ac.ir // zahrakosari1396@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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