Efficacy of Mindfulness-Based Intervention and Transcranial Direct Current Stimulation (TDCS) on Cognitive Disorders, and emotional problems in patients with stroke: a randomized clinical trial
To investigate the efficacy of Mindfulness-Based intervention and TDCS on cognitive and emotional problems in stroke patients
Design
A randomized, blinded, controlled clinical trial with a parallel group design of a total of 72 patients (4 groups of about 18 stroke cases)
Settings and conduct
This project will be performed in Imam Reza Hospital, Tabriz, Iran. In electrical stimulation by TDCS, the anodal electrode will be placed in the left dorsolateral prefrontal cortex (F3) and the cathodal electrode in the contralateral right dorsolateral prefrontal cortex (F4) and 2 mA electricity flows is passed from participants’ skull directly for 20 minutes during 10 sessions. In the mindfulness intervention group, participants will be trained by Kabat-Zinn mindfulness-based stress reduction treatment program (2003) during eight sessions for 2.5 hours. Data will be analyzed by Multivariate Analysis of Variance (MANCOVA).
Participants/Inclusion and exclusion criteria
Inclusion/ Exclusion criteria: age of 30-70 years, educated, acceptance of informed consent, the possibility to follow up and no involvement of the language area in the brain, no history of past stroke or psychiatric disease
Intervention groups
Mindfulness group, TDCS group, both mindfulness and TDCS group, and control group taking standard treatment without the interventions.
Main outcome variables
Changes of cognitive scores will be assessed by Eden Brook cognitive examination and emotional impairments scores by Beck anxiety and depression questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090716002195N3
Registration date:2019-07-31, 1398/05/09
Registration timing:registered_while_recruiting
Last update:2019-07-31, 1398/05/09
Update count:0
Registration date
2019-07-31, 1398/05/09
Registrant information
Name
Mehdi Farhoudi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41100983340730
Email address
farhoudim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-06, 1398/04/15
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Mindfulness-Based Intervention and Transcranial Direct Current Stimulation (TDCS) on Cognitive Disorders, and emotional problems in patients with stroke: a randomized clinical trial
Public title
Efficacy of Mindfulness and TDCS on patients with stroke
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
No involvement of language area in left hemisphere
Unilateral brain involvement
After 3 months of recent stroke
Possiblity to write and read
Signing of the informed consent
Available and possible to follow-up
Exclusion criteria:
Language area involvement (aphasia)
Past history of stroke
Past history of psyciatric disease
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization and explanation, block
Blinding (investigator's opinion)
Double blinded
Blinding description
The person performing mindfulness and TDCS will be separate from persons working on outcome and analysis of data.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Local Ethic Committee of Tabriz University of Medical Sciences
Street address
Neurosciences Research Center, Imam Reza Hospital, Gholghast Street
City
Tabriz
Province
East Azarbaijan
Postal code
51566614756
Approval date
2018-08-06, 1397/05/15
Ethics committee reference number
IR.TBZMED.REC.1397.430
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I63.3, I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Change of cognitive scale
Timepoint
Before intervention and after 10 sessions of TDCS therapy and after 8 sessions of Kabat-Zinn mindfulness-based stress reduction treatment program
Method of measurement
Addenbrooke's Cognitive Examinations
2
Description
Change of emotional scale
Timepoint
before intervention and after 10 sessions ofTDCS therapy and after 8 sessions of Kabat-Zinn mindfulness-based stress reduction treatment program
Method of measurement
Beck's depression and anxiety inventories
Secondary outcomes
empty
Intervention groups
1
Description
First group: TDCS intervention, for this purpose, 2 mA electricity flows is passed from participants’ skull directly for 20 minutes during 10 sessions.
Category
Rehabilitation
2
Description
Second Group: mindfulness intervention, participants will be trained by Kabat-Zinn mindfulness-based stress reduction treatment program (2003) during eight sessions for two and a half hours.
Category
Rehabilitation
3
Description
Third Group: intervention by TDCS + Mindfulness, for this purpose, 2 mA electricity flows is passed from participants’ skull directly for 20 minutes during 10 sessions and after that participants will be trained by Kabat-Zinn mindfulness-based stress reduction treatment program (2003) during eight sessions for two and a half hours.
Category
Rehabilitation
4
Description
Fourth group: control group, will not receive any of the interventions.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza medical research and training hospital
Full name of responsible person
Mehdi Farhoudi
Street address
Golgasht street , Imam Reza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 0730
Fax
+98 41 3334 0730
Email
nsrc@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Cognitive Sciences and Technologies Council
Full name of responsible person
Mehdi Farhoudi
Street address
Golgasht street , Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 0730
Fax
+98 41 3334 0730
Email
farhoudi_m@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cognitive Sciences and Technologies Council
Proportion provided by this source
100
Public or private sector
Private
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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Farhoudi
Position
Professor of Neurology
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Neurosciences Research Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 0730
Fax
+98 41 3334 0730
Email
farhoudi_m@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Farhoudi
Position
Professor of Neurology
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Golgasht street , Tabriz university of medical siences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 0730
Fax
+98 41 3334 0730
Email
Farhoudim@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University
Full name of responsible person
Atekeh Mosanaei
Position
Master of psycology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Neurosciences research Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 0730
Email
atekeh.mosanaei@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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
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