The Efficacy of High Definition anodal transcranial direct current stimulation in treatment of patients with Mild Cognitive Impairment (MCI), A Randomized, double-blind, parallel-controlled clinical trial
Evaluation of the efficiency of high quality anodal transcranial direct current stimulation in the treatment of patients with mild cognitive impairment
Design
This randomized clinical trial design is a parallel design with a control group.
This study is a randomized, phase 2-3 will be performed on 90 patients with mild cognitive impairment. Random blocks are used for randomization and participants are assigned to three groups.
Settings and conduct
This study, which will be performed at the Kerman Neuroscience clinic, is a double-blinded one. To send direct current to the scalp, ring-shaped electrodes of Ag / AgCl will be used. The anodic electrodes will be placed on the scalp on a pre-defined area in each patient by a special plastic clamp filled with a conductive gel on the scalp.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of mild cognitive impairment; The duration of symptoms of mild cognitive impairment is at least one year.
Exclusion criteria: Epilepsy; Taking any medication that affects the central nervous system; Focal neurological defects in neurological examination Scalp diseases; Previous intracranial surgery
Intervention groups
In the first intervention group, anodic TDCS stimulation is performed on the left prefrontal dorsolateral cortex with a current of 2 mA for 20 minutes 5 days a week, for two weeks. In the second intervention group, anodic TDCS stimulation will be performed on the anterior temporal cortex with a current of 2 mA for 20 minutes, 5 days a week, for two weeks. The third group will receive Sham stimulation for only 60 seconds (5 days a week, for two weeks) but the electrodes will remain in their place for 20 minutes.
Main outcome variables
Quality of Life, Cognitive status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N163
Registration date:2021-03-21, 1400/01/01
Registration timing:prospective
Last update:2021-03-21, 1400/01/01
Update count:0
Registration date
2021-03-21, 1400/01/01
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-10-12, 1400/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of High Definition anodal transcranial direct current stimulation in treatment of patients with Mild Cognitive Impairment (MCI), A Randomized, double-blind, parallel-controlled clinical trial
Public title
The Efficacy of transcranial direct current stimulation in treatment of patients with Mild Cognitive Impairment (MCI)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of mild cognitive impairment
Education level 4 or more
The duration of symptoms of mild cognitive impairment is at least one year
Exclusion criteria:
Epilepsy; Taking any medication that affects the central nervous system
Focal neurological defects in neurological examination
Scalp diseases
Previous intracranial surgery, metal inside the head (outside the mouth) such as shrapnel, surgical clips
History of recurrent or severe headaches
Age
From 55 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Using random blocks. First, the size of each block is determined by 3, then all the triple permutations (for three interventions, for example, A, B, C) are determined. In this step we will have 6 possible permutations (ABC / ACB / BAC / BCA / CBA / CAB) for each block. Finally, 30 blocks with random permutations and in each block, 3 samples with one of the 6 possible permutations will be assigned to three intervention, that in total 90 samples with the same volume will be assigned to three groups. It should be noted that random numbers will be used to assign each permutation in each block.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, patients and researchers are unaware of the coding of intervention groups and TDCS stimulation will be performed by a clinical caregiver.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-02-11, 1399/11/23
Ethics committee reference number
Ir.kums.rec.1399.42
Health conditions studied
1
Description of health condition studied
Mild cognitive disorder
ICD-10 code
F06.7
ICD-10 code description
Mild cognitive disorder
Primary outcomes
1
Description
Quality of Life
Timepoint
Before the intervention and three months after the end of the intervention
Method of measurement
Using a quality of life questionnaire
2
Description
Cognitive status
Timepoint
Before stimulation, after the second week, one and three months after the end of the study
Method of measurement
Using the Montreal Cognitive Test (MoCA)
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, anodic TDCS stimulation is performed on the left prefrontal dorsolateral cortex with a current of 2 mA for 20 minutes 5 days a week, for two weeks.
Category
Other
2
Description
In the second intervention group, anodic TDCS stimulation will be performed on the anterior temporal cortex with a current of 2 mA for 20 minutes, 5 days a week, for two weeks.
Category
Other
3
Description
The third group will receive Sham stimulation for only 60 seconds (5 days a week, for two weeks) but the electrodes will remain in their place for 20 minutes.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman University of Medical Sciences, Neuroscience Research Center
Full name of responsible person
Dr. Soheila Rezakhani
Street address
Kerman Neuroscience Research Center, Tahmasbabad intersection in front of Besat Clinic
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 4196
Email
drrezakhani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kerman University of Medical Sciences
Full name of responsible person
Dr. Soheila Rezakhani
Position
Faculty member of Kerman University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
Kerman Neuroscience Research Center, Tahmasbabad intersection in front of Besat Clinic
City
Kerman
Province
Kermanshah
Postal code
3432264180
Phone
+98 34 3226 4196
Email
drrezakhani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mahmoud Amiri
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
Medical Biology Research Center, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6714415185
Phone
+98 83 3427 6473
Email
ma_amiri_bme@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Soheila Rezakhani
Position
Faculty member of Kerman University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
Kerman Neuroscience Research Center, Tahmasbabad intersection in front of Besat Clinic
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 4196
Email
drrezakhani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
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