Comparison of the effectiveness of dorsolateral prefrontal cortex transcranial direct current stimulation and modification of frontal alpha asymmetry in the prefrontal region on patients with major depressive disorder
Comparison of the effectiveness of dorsolateral prefrontal cortex transcranial direct current stimulation and modification of frontal alpha asymmetry in the prefrontal on patients with major depressive disorder
Design
Clinical trial with repeated measures, parallel-group, open-label, randomized on 46 patients, random list generator app used for randomization
Settings and conduct
The present clinical trial is open-label by convenience sampling method. participants are invited to study by online invitation. then participants will be assessed for the presence of depressive disorder and inclusion criteria using a semi-structured interview for Diagnostic and Statistical Manual of Mental Disorders. then they will be randomly assigned to two groups of 26 people. Group 1 will receive neurofeedback. The protocol will include 15 sessions of 20 minutes in the form of increasing beta waves in the range of 15-18 Hz and decreasing alpha waves in the range of 8-12 Hz in the F3 region. Group 2 will receive brain stimulation. The protocol will include 15 sessions of 20 minutes up to a maximum of 2 mA; The anode electrode will be on the F3 region and the cathode electrode will be on the F4. Questionnaires will be administered on Assessment Day, Session 5, Session 10, Session 15, and three months after the last session.
Participants/Inclusion and exclusion criteria
Age over 18 years
Do not have any neurological disorders
Absence of psychotic disorders
Has not been on any medication or psychological treatment for up to 1 month before the start of the sessions
Be right-handed
Having depressive disorder
Intervention groups
The first group will receive stimulation on the dorsolateral prefrontal cortex, and the second group will receive neurofeedback treatment with alpha wave correction in the prefrontal cortex.
Main outcome variables
The severity of depression; feeling exhausted; Negative emotions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220316054306N1
Registration date:2022-04-04, 1401/01/15
Registration timing:prospective
Last update:2022-04-04, 1401/01/15
Update count:0
Registration date
2022-04-04, 1401/01/15
Registrant information
Name
Shahab Lotfinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 23871
Email address
lotfiniashahab@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of dorsolateral prefrontal cortex transcranial direct current stimulation and modification of frontal alpha asymmetry in the prefrontal region on patients with major depressive disorder
Public title
Comparison of the effect of dorsolateral prefrontal cortex stimulation and correction of asymmetry in alpha waves in depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
Do not have any neurological disorders
Absence of psychotic disorders
Has not been on any medication or psychological treatment for up to 1 month before the start of the sessions
Be right hand
Having depressive disorder based on a semi-structured interview
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
A code will be assigned to the people entering the study, and then each code will be randomly assigned to a group using the random list generator tool.
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 committe of Shahid Beheshti University of Medical Science
Street address
Bldg No.2 Shahid Beheshti University of Medical science, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2022-03-12, 1400/12/21
Ethics committee reference number
IR.SBMU.MSP.REC.1400.829
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Depression score in Beck Depression Inventory
Timepoint
Before the study, in sessions 5, 10, 15 and three months after the last session
Method of measurement
Using Beck Depression Inventory
2
Description
Negetive and positive affects based on scores on positive and negative affect schedule
Timepoint
Before the study, in sessions 5, 10, 15 and three months after the last session
Method of measurement
Positive and Negative Affect Schedule
3
Description
Fatigue based on multidimensional fatigue inventory
Timepoint
Before the study, in sessions 5, 10, 15 and three months after the last session
Method of measurement
Multidimensional Fatigue Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Neurofeedback protocol will include 15 sessions of 20 minutes (3 sessions per week) in the form of increasing beta waves in the range of 18-15 Hz and decreasing alpha waves in the range of 8-12 Hz in the F3 region.
Category
Treatment - Devices
2
Description
Intervention group 2: Stimulation protocol will include 15 sessions of 20 minutes (3 sessions per week) up to a maximum of 2 mA; The anode electrode will be on the F3 region and the cathode electrode will be on the F4.