Comparative Investigation of Effects of Neurofeedback and Transcranial Direct Current Stimulation on Attention Using Quantitative Analysis of EEG of Healthy Subjects
(1) Objectives: Comparative investigation of Effects of Neurofeedback and transcranial direct current stimulation on Attention using Quantitative Analysis of EEG of Healthy Subjects
(2) Design: randomized clinical single blinded trial, phase II clinical trail
(4) Participants including major eligibility criteria. Main inclusion criteria: male; no history of seizures; right-handedness. Main Exclusion criteria: existence of active epilepsy spots in the EEG pretest to prevent possible seizures; bio-electrical devices implanted in the body such as pacemakers.
(5) Intervention: Neurofeedback group: that benefit of a single session on reduction of beta/theta ratio neurofeedback up to 20 minutes.
TDCS group: a single session of stimulation with anodal tDCS, with a current of 1mA for 20 minutes on FP1 and FP2 while the reference electrode is placed on the neck.
Sample size: 32 healthy university students
(6) Main outcome measures (variables): in this study, theta/beta and theta/alpha frequency bands ratios and attentional task scores, pre and post intervention, are used to assess the effect size of each intervention on individual attention.
Before and immediately after interventions, the attention task run and the EEG is recorded. Data analysis and the results of psychological tests is blinding so that the analyzer will be unaware to the data of two groups.
Inclusion criteria: Healthy university student; 18-30 years old; right handed; with no medical disease such as Diabetes, Hypertension, Kidney or Liver disease; and with no Neurological diseases, like MS, and Depression, Psychotic disorders.
Exclusion criteria: The existence of active epilepsy spots in the EEG pretest to prevent possible seizures; bio-electrical devices implanted in the body such as pacemakers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022224635N2
Registration date:2016-04-27, 1395/02/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-27, 1395/02/08
Registrant information
Name
Ali Yadollahpour
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3321 1208
Email address
yadollahpour-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences (Grant No.:u-94173
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-04-18, 1395/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Investigation of Effects of Neurofeedback and Transcranial Direct Current Stimulation on Attention Using Quantitative Analysis of EEG of Healthy Subjects
Public title
Comparison of Neurofeedback and Transcranial Direct Current Stimulation Effect
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Healthy university student; 18-30 years old; right handed; with no medical disease such as Diabetes, Hypertension, Kidney or Liver disease; and with no Neurological diseases, like MS, and Depression, Psychotic disorders.
Exclusion criteria: The existence of active epilepsy spots in the EEG pretest to prevent possible seizures; bio-electrical devices implanted in the body such as pacemakers.
Age
From 18 years old to 30 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences, Research Ethics Committee
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blv, Ahvaz, Iran
City
Ahvaz
Postal code
6135715794
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.AJUMS.REC.1394.610
Health conditions studied
1
Description of health condition studied
Healthy people
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Brain electrical activity
Timepoint
Pre and post intervention
Method of measurement
EEG
2
Description
Attention
Timepoint
pre and post treatment
Method of measurement
Attention network test
Secondary outcomes
1
Description
Side effects of intervention
Timepoint
Pre and post intervention
Method of measurement
Side effect's questionnaire
Intervention groups
1
Description
Neurofeedback: Training of theta(4-7 Hz)/beta1(14-18 Hz) ratio reduction in EEG; using one channel recording in Cz of 10-20 standard system and transmission of the signals to an animation control software as a feedback; 20 minutes; one session
Category
Treatment - Other
2
Description
Transcranial Direct Current Stimulation(tDCS): A single session of stimulation with anodal tDCS, with a current of 1mA for 20 minutes on FP1 and FP2 of 10-20 standard system of EEG recording; while the reference electrode is placed on the neck.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
YadollahPour Ali
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Yadollahpour Ali
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
u-94173
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences,
Full name of responsible person
Yadollahpour Ali
Position
Faculty Member/ Ph.D Medical Physics
Other areas of specialty/work
Street address
Medical Physics Department, Faculty of Medicine, Aahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz, Iran