The effectiveness of direct current stimulation (tDCS) and random noise stimulation (tRNS) on auditory hallucinations, depression and cognitive functions in patients with schizophrenia: a randomized, double-blind clinical trial
Determining the effectiveness of direct electric current stimulation (tDCS), random noise stimulation (tRNS) and sham stimulation in improving auditory hallucinations, depression and cognitive functions in people with schizophrenia
Design
A double-blind study with a cross-over design and a sample size of 36 patients with three intervention conditions: control, direct current stimulation (tDCS) and random noise current stimulation (tRNS).
Settings and conduct
The work will be carried out in the healing center. Patients and the principal investigator will be blinded in this study.
Participants/Inclusion and exclusion criteria
Having schizophrenia
Intervention groups
direct current stimulation (tDCS) and random noise stimulation (tRNS)
Main outcome variables
auditory hallucinations
General information
Reason for update
Acronym
tDCS , tRNS
IRCT registration information
IRCT registration number:IRCT20180724040579N4
Registration date:2023-02-12, 1401/11/23
Registration timing:prospective
Last update:2023-02-12, 1401/11/23
Update count:0
Registration date
2023-02-12, 1401/11/23
Registrant information
Name
Asgar Iranpour
Name of organization / entity
University of Mohaghegh Ardebili
Country
Iran (Islamic Republic of)
Phone
+98 45 3371 7240
Email address
iranpoursport@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-03-16, 1401/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of direct current stimulation (tDCS) and random noise stimulation (tRNS) on auditory hallucinations, depression and cognitive functions in patients with schizophrenia: a randomized, double-blind clinical trial
Public title
The effectiveness of direct current stimulation (tDCS) and random noise stimulation (tRNS) in patients with schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with schizophrenia
Exclusion criteria:
Having other mental disorders
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
36
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
During each week, patients will be placed in one of the control, tDCS, and tRNS conditions, but will not know which group they are in.
Placebo
Used
Assignment
Crossover
Other design features
Non
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Payam Noor University of Ardabil
Street address
University Street
City
Ardabil
Province
Ardabil
Postal code
5619913115
Approval date
2022-12-21, 1401/09/30
Ethics committee reference number
IR.PNU.REC.1401.446
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
The schizophrenic disorders are characterized in general by fundamental and characteristic distortions of thinking and perception, and affects that are inappropriate or blunted. Clear consciousness and intellectual capacity are usually maintained although
Primary outcomes
1
Description
auditory hallucinations
Timepoint
During brain stimulation intervention
Method of measurement
CANTAB software
Secondary outcomes
1
Description
depression and cognitive functions
Timepoint
During brain stimulation intervention
Method of measurement
CANTAB software
Intervention groups
1
Description
Control group: No electrical stimulation of the brain
Category
N/A
2
Description
Intervention group: direct current stimulation (tDCS)
Category
Treatment - Devices
3
Description
Intervention group: random noise stimulation (tRNS)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Medical Center
Full name of responsible person
Akbar Atadokht
Street address
Niaish town
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۹۹۱۱۳۶۷
Phone
+98 45 3150 5000
Email
atadokht@uma.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Payam Noor University of Ardabil
Full name of responsible person
Eisa Jafari
Street address
University Street
City
Ardabil
Province
Ardabil
Postal code
5619913115
Phone
+98 45 3351 3002
Email
dr.jafari@pnu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Payam Noor University of Ardabil
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
Payam Noor University of Ardabil
Full name of responsible person
Eisa Jafari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University Street
City
Ardabil
Province
Ardabil
Postal code
5619913115
Phone
+98 45 3351 3002
Email
dr.jafari@pnu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Payam Noor University of Ardabil
Full name of responsible person
Eisa Jafari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University Street
City
Ardabil
Province
Ardabil
Postal code
5619913115
Phone
+98 45 3351 3002
Email
dr.jafari@pnu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
Asgar Iranpour
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University Street
City
Ardabil
Province
Ardabil
Postal code
5653178171
Phone
+98 45 3359 8237
Email
Iranpoursport@yahoo.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
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available