General purpose: Investigating the effect of neural modulation on verbal fluency in healthy people
Specific purposes:
1- Investigating the effect of neural modulation on the improvement of phonemic verbal fluency skills in healthy people
Investigating the effect of neural modulation on the improvement of semantic verbal fluency skills in healthy people.
Design
A clinical trial with a control group, a single intervention, a blind strain, randomized on 30 healthy people.
A table of random numbers will be used for randomization.
Settings and conduct
For blinding one strain, when we want to perform unrealistic radiation on the cerebral cortex of people in the control group, we will turn off the light irradiation device and continue our work without the person noticing.
The location of the study will be the Brain and Cognitive Laboratory, Faculty of Rehabilitation Sciences, Tabriz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Entry requirements:
1- Age range 18-40 years
2- General health of the participants
3- Mastery of Persian language
Non-entry conditions:
1- History of neurological, psychological diseases and speech and language disorders
Intervention groups
The considered groups include intervention and control groups. People in the intervention group will be exposed to near-infrared light, and the control group will not be exposed to real radiation.
Main outcome variables
1- Phonemic verbal fluency score in healthy people before and after the intervention
2-Semantic verbal fluency score in healthy people before and after the intervention
General information
Reason for update
Acronym
NMVFS
IRCT registration information
IRCT registration number:IRCT20221109056449N1
Registration date:2023-04-24, 1402/02/04
Registration timing:retrospective
Last update:2023-04-24, 1402/02/04
Update count:0
Registration date
2023-04-24, 1402/02/04
Registrant information
Name
faezeh hemmati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 6284
Email address
faezehhemmati95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-03, 1401/09/12
Expected recruitment end date
2023-04-01, 1402/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of neural modulation on verbal fluency skill in healthy individuals
Public title
Investigating the effect of near-infrared light radiation on the cerebral cortex and verbal fluency in healthy people
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants should have good general health.
Participants should be between 18-40 years old.
The participants should have natural comprehension and expression skills in Persian language.
Exclusion criteria:
Participants must have a history of neurological, psychological diseases and language and speech disorders.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be divided into two intervention and control groups by a simple random assignment method, and we will use the random number table tool for this.
Blinding (investigator's opinion)
Single blinded
Blinding description
For blinding of one strain, after people are placed in the intervention and control groups, we will not tell them which group they are in, and the near-infrared light radiation is performed in the intervention group. In the control group, so that the participant does not notice, after one second of radiation, we turn off the device and pretend that radiation is taking place.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2021-09-13, 1400/06/22
Ethics committee reference number
IR.TBZMED.REC.1400.582
Health conditions studied
1
Description of health condition studied
Verbal Fluency In Healthy People
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Semantic And Phonemic Verbal Fluency Score In Healthy People
Timepoint
Measuring phonemic and semantic verbal fluency scores at the beginning of the study and after near-infrared light irradiation.
Method of measurement
Verbal Fluency Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: an intervention group and a control group (comparison). The intervention group will receive one dose of near-infrared light with a wavelength of 850 nm and an energy of 60 m J for 10 minutes.
Category
Rehabilitation
2
Description
Control group: People in the control group will be exposed to near-infrared light, but after one second, the device will turn off without them noticing, and it will continue for 10 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Faezeh Hemmati
Street address
No. 26, Mohajeri Alley., Chaiknar., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5154793580
Phone
+98 41 3334 6284
Email
faezehhemmati95@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Parviz Shahabi
Street address
Research and Technology Vice-Chancellor., Third Floor., Central Building No. 2, Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7311
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ali Jahan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Faculty of Rehabilitation Sciences., Tabriz University of Medical Sciences., Golgasht Street., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7311
Email
shishez@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Jahan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Faculty of Rehabilitation Sciences., Tabriz University of Medical Sciences., Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7311
Email
shishez@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Jahan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Faculty of Rehabilitation Sciences., Tabriz University of Medical Sciences., Golgasht St., Tabriz
City
تبریز
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7311
Email
shishez@yahoo.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
Due to the confidentiality of participants' information
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