Determining the effect of transcranial photobiomodulation motor and cognitive areas on the balance of healthy people
Design
A controlled, single-blind, randomized, on 34 patients
Settings and conduct
Participants are evaluated in terms of balance and cognitive-attention performance. Then, Visual Stroop is used to create cognitive fatigue. Again, the participants are evaluated in terms of balance and cognitive-attention performance.
This study will be conducted in a blind way, where the participants will not know about the intervention and which group they are in.
Place: Tabriz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Right-handed people in the age range of 18 to 30 years
2) Body mass index from 19 to 25
3) Natural vision
4) Normal blood pressure (8-12 mm Hg)
Non-entry criteria:
1) History of untreated eye diseases
2) Nervous or orthopedic disorder of the upper limb
3) Sleep disorder
4) Pregnancy
5) Seizure history
6) Being left-handed
7) Taking medicine or special medicines affecting the nervous system
8) History of neurological-psychological diseases using general health questionnaire
9) Reluctance to continue attending the study
Intervention groups
The intervention using cranial fluoroscopy will be applied to only half of the participants, while the other half of the participants, i.e. the sham group, will be falsely exposed to radiation; In such a way that radiation is only applied to the desired area for 5 seconds per minute
it is possible.
Main outcome variables
Balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221206056727N1
Registration date:2023-02-05, 1401/11/16
Registration timing:prospective
Last update:2023-02-05, 1401/11/16
Update count:0
Registration date
2023-02-05, 1401/11/16
Registrant information
Name
Zoha Daei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3456 8473
Email address
zohadaei1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-02, 1402/01/13
Expected recruitment end date
2023-06-03, 1402/03/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of transcranial-Photobiomodulation on balance after mental fatigue induction in healthy subjects: a single blind clinical trial
Public title
The effect of transcranial-Photobiomodulation on balance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Right-handed people in the age range of 18 to 30 years
Body mass index from 19 to 25
Normal vision
Normal blood pressure (8-12 mmHg)
Exclusion criteria:
History of untreated eye diseases
Sleep disorder
Pregnancy
History of seizures
Being left handed
Taking medicine or special medicines affecting the nervous system
History of neurological-psychological diseases using GHQ (General Health) Questionnaire
Neurological or orthopedic disorder of the lower limb
Unwillingness to continue attending the study
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
We have two envelopes, one of which is written for men and the other for women. Inside each of them are 17 small envelopes, which of them is randomly written with sham or intervention. After entering, each person chooses the envelope related to man or woman, I take one of the small envelopes to determine whether the person will be placed in the sham or intervention group, the participant does not know his group.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be done in a blind way. The envelope related to the placement of the person in the sham or intervention group will be opened by the researcher and the participant will not know about his group.
Placebo
Not used
Assignment
Parallel
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
29 Bahman Ave, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Approval date
2022-11-22, 1401/09/01
Ethics committee reference number
IR.TBZMED.REC.1401.776
Health conditions studied
1
Description of health condition studied
Mental fatigue
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Balance
Timepoint
Before mental fatigue - after mental fatigue - after transcranial light therapy
Method of measurement
Forceplate
Secondary outcomes
1
Description
Attentional performance
Timepoint
Before mental fatigue - after mental fatigue - after transcranial light therapy
Method of measurement
Go/No go cognitive task
Intervention groups
1
Description
Intervention group: For this group, transcranial optical adjustment will be performed in one session. The light will be emitted through the use of a near-infrared light cap with a specific wavelength of 850 nm. The light will be used continuously with a power of 400 milliwatts and an energy density of 24 J/cm. The source of light production in this projector is light emitting diodes, and the desired wavelength, for 3 minutes, bilaterally on the right and left frontal areas (FP1 and FP2), supplementary motor areas (SMA) and primary motor areas. (equivalent to C3 and C4) will be irradiated. The electrodes are placed on a pre-set light cap, which is adjusted according to the electrode placement method of the 10-20 system in EEG.
Category
Rehabilitation
2
Description
Control group: The other half of the participants, i.e. the sham group, are falsely exposed to radiation; In this way, radiation is applied to the target area only for 5 seconds per minute.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Moghadam Salimi
Street address
29 Bahman Ave, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 938 272 8091
Email
zohadaei1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zoha Daei
Street address
29 Bahman Ave, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 938 272 8091
Email
m.salimi.ns@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
Maryam Moghadam Salimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
29 Bahman Ave, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 5359
Email
m.salimi.ns@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Moghadam Salimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
29 Bahman Ave, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 5359
Email
m.salimi.ns@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Moghadam Salimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
29 Bahman Ave, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 5359
Email
m.salimi.ns@gmail.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