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IRCT20191214045738N1 IRCT 2020-07-11 Tabriz University of Medical Sciences The effect of light therapy on quantitative electroencephalographic features after mental fatigue induction in healthy subjects The effect of transcranial light therapy on quantitative electroencephalographic features after mental fatigue induction in healthy subjects 2020-08-24 anticipated 40 Complete https://irct.ir/trial/44323 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: A simple randomization method will be used in this study. After filling the questionnaires, each of the eligible participants will be given a code. Then a " Random number table" will be used which is a table without a specific pattern or order. The letter A will be assigned to the intervention group and the letter B will be assigned to the sham group from top to bottom, respectively. The researcher will then select the subject by tapping on any of the numbers, Blinding description: Participants in the project are unaware of the intervention or the sham. N/A Absence of any disease. Intervention 1: One square super-luminous multi-LED array source with 20 cells will apply (Iranbargh, Tehran, Iran) for TCLT in this study. The dimensions of the LED is 14mm_ 10 mm with 400 mW total radiation power. The device was calibrated before the experiment (Iranbargh, Tehran, Iran). The power density is 285 mW/cm2 and energy density is 60 J/cm2 (8). The wavelength of the LED is 850 nm. Light will emit by the LED source continuously for 2.5 minutes on the right frontal pole of the cortex (Fp2, according to the EEG 10 to 20 system. The sham group will be received the same procedure as the real intervention group, yet, they received only a 5-second light irradiation for each 1-minute of the treatment. Intervention 2: Control group: while for the other half of the participants, In the placebo group, the radiation is applied to the target area for only 5 seconds per each minute and other steps are similar. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Maryam Moghadam Salimi
Rehabilitation Faculty, Daneshgah avenue, Tabriz
Tabriz Iran (Islamic Republic of) 5167631444 +98 41 3334 5121 moghadamm@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Maryam Moghadam Salimi
Rehabilitation Faculty, Daneshgah avenue, Tabriz
Tabriz Iran (Islamic Republic of) 5167631444 +98 41 3334 5121 moghadamm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Students of Rehabilitation Faculty of Tabriz University of Medical Sciences with mean age of 18-30 years Right-handed people in the age group of 18-40. All participants' body mass index (BMI) was less than 25 Natural vision 18 years 40 years Both History of unrecognized eye diseases Neurological or orthopedic disorder of the upper extremity Sleep Disorders Pregnancy History of seizures History of neuropsychological diseases Taking medication or certain drugs that affect the nervous system Treatment - Devices Placebo One square super-luminous multi-LED array source with 20 cells will apply (Iranbargh, Tehran, Iran) for TCLT in this study. The dimensions of the LED is 14mm_ 10 mm with 400 mW total radiation power. The device was calibrated before the experiment (Iranbargh, Tehran, Iran). The power density is 285 mW/cm2 and energy density is 60 J/cm2 (8). The wavelength of the LED is 850 nm. Light will emit by the LED source continuously for 2.5 minutes on the right frontal pole of the cortex (Fp2, according to the EEG 10 to 20 system. The sham group will be received the same procedure as the real intervention group, yet, they received only a 5-second light irradiation for each 1-minute of the treatment. Control group: while for the other half of the participants, In the placebo group, the radiation is applied to the target area for only 5 seconds per each minute and other steps are similar. EEG absolute power. Timepoint: Before and after intervention. Method of measurement: EEG recording. EEG choherency. Timepoint: Before and after intervention. Method of measurement: EEG recording. Physical fatigue score. Timepoint: Before and after intervention. Method of measurement: By the Modified Fatigue Impact Scale (MFIS) questionnaire. Cognitive fatigue score. Timepoint: Before and after intervention. Method of measurement: By the MFIS questionnaire. Social Fatigue Score. Timepoint: Before and after intervention. Method of measurement: By the MFIS questionnaire. Tabriz University of Medical Sciences Approved 2020-02-18 Ethics committee of Tabriz University of Medical Sciences Rehabilitation faculty, Daneshgah avenue, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)