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IRCT20191018045148N1 IRCT 2020-01-04 Shahid Beheshti University of Medical Sciences low level laser therapy in dementia patients Booster Effect of Low Level Laser Therapy On Cognitive Function in Treatment Resistant Dementia Patients 2019-10-23 anticipated 32 Complete https://irct.ir/trial/43149 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups of case and control using computer software. Each of the two groups will be matched for education, age, gender, and medication use, Blinding description: In this study, participants and their care givers are unaware of which group they are in. Randomization is done by software. The person who operates laser or sham treatment for patients knows which group they are in, but the person who fills out the cognitive questionnaire for patients and cognitively examines before and after treatment is unaware of which group every patient is in. 3 Dementia. Intervention 1: Intervention group: Patients in this group are treated with low level laser device. This device works with red and infrared and visible light with the wavelength of 630 and 850 nm spun from 16 infrared LEDs and 16 visible light LEDs which are located in a hat connected to the device. Each individual in the main group wears the devices cap (hat) and be treated for six sessions ten minutes each in two weeks. The clinical dementia rating (CDR) questionnaire will be filled out for each patient 3 times, first before the first treatment session, second after the last treatment session and third six weeks after the last session. Intervention 2: Control group: Patients in this group also like the main group will wear the device's cap for six sessions ten minutes each in two weeks but for this group the device won't be turned on in any sessions without them noticing. This is for the placebo effect. Also in this group the CDR questionnaire will be filled out for each patient 3 times, first before the first treatment session, second after the last treatment session and third six weeks after the last session. No - There is not a plan to make this available Justification or reason for not sharing IPD is no further imformation
public Ali Kheradmand
Erabi street Velenjak Tehran
Tehran Iran (Islamic Republic of) ۱۹۸۵۷۱۷۴۴۳ +98 21 23871 dr.alikheradmand@gmail.com Shahid Beheshti University of Medical Sciences scientific Ali Kheradmand
Erabi street Velenjak
Tehran Iran (Islamic Republic of) ۱۹۸۵۷۱۷۴۴۳ +98 21 23871 dr.alikheradmand@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) age over 60 two years of illness at least dementia f all types signing the written consent form 60 years no limit Both with a history of a major psychiatric illness with a history of head trauma benzodiazepne use substance use claustrophobic patients F03 Unspecified dementia Treatment - Devices Placebo Intervention group: Patients in this group are treated with low level laser device. This device works with red and infrared and visible light with the wavelength of 630 and 850 nm spun from 16 infrared LEDs and 16 visible light LEDs which are located in a hat connected to the device. Each individual in the main group wears the devices cap (hat) and be treated for six sessions ten minutes each in two weeks. The clinical dementia rating (CDR) questionnaire will be filled out for each patient 3 times, first before the first treatment session, second after the last treatment session and third six weeks after the last session. Control group: Patients in this group also like the main group will wear the device's cap for six sessions ten minutes each in two weeks but for this group the device won't be turned on in any sessions without them noticing. This is for the placebo effect. Also in this group the CDR questionnaire will be filled out for each patient 3 times, first before the first treatment session, second after the last treatment session and third six weeks after the last session. Changes in scores of Clinical Dementia Rating. Timepoint: before starting the treatment with laser and at the end of the treatment and six weeks after the end of the treatment. Method of measurement: Clinical Dementia Rating (CDR). Shahid Beheshti University of Medical Sciences Approved 2019-05-14 Ethics committee of Shahid Beheshti Medical University Erabi street Velenjak shahid beheshti medical university Tehran Tehran Iran (Islamic Republic of)