The purpose of this study is to evaluate the effect of trans-cranial low level laser therapy at infrared wavelengths of 850 nm and visible wavelength of 630 nm on treating cognitive and functional disorders in all types of primary dementia.
Design
A clinical trial with 32 patients in two groups of 16 main and randomized control and parallel and double blind groups
Settings and conduct
In memory clinic of Taleghani hospital in Tehran. 6 sessions each 10-minutes laser or sham therapy.The participant and the person assessing cognitive status before and after treatment are blinded
Participants/Inclusion and exclusion criteria
In this study, patients with at least 60 years of age who is at least two years passed from onset of their disease enter the study. Patients with a major psychiatric disorder, and with a history of head trauma, and who use benzodiazepine or have history of substance use or have claustrophobia are excluded.
Intervention groups
Both main and placebo controlled groups include patients with dementia of any type with cognitive impairment over 60 years of age without any major psychiatric disorders. The main group will be treated with low level laser and the control group will be treated with sham (same device but turned off)
Main outcome variables
Improve cognition and visiospatial function and possibly other dementia related symptoms such as sleep disturbance and depression in dementia patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191018045148N1
Registration date:2020-01-04, 1398/10/14
Registration timing:registered_while_recruiting
Last update:2020-01-04, 1398/10/14
Update count:0
Registration date
2020-01-04, 1398/10/14
Registrant information
Name
Sonia Donboli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4610 0558
Email address
soniadonboli@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Booster Effect of Low Level Laser Therapy On Cognitive Function in Treatment Resistant Dementia Patients
Public title
low level laser therapy in dementia patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age over 60
two years of illness at least
dementia f all types
signing the written consent form
Exclusion criteria:
with a history of a major psychiatric illness
with a history of head trauma
benzodiazepne use
substance use
claustrophobic patients
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti Medical University
Street address
Erabi street Velenjak shahid beheshti medical university
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-05-14, 1398/02/24
Ethics committee reference number
IR.SBMU.MSP.REC.1398.134
Health conditions studied
1
Description of health condition studied
Dementia
ICD-10 code
F03
ICD-10 code description
Unspecified dementia
Primary outcomes
1
Description
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)
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Ali Kheradmand
Street address
Erabi street
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
soniadonboli@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Erabi street Velenjak Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۷۴۴۳
Phone
+98 21 23871
Email
soniadonboli@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Kheradmand
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Erabi street Velenjak Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۷۴۴۳
Phone
+98 21 23871
Email
dr.alikheradmand@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Kheradmand
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Erabi street Velenjak
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۷۴۴۳
Phone
+98 21 23871
Email
dr.alikheradmand@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Kheradmand
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Erabi street Velenjak Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۷۴۴۳
Phone
+98 21 23871
Email
dr.alikheradmand@Gmail.co
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
no further imformation
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about the main outcome will be shared
When the data will become available and for how long
after year 1400 (2021)
To whom data/document is available
participants in the study
Under which criteria data/document could be used
participants in the study
From where data/document is obtainable
participants in the study
What processes are involved for a request to access data/document