The effect of photobiomodulation on cognitive and psychological tests in people with Alzheimer's disease
Design
Clinical trial with control group, with parallel, double-blind, randomized, phase 1 groups on 12 patients. Block randomization was used for randomization
Settings and conduct
The study group consists of 12 patients with mild to moderate Alzheimer's disease (based on DSM-V). Is obtained. This study will be performed in Shohada Tajrish Hospital in the years 1399-1400. Of these, 6 are treated with sham and 6 are treated with photobiomodulation for 12 weeks (randomization will be done using block randomization). How to use the device daily, for 20 minutes each time. The sessions will be conducted at home and the entire session will be viewed and recorded online by the researcher.
The control group will not have any information about the status of the device on or off.
Follow-up of the effectiveness of this method is 6 weeks and 12 weeks from the start of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: mild to moderate Alzheimer's disease, conscious satisfaction, ability to walk
Exclusion criteria: severe Alzheimer's disease, other known neurodegenerative diseases, previous history of extensive stroke
Intervention groups
6 people will be treated with sham and 6 others will be treated with photobiomodulation for 12 weeks (randomization method will be done using block randomization method). How to use the device daily for 20 minutes each time. The sessions will be conducted at home and the entire session will be viewed and recorded online by the researcher. The control group will not have any information about the status of the device on or off.
Main outcome variables
Age
Gender
DADS test
MOCA test
Hamilton test
Illness severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111121008146N35
Registration date:2021-05-23, 1400/03/02
Registration timing:registered_while_recruiting
Last update:2021-05-23, 1400/03/02
Update count:0
Registration date
2021-05-23, 1400/03/02
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-30, 1400/02/10
Expected recruitment end date
2022-04-30, 1401/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to evaluate the effect of photobiomodulation on cognitive and psychological tests in patients with Alzheimer's disease
Public title
Clinical trial to evaluate the effect of photobiomodulation on cognitive and psychological tests in patients with Alzheimer's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Alzheimer's disease by a neurologist
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
All patients are divided into case and control groups according to the table of random numbers with a ratio of 1: 1. The assigned group of individuals is placed one after the other in dark envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
The 12 patients with Alzheimer's disease will be divided into two groups of six. In one group, placebo treatment will be performed by keeping the cap off, and in the second group, photobiomodulation treatment will be performed. Follow-up of the effectiveness of this method will be done 6 and 12 weeks after the start of the study using tests of memory, cognition and function (MOCA, DADS) and psychological tests (Hamilton Anxiety and Depression).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Laser Application in Medical Sciences Research Center, Shohadaye-Tajrish Educational Hospital, Tajrish Sq, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1989934370
Approval date
2020-12-20, 1399/09/30
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.1241
Health conditions studied
1
Description of health condition studied
Alzheimer
ICD-10 code
f00
ICD-10 code description
Alzheimer disease is a primary degenerative cerebral disease of unknown etiology with characteristic neuropathological and neurochemical features. The disorder is usually insidious in onset and develops slowly but steadily over a period of several years.
Primary outcomes
1
Description
DADS Test
Timepoint
At the beginning and after the end of the laser course
Method of measurement
questionnaire
2
Description
MOCA Test
Timepoint
At the beginning and after the end of the laser course
Method of measurement
questionnaire
3
Description
Hamilton Test
Timepoint
At the beginning and after the end of the laser course
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to the usual treatment, they also use LEDs at home
Category
Treatment - Other
2
Description
Control group: This group receives only the usual treatments
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye_Tajrish Hospital
Full name of responsible person
Dr. Soror Advani
Street address
Laser Application in Medical Sciences Research Center, Shohadaye-Tajrish Educational Hospital, Tajrish Sq, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1989934370
Phone
+98 21 2271 8021
Email
Laser.cntr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sadi Banar
Street address
Laser Application in Medical Sciences Research Center, Shohadaye-Tajrish Educational Hospital, Tajrish Sq, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1989934370
Phone
+98 21 2271 8021
Email
laser.cntr@yahoo.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
Maryam Barati
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Laser Application in Medical Sciences Research Center, Shohadaye-Tajrish Educational Hospital, Tajrish Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934370
Phone
+98 21 2271 8021
Email
laser.cntr@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
NeginKimia
Position
رزیدنت مغز و اعصاب
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Laser Application in Medical Sciences Research Center, Shohadaye-Tajrish Educational Hospital, Tajrish Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934370
Phone
+98 21 2271 8021
Email
negin.kimia20166@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Negin kimia
Position
Neurology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Laser Application in Medical Sciences Research Center, Shohadaye-Tajrish Educational Hospital, Tajrish Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934370
Phone
+98 21 2271 8021
Email
negin.kimia20166@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers and craftsmen
Under which criteria data/document could be used
Email the corresponding author and earn permission
From where data/document is obtainable
Email the corresponding author
What processes are involved for a request to access data/document
Email the corresponding author, the authors' meeting, send the data at your discretion