Determining the therapeutic effects of LFPMF in reducing depressive and cognitive symptoms in dementia
Design
The clinical trial with a control group, with parallel groups, double-blind, block randomization, phase 1 on 30 patients.
Settings and conduct
The patients referred to the memory clinic of Ayatollah Taleghani Hospital in Tehran in 2023 and 2024 who met the study entry criteria were randomly selected in two groups of 15 people (control group and active group). The study is double-blind and randomization is done as block randomization. The third party arranges the samples in two groups in such a way that there is almost a similar sample in the other group in terms of age, sex, level of education, marital status, duration of the onset of the disease, and the type of medication.
Participants/Inclusion and exclusion criteria
Inclusion criteria: consent of the patient and his relatives؛ at least 60 years of age؛ at least two years have passed since the onset of the disease and treatment.
Exclusion criteria: Medications have been changed in the last 3 months؛ acute physical or psychiatric illness؛ history of neurological disease such as epilepsy and other neurological disorders such as parkinsonism؛ traumatic brain injury؛ stroke؛ acute and chronic physical illness؛ major depressive disorder؛ pseudodementia؛ Those who receive electroshock therapy؛ have claustrophobia؛ have pacemakers or shunts.
Intervention groups
30 patients with mild and moderate dementia are randomly selected into two groups of 15 people (control group and active group) and are actively or passively treated with LFPMF for 3 days every week for 30 minutes for 3 weeks. The severity of depression and cognitive symptoms before and directly after the treatment and 4 weeks after the treatment, are evaluated using MMSE, GDS.
Main outcome variables
Reduction of depression and cognitive symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230908059378N1
Registration date:2024-06-22, 1403/04/02
Registration timing:registered_while_recruiting
Last update:2024-06-22, 1403/04/02
Update count:0
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Shirinossadat Jalaleddini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2280 7505
Email address
shirin_ja@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-11-22, 1404/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of low-frequency pulsed magnetic field adjunctive therapy in depressive and cognitive symptoms in patients with dementia.
Public title
Investigating the effects of low-frequency pulsed magnetic field on dementia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least two years have passed since the onset of the disease and treatment
Consent of the patient and his relatives
At least 60 years old
Exclusion criteria:
History of neurological disease such as epilepsy and other neurological disorders(parkinsonism, traumatic brain injury, stroke)
Having claustrophobia
Having a pacemaker or shunt
Currently under ECT treatment (electroconvulsive therapy)
History of acute and chronic physical illness, major depressive disorder, pseudodementia
During the last 3 months, there have been medication changes and a new treatment has been started
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is used for randomization. The unit of randomization is the individual. Randomization is performed using statistical software and a random number table. Participants in each block are randomly assigned to one of the study groups. This study uses "double-blind" design, so neither the participants nor the researchers know which participants are in the intervention group and which are in the control group. To achieve this, a third party randomly assigns the participants to the two groups (intervention and control), each with 15 participants, in a way that ensures that the two groups are similar in terms of age, gender, education level, marital status, duration of illness, and type of medication.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the main researcher and health care personnel (doctors, nurses) who are responsible for the care of the patients are kept blind.
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
Shahid Beheshti University of Medical Sciences, Shahid Arabi St., Yamen St., velenjak
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۱۱۵۱
Approval date
2024-05-21, 1403/03/01
Ethics committee reference number
IR.SBMU.MSP.REC.1403.106
Health conditions studied
1
Description of health condition studied
Severity of depression and cognitive symptoms in patients with mild to moderate dementia
ICD-10 code
F03.9
ICD-10 code description
Unspecified dementia
Primary outcomes
1
Description
Depression score in the Geriatric Depression Scale questionnaire
Timepoint
At the beginning of the treatment (before the start of the study) and directly after the end of the treatment and 4 weeks after the end of the treatment
Method of measurement
Geriatric Depression Scale questionnaire
2
Description
Cognitive performance score in The Mini Mental State Examination
Timepoint
At the beginning of the treatment (before the start of the study) and directly after the end of the treatment and 4 weeks after the end of the treatment
Method of measurement
The Mini Mental State Examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They are treated with low-frequency pulsed magnetic field with frequencies of 10, 15 and 20 and intensity of 0.1 to 0.4 milli tesla, 3 sessions per week for 3 weeks, and each session lasts 30 minutes.
Category
Treatment - Devices
2
Description
Control group: They are treated with low-frequency pulsed magnetic field in silent mode 3 sessions per week for 3 weeks, and each session lasts 30 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Educational Hospital
Full name of responsible person
Shirinossadat Jalaleddini
Street address
Shahid Beheshti University of Medical Sciences, Shahid Arabi St., Yamen St., velenjak
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۱۱۵۱
Phone
+98 21 2243 9982
Email
shirin_ja@yahoo.com
Web page address
https://taleghani.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Shahid Arabi St., Yamen St., velenjak
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۱۱۵۱
Phone
+98 21 8820 0096
Email
zarghi@sbmu.ac.ir
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
Shirinossadat Jalaledini
Position
psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No14, Yas 1 ST., Asgarian Ave., Farmanieh
City
Tehran
Province
Tehran
Postal code
1954716713
Phone
0098 21 228075005
Email
shirin_ja@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shirinossadat Jalaledini
Position
psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No14, Yas 1 ST., Asgarian Ave., Farmanieh
City
Tehran
Province
Tehran
Postal code
1954716713
Phone
0098 21 228075005
Email
shirin_ja@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shirinossadat Jalaledini
Position
psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No14, Yas 1 ST., Asgarian Ave., Farmanieh
City
Tehran
Province
Tehran
Postal code
1954716713
Phone
0098 21 228075005
Email
shirin_ja@yahoo.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
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals..
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Researchers working in academic and scientific institutions. For the treatment of patients and scientific research.
From where data/document is obtainable
Dr Shirinossadat Jalaleddini
shirin_ja@yahoo.com
09128247498
What processes are involved for a request to access data/document