Evaluation the change in MMSE and MOCA test scores in MCI after stimulation; find biomarkers predicting response to treatment
Design
A clinical trial with an intervention group, open label, phase 2, will be conducted on 25 patients with mild cognitive impairment, without the need for randomization.
Settings and conduct
After obtaining informed consent, psychiatric history, and cognitive testing at Imam Khomeini Hospital in Sari city, baseline EEG will be obtained from MCI patients, and rTMS will be performed in the psychiatrist's clinic. The stimulation area of the left dorsolateral prefrontal cortex is considered. Quantitative EEG indices between respondents to treatment and non-responders will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The score of the MMSE questionnaire is in the range of 21-26 and the score of the Moca questionnaire is in the range of 22-26; Age over 60 years; lack of brain trauma and neurological problems such as epilepsy, stroke, brain lesions and basic psychiatric problems; not implanting a metal pacemaker or implant
Exclusion criteria :
Uncomfortable symptoms during stimulation; neurological cerebrovascular diseases and psychiatric disorders; Seizure history; continuous use of drugs and alcohol; History of accident and head trauma or craniotomy; high disease severity according to the MMSE test score; Implantation of metal objects
Intervention groups
Includes one group, patients with MMSE score 21-26 or Moca 22-26 who received stimulation with a frequency of 20 Hz, 2 seconds of stimulation and 28 seconds of pause, total duration of a period of 25 minutes with 100% RMT intensity in the left DLPFC region, for 5 days in week for 2 weeks.
Main outcome variables
The score of cognitive tests; Investigating basic QEEG biomarkers between responders and non-responders to treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240218061042N1
Registration date:2024-09-07, 1403/06/17
Registration timing:prospective
Last update:2024-09-07, 1403/06/17
Update count:0
Registration date
2024-09-07, 1403/06/17
Registrant information
Name
seyedeh masoumeh seyedhosseini tamijani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3566 1317
Email address
seyedhoseini_sm@yahoo.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-06-21, 1404/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Quantitative Electroencephalographic (QEEG) Biomarkers for Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment Response Prediction in Mild Cognitive Impairment
Public title
Quantitative Electroencephalographic (QEEG) Biomarkers for Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment Response Prediction in Mild Cognitive Impairment
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
(26 ≥MMSE score ≥ 21 or 26 ≥ MoCA score ≥ 22)
Be able to speak and understand persian language
Without history of psychosis or other significant psychiatric disorders such as major depressive disorder, heavy drink of alcohol or drug abuse, or significant neurological disorders such as stroke, history of seizure or epilepsy
Without ferromagnetic implants in the neck or head and without cardiac pacemaker
Without present in another study simultaneously
The similarity of the drug class and stable drug dose during the last 3 months
Exclusion criteria:
Severe cognitive impairment
History of psychosis or other significant psychiatric disorders such as major depressive disorder, or significant neurological disorders such as stroke, history of seizure or epilepsy
Heavy drink of alcohol or drug abuse
Ferromagnetic implants in the neck or head and cardiac pacemaker
Any physical and uncomfortable symptoms during rTMS
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
School of Advanced Technologies in Medicine, Mazandaran University of Medical Sciences, Payambar Azam Complex, Farahabad Rd., Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4847193711
Approval date
2023-12-13, 1402/09/22
Ethics committee reference number
IR.MAZUMS.REC.1402.511
Health conditions studied
1
Description of health condition studied
Mild cognitive impairment
ICD-10 code
G31.84
ICD-10 code description
Mild cognitive impairment, so stated
Primary outcomes
1
Description
The percentage of people whose short mental state questionnaire score is between 21 and 26.
Timepoint
A Mini-Mental State Examination at the beginning of the study (before the start of the intervention) and at the end of the study
Method of measurement
A Mini-Mental State Examination
2
Description
The percentage of people whose Montreal Cognitive Assessment questionnaire score is between 22 and 26.
Timepoint
Montreal Cognitive Assessment test at the beginning of the study (before the start of the intervention) and at the end of the study
Method of measurement
Montreal Cognitive Assessment test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Subjects with mild cognitive impairment received repeated transcranial magnetic stimulation with UK magstim device, with a frequency of 20 Hz, 2 seconds of stimulation and 28 seconds of pause, the total duration of a period of 25 minutes with 100% RMT intensity in the left dorsolateral prefrontal cortex, for 5 days in week and for 2 weeks.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Seyedeh Masoumeh Seyed hosseini Tamijani
Street address
The beginning of Vali Asr Highway (AJ), Joibar Three Roads,
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3304 4000
Fax
+98 11 3335 2725
Email
pajhoheshi@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Alireza Rafiee
Street address
Mazandaran University of Medical Sciences, Joibar Three Roads, the beginning of Vali Asr Highway (AJ)
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3304 4000
Email
pajhoheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Seyedeh Masoumeh Seyed hosseini Tamijani
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
School of Advanced Technologies in Medicine, Mazandaran University of Medical Sciences, Payambar Azam Complex, Farahabad Rd., Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
48471-91628
Phone
+98 11 3354 3764
Email
m.seyedhoseini@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyedeh Masoumeh Seyed hosseini Tamijani
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
School of Advanced Technologies in Medicine, Mazandaran University of Medical Sciences, Payambar Azam Complex, Farahabad Rd., Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
48471-91628
Phone
+98 11 3354 3764
Email
m.seyedhoseini@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyedeh Masoumeh Seyed hosseini Tamijani
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
School of Advanced Technologies in Medicine, Mazandaran University of Medical Sciences, Payambar Azam Complex, Farahabad Rd., Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
48471-91628
Phone
+98 11 3354 3764
Email
m.seyedhoseini@mazums.ac.ir
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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data related to MMSE and moca questionnaires
It can be shared after making people anonymous
When the data will become available and for how long