Comparing the Effects of Cognitive Training and Repetitive Transcranial Magnetic Stimulation On Improvement of Cognitive Functions and Activities of Daily Living Among Mild Cognitive impairment Individuals with High and Low Levels of Cognitive Reserve: An Embedded Study
Determining the effectiveness of cognitive training and recurrent transcranial magnetic stimulation (rTMS) on improving cognitive functions (attention, visual-spatial function, memory, executive function, language) in the elderly with mild cognitive impairment
Design
To compare the effectiveness of therapies in the groups, the required sample size in each group was calculated to be 3 subjects in each group (12 people in total), which will be selected after a diagnostic interview and from among qualified individuals.
Settings and conduct
The statistical population of the study includes all elderly people over 60 years old living in Isfahan and Kerman. Executive steps of research 1- Refer to centers for the elderly such as retirement centers, accommodation centers for the elderly (day and night accommodation centers), hospitals, and cognitive research centers 2- Clinical interview of those interested in participating in the research in accordance with DSM-5 diagnostic criteria 3- Separation of subjects with MCI in terms of cognitive reserve level 4- Implementing research tools for all participants (baseline assessment) 5 - Random assignment of subjects with MCI in four intervention groups 6- Performing all intervention sessions
Participants/Inclusion and exclusion criteria
Inclusion criteria: The subject in the NUCOG test should get a score between 75 and 85 and be over 60 years old.
Intervention groups
Four groups will participate in this study: cognitive intervention group with high cognitive reserve; Cognitive intervention group with low cognitive reserve; RTMS intervention group with high cognitive reserve; RTMS intervention group with low cognitive reserve
Main outcome variables
Analysis and comparison of two methods of cognitive training and repetitive transcranial magnetic stimulation (rTMS) taking into account the amount of cognitive reserve of individuals
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221031056347N1
Registration date:2022-11-15, 1401/08/24
Registration timing:prospective
Last update:2022-11-15, 1401/08/24
Update count:0
Registration date
2022-11-15, 1401/08/24
Registrant information
Name
Mohammad Ghaderi Rammazi
Name of organization / entity
Isfahan University
Country
Iran (Islamic Republic of)
Phone
+98 34 3252 5756
Email address
mohammade.ghaderi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-30, 1401/10/09
Expected recruitment end date
2023-01-29, 1401/11/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effects of Cognitive Training and Repetitive Transcranial Magnetic Stimulation On Improvement of Cognitive Functions and Activities of Daily Living Among Mild Cognitive impairment Individuals with High and Low Levels of Cognitive Reserve: An Embedded Study
Public title
Comparing the Effects of Cognitive Training and Repetitive Transcranial Magnetic Stimulation On Improvement of Cognitive Functions and Activities of Daily Living Among Mild Cognitive impairment Individuals
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 60 years old
NUCOG score between 75 and 85
Exclusion criteria:
Severe physical or mental disability that prevents the person from actively participating in the study
Not having the minimum level of education (reading and writing literacy)
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of University of Isfahan
Street address
No 325, 3rd Floor, Central Building, University of Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2021-09-18, 1400/06/27
Ethics committee reference number
IR.UI.REC.1400.049
2
Ethics committee
Name of ethics committee
Research Ethics Committees of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2022-03-07, 1400/12/16
Ethics committee reference number
IR.KMU.REC.1400.698
Health conditions studied
1
Description of health condition studied
Mild cognitive impairment
ICD-10 code
F06.7
ICD-10 code description
Mild cognitive disorder
Primary outcomes
1
Description
The participant's score on the Neuropsychiatry Unit Cognitive Assessment Tool (NUCOG)
Timepoint
Before intervention, Session 3, Session 7, and Session 10
Method of measurement
The Neuropsychiatry Unit Cognitive Assessment Tool (NUCOG)
2
Description
The participant's score on the Instrumental Activities of Daily Living Scale (IADL)
Timepoint
Before intervention, Session 3, Session 7, and Session 10
Method of measurement
Instrumental Activities of Daily Living Scale (IADL)
Secondary outcomes
1
Description
Cognitive functions
Timepoint
Before starting the intervention and in sessions 3, 7, and 10
Method of measurement
NUCOG TEST
2
Description
Activities of daily living
Timepoint
Before starting the intervention and in sessions 3, 7, and 10
Method of measurement
Instrumental activities of daily living scale
Intervention groups
1
Description
The first intervention group: the group of "participants with high cognitive reserve" who receive "cognitive training intervention" for 10 sessions. Cognitive intervention is carried out twice a week and lasts a total of 5 weeks. The content of various training sessions is in the following six areas:1. Memory (Episodic memory)2. Attention3. Executive Function (cognitive flexibility)4. Executive Function (inhibitory control)5. Executive Function (working memory)6. Language (word finding)
Category
Rehabilitation
2
Description
The second intervention group: the group of "participants with low cognitive reserve" who receive "cognitive training intervention" for 10 sessions. Cognitive intervention is carried out twice a week and lasts a total of 5 weeks. The content of various training sessions is in the following six areas:1. Memory (Episodic memory)2. Attention3. Executive Function (cognitive flexibility)4. Executive Function (inhibitory control)5. Executive Function (working memory)6. Language (word finding)
Category
Rehabilitation
3
Description
The third intervention group: the group of "participants with high cognitive reserve" who receive "rTMS intervention" for 10 sessions. The rTMS intervention consists of two repeated sessions of transcranial magnetic stimulation during the week, each session will last for about 20 minutes, which will last for a total of 5 weeks.
Category
Treatment - Devices
4
Description
The fourth intervention group: the group of "participants with low cognitive reserve" who receive "rTMS intervention" for 10 sessions. The rTMS intervention consists of two repeated sessions of transcranial magnetic stimulation during the week, each session will last for about 20 minutes, which will last for a total of 5 weeks.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Nouri Psychiatric Hospital
Full name of responsible person
Dr. Hojjatullah Moradi
Street address
Nouri Psychiatric Hospital, Modiriyat Three Ways, Kerman
City
Kerman
Province
Kerman
Postal code
7686112354
Phone
+98 34 3312 6606
Fax
+98 34 3312 6606
Email
info@hospnouriyeh.ir
Web page address
https://hospnouriyeh.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Isfahan
Full name of responsible person
Dr. Hadi Amiri (Deputy Research and Technology University of Isfahan)