The comparison of the effectiveness of cognitive rehabilitation therapy based on brain training, cranial electrical stimulation and their combination on attention, memory, language and visuospatial processing of patients with mild cognitive impairment
Determining the effectiveness of cognitive rehabilitation treatments based on brain training, cranial electrical stimulation and their dual combination on attention, memory, language and visual-spatial processing of patients with MCI.
Comparison of the effectiveness of cognitive rehabilitation treatments based on brain training, cranial electrical stimulation and their dual combination on attention, memory, language and visual-spatial processing of patients with MCI.
Design
The research is a single-subject experimental design with multiple baseline and follow-up. Twelve patients are equally assigned to the three groups. The sampling method is Convenience Sampling.
Settings and conduct
The study will be performed on patients with MCI referred to a psychology clinic in Isfahan. The center examiner, statistical analyst, and patients are blinded by the type of intervention of other patients
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Diagnosis of mild cognitive impairment by a psychiatrist 2- Obtaining a quorum score in ACE 3- Not suffering from mental retardation and other types of dementia (Alzheimer's, Lewy bodies, frontotemporal) 5- Not suffering from seizure including epilepsy. Exclusion criteria: 1- Dissatisfaction of the patient or family 2- Occurrence of seizures when receiving cranial electrical stimulation 3- Absence from attending a treatment session
Intervention groups
The first group is just brain training in the form of pencil-paper cognitive assignments. The second group has only electrical cranial stimulation. The third group is the cognitive tasks of pencil-paper and electrical cranial stimulation
Main outcome variables
Increasing and improving patients' scores in the subscales of attention, memory, language and visual-spatial processing based on ACE after the intervention and in the follow-up stage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210320050750N1
Registration date:2024-01-31, 1402/11/11
Registration timing:retrospective
Last update:2024-01-31, 1402/11/11
Update count:0
Registration date
2024-01-31, 1402/11/11
Registrant information
Name
Parisa Pourabadei
Name of organization / entity
The University of Lourestan
Country
Iran (Islamic Republic of)
Phone
+98 31 3662 3167
Email address
pourabadei.pa@fh.lu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-09, 1400/03/19
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectiveness of cognitive rehabilitation therapy based on brain training, cranial electrical stimulation and their combination on attention, memory, language and visuospatial processing of patients with mild cognitive impairment
Public title
Comparison of the effectiveness of brain training and CES in patients with MCI
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Receive a diagnosis of mild cognitive impairment disorder
Get a quorum score on the Addenbrooke's Cognitive Examination-R
Not having mental retardation and other types of dementia
Not having seizures and epilepsy
Exclusion criteria:
Dissatisfaction of the patient or her/ his family
Occurrence of seizures when receiving cranial electrical stimulation
Absence from a treatment session
Age
To 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In relation to blinding participants; Patients in each group are interviewed individually before entering the intervention and the treatment is fully explained to them, then the patient is free to sign the consent form or not. At this stage and during the intervention, patients in each group are not aware of the intervention provided for other patients and also none of the patients will be in contact with each other at any stage.
In relation to blinding the outcome assessor; The trained Addenbrooke's Cognitive examiner is responsible for evaluating patients at each stage of the intervention (baseline, intervention, follow-up). The examiner is not aware of the type of intervention presented to the patients and is told to evaluate the referred patients using the Addenbrooke's Cognitive Examination and to provide the therapist with the patient's test score. Therefore, the examiner is responsible for evaluating the referred patients for only 20 minutes and is not aware of the research process and intervention provided for each patient.
In relation to data analyzer blinding; Statistical analysis is performed by a statistical expert in such a way that the Addenbrooke test scores in different stages (baseline, intervention, follow-up) are presented to each patient as a separate folder and the statistical specialist is only responsible for drawing the charts. The researcher is responsible for analyzing and interpreting the results and graphs.
Placebo
Not used
Assignment
Factorial
Other design features
Use of clinical cue with the aim of identifying and accurately diagnosing cognitive defects of patients and creating a special treatment protocol for each patient.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethics committees of lorestan university of medical sciences
Street address
University of Medical Sciences, Shahid Anoushirvan Rezaei Square, Moalem St., Lorestan, Khorram Abad
City
khoramabad
Province
Lorestan
Postal code
6813833946
Approval date
2022-07-27, 1401/05/05
Ethics committee reference number
IR.LUMS.REC.1401.120
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
Use them with a score of 87 to 85 in Addenbrooke's Cognitive Examination
Timepoint
In the baseline phase, measure once a week for three weeks, In the measurement intervention phase at the end of sessions 2, 4, 6, 8 and 10 and in follow-up one month after the last session
Method of measurement
Addenbrookes;s Cognitive Exaxmination
Secondary outcomes
1
Description
Attention score on Addenbrooke's cognitive examination
Timepoint
In the baseline phase, measure once a week for three weeks, In the measurement intervention phase at the end of session 2,4,6,8,10 and in follow-up one month after the last session
Method of measurement
Addenbrooke's Cognitive Examination
2
Description
Memory score on the Addenbrooke's Cognitive Examination
Timepoint
In the baseline phase, measure once a week for three weeks, In the measurement intervention phase at the end of session 2,4,6,8,10 and in follow-up one month after the last session
Method of measurement
Addenbrooke's Cognitive Examination
3
Description
Language score on the Addenbrooke's Cognitive Examination
Timepoint
In the baseline phase, measure once a week for three weeks, In the measurement intervention phase at the end of session 2,4,6,8,10 and in follow-up one month after the last session
Method of measurement
Addenbrooke's Cognitive Examination
4
Description
Visual-spatial processing score on the Addenbrooke's Cognitive Examination
Timepoint
In the baseline phase, measure once a week for three weeks, In the measurement intervention phase at the end of session 2,4,6,8,10 and in follow-up one month after the last session
Method of measurement
Addenbrooke's Cognitive Examination
Intervention groups
1
Description
Intervention group 1: Receiving brain training by pencil-paper method. Pencil-paper exercises are offered for 10 sessions twice a week for 20 minutes.
Category
Rehabilitation
2
Description
Intervention group 2: Receiver of cranial electrical stimulation with intensity of 5 mA and frequency of 350 Hz for 30 minutes for 10 sessions twice a week
Category
Rehabilitation
3
Description
Third intervention group: This group is a double combination of the first and second group interventions. Receiver of 10 sessions of brain training and cranial electrical stimulation session (current of 5 mA and frequency of 350 Hz) as a companion of 30 minutes each session twice a week .
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Saeed Sabbaghipour's office
Full name of responsible person
Saeed Sabbaghipour
Street address
Vahid Ave.
City
Isfahan
Province
Isfehan
Postal code
8173663731
Phone
+98 31 3628 7651
Email
saeid.sabaghy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lorestan
Full name of responsible person
Dr. Mohammad Feizian
Street address
Iran, Lorestan, Khorramabad, Lorestan University
City
Khorramabad
Province
Lorestan
Postal code
6815144316
Phone
+98 66 3312 0097
Email
Chancellor@lu.ac.ir
Web page address
https://lu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Lorestan
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
The University of Lorestan
Full name of responsible person
Parisa Pourabadei
Position
PhD Student of Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Postal Code: 8173663731, Alley No. 7, Nazar Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8173663731
Phone
+98 31 3626 6963
Email
pourabadei.pa@fh.lu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Lorestan
Full name of responsible person
Parisa Pourabadei
Position
PhD Student of Psychology
Latest degree
Master
Other areas of specialty/work
Neurotherapist
Street address
Postal code:8173663731, Alley NO.7 , East Nazar St.
City
Isfahan
Province
Isfehan
Postal code
8173663731
Phone
+98 31 3626 6963
Email
pourabadei.pa@fh.lu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Lorestan
Full name of responsible person
Parisa Pourabadei
Position
PhD Student of Psychology
Latest degree
Master
Other areas of specialty/work
Neurotherapist
Street address
Postal code:8173663731, Alley No.7, East Nazar St.
City
Isfahan
Province
Isfehan
Postal code
8173663731
Phone
+98 31 3626 6963
Email
pourabadei.pa@fh.lu.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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All research documents including the data file of the participants without name and surname, consent, executive protocol and statistical tables and graphs will be shared after the end of the study.
When the data will become available and for how long
The access period starts 6 months after the publication of the articles taken out of the study.
To whom data/document is available
All employed researchers and students of domestic and foreign universities
Under which criteria data/document could be used
In order to compare with the results of other similar studies / no other statistical analysis is possible on the presented results.
From where data/document is obtainable
Contact the main researcher (Parisa Pourabadei) via e-mail to:
ppourabadi@gmail.com
What processes are involved for a request to access data/document
Applicants can send their application to the main researcher (Parisa Pourabadei) by email. They will be answered in less than 72 hours.