Protocol summary

Study aim
Comparison of the immediate effect of the combined treatment of cognitive stimulation and direct current stimulation on the skull on the improvement of episodic memory performance in people with mild cognitive impairment.
Design
double-blind, parallel group clinical trial
Settings and conduct
60 people with mild cognitive impairment are selected through targeted and accessible sampling and randomly divided into 4 groups of 15 people.
Participants/Inclusion and exclusion criteria
Inclusion criteria 1.having a mild pathological diagnosis of amnesia by a gerontology specialist and based on the MOCA test 2.Being over 60 years old 3.right-handed 4.Not having problems in ADL using tools based on Lawton's questionnaire 5.Not having a history of other neurological problems such as stroke, MS, Parkinson's and seizures 6.Not using a cardiac device (pacemaker) in the heart or any metal prosthesis in the body 7.Not having a history of psychiatric problems such as bipolar disorder, schizophrenia and psychosis 8.Not having a history of drug use 9.Not smoking 10.Not having a history of speech therapy and cognitive therapy to improve memory 11.Being monolingual in Persian or, in case of being bilingual, having full competence in Persian language 12.Having normal or modified vision and hearing ability (with or without the use of assistive devices) exclusion criteria 1.Unwillingness to continue participating in the study 2.Occurrence of a stroke, concussion or any disease after the person entered the study that prevents him from continuing to receive treatment 3.The patient's need to use a cardiac pacemaker or any metal prosthesis in the body
Intervention groups
1. DLPFC stimulation with cognitive stimulation(CS) 2. MTL stimulation with CS 3. DLPFC and MTL stimulation with CS 4.Sham stimulation with CS
Main outcome variables
episodic memory

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221216056835N1
Registration date: 2024-08-06, 1403/05/16
Registration timing: retrospective

Last update: 2024-08-06, 1403/05/16
Update count: 0
Registration date
2024-08-06, 1403/05/16
Registrant information
Name
Shirin Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
drshiriiin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-05-24, 1402/03/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the immediate effectiveness of combined cognitive training and transcranial direct current stimulation on episodic memory function in people with mild cognitive impairement
Public title
The effect of combined cognitive stimulation and direct current stimulation on the skull on improving episodic memory performance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having a mild pathological diagnosis of amnesia by a gerontology specialist and based on the MOCA test (scoring above 26 in the MOCA cognitive assessment test), interview and Albert's diagnostic criteria Being over 60 years old Being right-handed Being monolingual in Persian or, in case of being bilingual, having full command of Persian language Having normal or modified vision and hearing ability (with or without the use of assistive devices)
Exclusion criteria:
Having a history of other neurological problems such as stroke, MS, Parkinson's and seizures Using a cardiac device (pacemaker) in the heart or any metal prosthesis in the body Having a history of drug use Smoking Having a history of speech therapy and cognitive therapy to improve memory Having problems in daily activities using tools based on Lawton's questionnaire Having a history of psychiatric problems such as bipolar disorder, schizophrenia and psychosis
Age
From 60 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
blocked randomization unit of randomization is individual Given a total of 60 participants, 8 random blocks will be required for randomization. Each block will contain 4 treatment methods arranged in a random order, with each treatment appearing twice within the block. Subsequently, these eight blocks will be placed in sealed envelopes, and the first participant entering the study will select one of the envelopes. Thus, the treatments for the first eight participants (in the same random order as specified in the selected envelope) will be determined. The ninth participant will then choose another envelope, and this process will continue until all 60 participants have completed their treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
in this study we will use 4 different tdcs protocol.each participant will receive one of four stimulation and does not know that will allocated in which group of stimulation. person who does pre and post test will not know that the participant received which kind of stimulation.In all intervention groups, an electrical stimulation cap was placed on the patients' heads, with variations in the stimulation location. During the electrical stimulation, individuals experienced a mild tingling sensation. To ensure that the sham group (the group that only had the electrical stimulation cap on their heads but did not receive any actual stimulation) remained unaware that they were not receiving electrical stimulation, a mild current was applied for the first 20 seconds and then discontinued. All groups received identical cognitive stimulation treatment during the electrical stimulation. Another person will run the tdcs protocol. this study is a double blinded study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of School of Nursing and Midwifery & Rehabilitation - Tehran University of Medical
Street address
Tehran, Enghelab street, Piche shemiran, TUMS rehabilitation faculty
City
Tehran
Province
Tehran
Postal code
111111111
Approval date
2023-01-01, 1401/10/11
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.634

Health conditions studied

1

Description of health condition studied
Mild cognitive impairment
ICD-10 code
G31.84
ICD-10 code description
Mild cognitive impairment of uncertain or unknown etiology

Primary outcomes

1

Description
Auditory Verbal Learning
Timepoint
Auditory Verbal learning is measured before and after the intervention
Method of measurement
Rey Auditory Verbal Learning Test

2

Description
Learning associations
Timepoint
Learning associations are measured before and after the intervention
Method of measurement
Wechsler Memory Test (form A)

3

Description
retelling the story
Timepoint
retelling the story is measured before and after the intervention
Method of measurement
Wechsler Memory Test (form A)

4

Description
Event memory
Timepoint
Event memory is measured before and after the intervention
Method of measurement
i don-no

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group that receives one session of 2 mA anodal tDCS in left Dorsolateral Prefrontal Cortex for 20 minutes and simultaneously to tDCS they will receive a cognitive rehabilitation treatment
Category
Rehabilitation

2

Description
The second intervention group receives one session of 2 mA anodal tDCS in medial temporal lobe for 20 minutes and simultaneously to tDCS they will receive a cognitive rehabilitation treatment
Category
Rehabilitation

3

Description
The third intervention group receives one session of 2 mA anodal tDCS in medial temporal lobe and dorsolateral prefrontal cortex for 20 minutes and simultaneously to tDCS they will receive a cognitive rehabilitation treatment
Category
Rehabilitation

4

Description
The fourth intervention group receives one session of sham tDCS in for 20 minutes and simultaneously to tDCS they will receive a cognitive rehabilitation treatment
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
the Rehabilitation School at Tehran University of Medical Sciences
Full name of responsible person
Zahra Jafari
Street address
Pich-e-Shemiran, Enghelab St.,
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
shirinjafari2004@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shirin Jafari
Street address
Keshavarz Boulevard, Quds corner
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۹۳۵۸۴۰
Phone
+98 21 6111 2904
Email
Publicrel@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ahmad Reza Khatoonabadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Pich e shemiran , Enghelab street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
a.r.khatoonabadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shirin Jafari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Pich e shemiran , Enghelab street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
shirinjafari2004@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shirin Jafari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Pich e shemiran , Enghelab street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
shirinjafari2004@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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Auditory Verbal Learning scores Verbal Learning associations scores retelling story scores
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
The applicant is only allowed to use the data for statistical analysis
From where data/document is obtainable
Shirin Jafari: Department of Speech Therapy, Rehabilitation faculty, Tehran University of Medical Sciences, corner of Safi Alishah St, Pich Shemiran, Enghelab St Mobile: 00989123961963; Email: shirinjafari2004@yahoo.com
What processes are involved for a request to access data/document
To access the research data, please specify your affiliation and tell us how you are going to use the data? After reviewing your request, the data will be sent to you after three working days.
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