IRCT | Investigating the effects of transcranial direct current stimulation (tDCS) combined with computer-based cognitive rehabilitation on brain mapping and cognitive functions in individuals with amnestic mild cognitive impairment (a-MCI)

Protocol summary

Study aim: Investigating the combined effect of transcranial direct current stimulation (tDCS) of the left temporal pole along with computer-based cognitive rehabilitation on brain maps and cognitive functions in individuals with mild cognitive impairment of the amnesic type (a-MCI): A study based on brain maps and neuropsychological assessment
Design: A randomized, double-blind, parallel-group controlled clinical trial on 30 individuals with a-MCI.
Settings and conduct: Thirty individuals diagnosed with mild cognitive impairment of the amnesic type in the city of Isfahan will be divided into two groups after meeting the entry criteria and will undergo paper-and-pencil and computer assessments, as well as electroencephalography (EEG). The intervention will consist of real and sham stimulation accompanied by cognitive rehabilitation for both groups. Finally, post-intervention assessments will be conducted, and the results will be compared and analyzed.
Participants/Inclusion and exclusion criteria: Inclusion Criteria: Diagnosis of mild cognitive impairment between the ages of 55 to 75 years. Exclusion Criteria: Presence of metal in the head and neck, and major psychiatric and neurological disorders.
Intervention groups: Intervention group: Received 12 sessions of direct stimulation along with cognitive rehabilitation using Rehacom software. Control group: Received the same intervention as the intervention group with a difference in the type of stimulation. This group received sham stimulation.
Main outcome variables: Computerized cognitive functions in MCI-related domains General cognitive performance Picture naming accuracy EEG indices

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20250410065281N1

Registration date: 2025-04-19, 1404/01/30

Registration timing: prospective

Last update: 2025-04-19, 1404/01/30

Update count: 0
Registration date: 2025-04-19, 1404/01/30

Registrant information: Name

Maedeh Shariat

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 31 3261 4520

Email address

maedehshariat@sums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2025-04-21, 1404/02/01
Expected recruitment end date: 2026-04-21, 1405/02/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Investigating the effects of transcranial direct current stimulation (tDCS) combined with computer-based cognitive rehabilitation on brain mapping and cognitive functions in individuals with amnestic mild cognitive impairment (a-MCI)

Public title: Investigating the effects of tDCS combined with computer-based cognitive rehabilitation on cognitive functions in individuals with a-MCI
Purpose: Supportive
Inclusion/Exclusion criteria: Inclusion criteria:

Individuals with a diagnosis of mild cognitive impairment between the ages of 55 and 75. Being a native Persian speaker Being right-handed Having at least a 5th-grade education Ability to collaborate in all stages of assessment, treatment, and follow-up (EEG acquisition, computerized and paper-pencil cognitive tests, rehabilitation sessions, and brain stimulation with tDCS)

Exclusion criteria:

Any uncorrectable defects in visual and auditory senses Presence of any metal implants in the head and chest History of untreated neurological disorders and history of epilepsy History of major psychiatric disorders in the past year function History of cardiovascular, respiratory, and skin diseases History of substance abuse and alcohol consumption Current use of medications affecting brain function Simultaneous participation in another study related to the nervous system and cognitive
Age: From 55 years old to 75 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Data analyser

Sample size

Target sample size: 30

Randomization (investigator's opinion)

Randomized

Randomization description

A simple randomization method is used for randomization. The tool utilized is an online randomization software. In this way, the principal investigator assigns codes from one to thirty, which are distributed into the intervention and control groups using random distribution software, to the participants in the order of their entry into the study. Thus, individuals are randomly assigned to the two groups. There is no concealment of any part of the study conducted by the principal investigator.

Blinding (investigator's opinion)

Double blinded

Blinding description

In this study, regarding the type of transcranial electrical stimulation, the participant remains uninformed, such that all procedures are conducted similarly to the intervention group, and the sham stimulation produces similar skin effects as the real stimulation. The individual performing the data analysis conducts the analysis using group codes (A and B) instead of the names of the interventions, remaining unaware of the type of intervention for each group

Placebo

Used

Assignment

Parallel

Other design features

The stimulation area with tDCS in this study is the temporal pole, and EEG data will be analyzed before and after the intervention.

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Shiraz University of Medical Sciences Ethics Committee

Street address

Central Building of Shiraz University of Medical Sciences Zand Street, Opposite Palestine Street Shiraz, Iran

City

Shiraz

Province

Fars

Postal code

71348-14336
Approval date: 2025-04-09, 1404/01/20
Ethics committee reference number: IR.SUMS.REC.1404.013

Health conditions studied

1

Description of health condition studied: Mild Cognitive Impairment
ICD-10 code: F06.7
ICD-10 code description: Mild cognitive disorder: A disorder characterized by impairment of memory, learning difficulties, and reduced ability to concentrate on a task for more than brief periods. There is often a marked feeling of mental fatigue when mental tasks are attempted,

Primary outcomes

1

Description: EEG indicators
Timepoint: Pre and post the intervention
Method of measurement: Complete tools and software for recording and analyzing electroencephalography signals

Secondary outcomes

1

Description: Cognitive performance in domains related to MCI in CANTAB
Timepoint: Pre and post the intervention
Method of measurement: Scores obtained from performing the MCI-related domains in the CANTAB Computerized Assessment Battery

2

Description: Overall cognitive performance in MoCA and Adenbrook tests
Timepoint: Pre and post the intervention
Method of measurement: Score obtained from the performance on the MoCA and Adenbrook pencil-paper tests

3

Description: Percentage of accuracy in picture naming
Timepoint: Pre and post the intervention
Method of measurement: Percentage of correctly named items in the picture naming test

Intervention groups

1

Description: Intervention Group: Each individual in this group will undergo intervention over 12 sessions during a period of 4 weeks. The intervention consists of receiving 45 minutes of cognitive rehabilitation using the RehaCom software, focusing on memory and language-related indices, along with 20 minutes of anodal-transcranial direct current stimulation (anodal-tDCS) at an intensity of 2 milliamperes applied to the left temporal pole, which begins simultaneously with the start of the rehabilitation. At the beginning of each session, the setup and connections for the electrical stimulation are made on the individual's head while they are positioned in front of a touchscreen computer. Then, after explaining what is about to happen, the stimulation begins, and simultaneously, the individual receives the various stages of cognitive rehabilitation according to the necessary instructions provided by the therapist. The difficulty level of the exercises gradually increases, based on an 80% correct response rate. After 20 minutes, the stimulation is completed, and the rehabilitation continues in the same manner.
Category: Treatment - Devices

2

Description: Control Group: Each individual in this group will undergo intervention over 12 sessions during a period of 4 weeks. The intervention includes 45 minutes of cognitive rehabilitation using the RehaCom software, focusing on memory and language-related indices, along with 20 minutes of sham transcranial direct current stimulation (sham-tDCS) that creates sensations similar to real stimulation on the left temporal pole, which is provided simultaneously with the start of the rehabilitation.At the beginning of each session, the settings and connections for the electrical stimulation are made on the individual's head, similar to real stimulation, while they are positioned in front of a touchscreen computer. Following an explanation of what is about to happen, the stimulation begins, and simultaneously, the individual receives various stages of cognitive rehabilitation based on the necessary instructions provided by the therapist. The difficulty level of the exercises gradually increases, based on an 80% correct response rate. After 20 minutes, the sham stimulation concludes, and the rehabilitation continues in the same manner.
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Isfahan Cognitive Lab

Full name of responsible person

Dr. Maahgol Tavakolli

Street address

Cognitive Laboratory, Second Floor, Faculty of Educational Sciences, University of Isfahan, University Street

City

Isfahan

Province

Isfehan

Postal code

8174673461

Phone

+98 31 3793 5462

Email

isfahancoglab@gmail.com

Web page address

https://icl.ui.ac.ir/

1

Sponsor: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Mohamadreza Nammavar

Street address

Anatomy Department, 8th Floor, Building 3, Faculty of Medicine, Zand Street

City

Shiraz

Province

Fars

Postal code

7134845794

Phone

+98 71 3230 4284

Email

namavarm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Shiraz 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

Shiraz University of Medical Sciences

Full name of responsible person

Mohamadreza Namavar

Position

Associate Professor, Department of Anatomy, Shiraz University of Medical Sciences

Latest degree

Ph.D.

Other areas of specialty/work

Neuroanatomy

Street address

Anatomy Department, 8th Floor, Building 3, Faculty of Medicine, Zand Street

City

Shiraz

Province

Fars

Postal code

7134845794

Phone

0987132304284

Email

namavarm@sums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Maedeh Shariat

Position

PhD Condidate

Latest degree

Master

Other areas of specialty/work

Neuroscience

Street address

No. 23,Next second Ave, Ferdous Street , Allameh amini Blvd

City

Isfahan

Province

Isfehan

Postal code

8158791375

Phone

+98 31 3261 4520

Fax

Email

maedehshariat@sums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Maedeh Shariat

Position

PhD Condidate

Latest degree

Master

Other areas of specialty/work

Neuroscience

Street address

No. 23,Next second Ave, Ferdous Street , Allameh amini Blvd

City

Isfahan

Province

Isfehan

Postal code

8158791375

Phone

+98 31 3261 4520

Fax

Email

maedehshariat@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be 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: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

Investigating the effects of transcranial direct current stimulation (tDCS) combined with computer-based cognitive rehabilitation on brain mapping and cognitive functions in individuals with amnestic mild cognitive impairment (a-MCI)