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IRCT20250410065281N1 IRCT 2025-04-19 Shiraz University of Medical Sciences Investigating the effects of tDCS combined with computer-based cognitive rehabilitation on cognitive functions in individuals with a-MCI 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) 2025-04-21 anticipated 30 Complete https://irct.ir/trial/82823 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, 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, 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 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. N/A Mild Cognitive Impairment. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Decisions will be made after the study.
public Mohamadreza Namavar
Anatomy Department, 8th Floor, Building 3, Faculty of Medicine, Zand Street
Shiraz Iran (Islamic Republic of) 7134845794 0987132304284 namavarm@sums.ac.ir Shiraz University of Medical Sciences scientific Maedeh Shariat
No. 23,Next second Ave, Ferdous Street , Allameh amini Blvd
Isfahan Iran (Islamic Republic of) 8158791375 +98 31 3261 4520 maedehshariat@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) 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) 55 years 75 years Both 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 F06.7 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, Treatment - Devices Rehabilitation 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. 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. EEG indicators. Timepoint: Pre and post the intervention. Method of measurement: Complete tools and software for recording and analyzing electroencephalography signals. 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. 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. 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. Shiraz University of Medical Sciences Approved 2025-04-09 Shiraz University of Medical Sciences Ethics Committee Central Building of Shiraz University of Medical Sciences Zand Street, Opposite Palestine Street Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)