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IRCT20231016059737N1 IRCT 2024-02-20 Shiraz University of Medical Sciences Tdcs in frontotemporal dementia Evaluation of Transcranial Direct Current Stimulation (TDCS) effect on the cognitive symptoms of patients with frontotemporal dementia: a randomized double blind trial 2024-02-09 anticipated 30 Complete https://irct.ir/trial/73202 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: Block randomization A randomized block design is a design, in which experimental units are first organized into homogeneous blocks and then the treatments are assigned at random to these units within these blocks. The main advantage of this design is, if done properly, it provides more precise results, Blinding description: The control and intervention group patients are both blinded and none of them are told which group they are in. The intervention patients are placed with the tdcs device and have electrical activity, but for the control group, the device is placed but the electric current is not active. The clinical caregiver who is responsible for placing tdcs on the patients is also blind. The settings of the device are applied by the relevant doctor. N/A Frontotemporal dementia. Intervention 1: Intervention group:After confirming the diagnosis of the patients, the MMSE Mini-Mental State Examination test is taken from the people. The short mental state test is a test to evaluate the quality of consciousness with the diagnosis and screening of dementia, the maximum score of which is 30. People whose MMSE score is higher than 20 will enter the study. Patients are treated with anodal tDCS. In the anodal tDCS group, anodal stimulation depolarizes neurons and increases the probability of action potentials. Stimulation is done unilaterally on the dorsolateral prefrontal cortex and tDCS will be done for the patients during 5 consecutive days, before tDCS, neuropsychiatric tests including frontal assessment battery, trail making test , verbal fluency (PFT), Picture naming task (PNT), Go no-GO task (GGT),Brief test and NPI (Neuropsychiatric inventory) are performed for patients immediately after tDCS and again 1 month after tDCS. Patients will undergo a second round 2 months after the first tDCS, and those who received anodal at the beginning will now receive sham and vice versa. Intervention 2: Control group: After confirming the diagnosis of the patients, the MMSE Mental State Examination-Mini test is taken from the people. The short MMSE mental state test is a test to evaluate the quality of consciousness with the diagnosis and screening of dementia, the maximum score of which is 30. People whose MMSE score is above 20 are included in the study. Patients are treated with anodal tDCS and sham tDCS. The sham group is a general term to indicate a passive form of stimulation (eg, very brief or weak) that is used in research to control the placebo effect. Stimulation is performed unilaterally on the dorsolateral prefrontal cortex and tDCS will be performed for 5 consecutive days for the patients. Before performing tDCS, neuropsychiatric tests including frontal battery assessment,rail makimg test ,phonemic verbal fluency (PFT) ), Picture naming task (PNT), Go no-GO task (GGT), Brief test and NPI (Neuropsychiatric inventory) are performed for patients immediately after tDCS and again 1 month after tDCS. Patients will undergo a second round 2 months after the first tDCS, and those who received anodal at the beginning will now receive sham and vice versa. 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 There is no further information
public Vahid Reza Ostovan
Motahhari Clinic, Namazi sq, Zand St.
Shiraz Iran (Islamic Republic of) ۷۱۳۴۸۷۱۴۷۳۷ +98 71 3612 1065 ostovanv@gmail.com Shiraz University of Medical Sciences scientific Vahid Reza Ostovan
Motahhari Clinic, Namazi sq, Zand St.
Shiraz Iran (Islamic Republic of) ۷۱۳۴۸۷۱۴۷۳۷ +98 71 3612 1065 ostovanv@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Frontotemporal dementia MMSE more than 11 no limit no limit Both Psychiatric or neurologic disorders except FTD Epilepsy MDD Scalp or skull lesions Contraindications for mri and tdcs like such as ferromagnetic devices in skull G31.0 Frontotemporal dementia Treatment - Devices Treatment - Other Intervention group:After confirming the diagnosis of the patients, the MMSE Mini-Mental State Examination test is taken from the people. The short mental state test is a test to evaluate the quality of consciousness with the diagnosis and screening of dementia, the maximum score of which is 30. People whose MMSE score is higher than 20 will enter the study. Patients are treated with anodal tDCS. In the anodal tDCS group, anodal stimulation depolarizes neurons and increases the probability of action potentials. Stimulation is done unilaterally on the dorsolateral prefrontal cortex and tDCS will be done for the patients during 5 consecutive days, before tDCS, neuropsychiatric tests including frontal assessment battery, trail making test , verbal fluency (PFT), Picture naming task (PNT), Go no-GO task (GGT),Brief test and NPI (Neuropsychiatric inventory) are performed for patients immediately after tDCS and again 1 month after tDCS. Patients will undergo a second round 2 months after the first tDCS, and those who received anodal at the beginning will now receive sham and vice versa. Control group: After confirming the diagnosis of the patients, the MMSE Mental State Examination-Mini test is taken from the people. The short MMSE mental state test is a test to evaluate the quality of consciousness with the diagnosis and screening of dementia, the maximum score of which is 30. People whose MMSE score is above 20 are included in the study. Patients are treated with anodal tDCS and sham tDCS. The sham group is a general term to indicate a passive form of stimulation (eg, very brief or weak) that is used in research to control the placebo effect. Stimulation is performed unilaterally on the dorsolateral prefrontal cortex and tDCS will be performed for 5 consecutive days for the patients. Before performing tDCS, neuropsychiatric tests including frontal battery assessment,rail makimg test ,phonemic verbal fluency (PFT) ), Picture naming task (PNT), Go no-GO task (GGT), Brief test and NPI (Neuropsychiatric inventory) are performed for patients immediately after tDCS and again 1 month after tDCS. Patients will undergo a second round 2 months after the first tDCS, and those who received anodal at the beginning will now receive sham and vice versa. Language. Timepoint: The beginning of the study / after 5 tdcs sessions / one month later / the end of the study. Method of measurement: verbal fluency test questionnaire /frontal assesment battery questionnaire/ picture naming task questionnaire /neuropsychiatric inventory questionnaire. Psychiatric manifestation. Timepoint: The beginning of the study / after 5 tdcs sessions / one month later / the end of the study. Method of measurement: neuropsychiatricinventory-questionnaire. Behavior. Timepoint: The beginning of the study / after 5 tdcs sessions / one month later / the end of the study. Method of measurement: neuropsychiatricinventory-questionnaire. Executive function. Timepoint: The beginning of the study / after 5 tdcs sessions / one month later / the end of the study. Method of measurement: frontal assesment battery/ trail making test/ behavior rating inventory of executive function. Response inhibition. Timepoint: The beginning of the study / after 5 tdcs sessions / one month later / the end of the study. Method of measurement: go /no go task interview. Impulsiviness. Timepoint: The beginning of the study / after 5 tdcs sessions / one month later / the end of the study. Method of measurement: go /no go task interview. Shiraz University of Medical Sciences Approved 2023-05-03 Ethics committee of Shiraz University of Medical Sciences Central building of Shiraz University of Medical Sciences, Zand Street Shiraz Fars Iran (Islamic Republic of)