Evaluation of Transcranial Direct Current Stimulation (TDCS) effect on the cognitive symptoms of patients with frontotemporal dementia: a randomized double blind trial
Considering the lack of effective drug treatment for the cognitive symptoms of frontotemporal dementia, by determining the effect of transcranial direct current stimulation on the cognitive symptoms of these patients, a suitable treatment method can be provided to improve the cognitive symptoms.
Design
A crossed study, double-blinded, randomised, 30 patients
Settings and conduct
The study is conducted on patients at the Faculty of Modern Medical Sciences and Technologies, which is done in the form of 5 consecutive intervention sessions and again two months later, 5 consecutive sham sessions for each patient.
The study is double-blind, in which the patients and the person conducting the psychological tests are blind.
Participants/Inclusion and exclusion criteria
Mini-Mental State Examination more than 11
Exclusion criteria: epilepsy/major depression/scalp lesions/presence of ferromagnetic device
Intervention groups
5 session of anodal tdcs for frontotemporal patients
5 sessions of sham tdcs for frontotemporal patients
Main outcome variables
language; executive function; behavior; impulsivity; Inhibition of response; psychological manifestations
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231016059737N1
Registration date:2024-02-20, 1402/12/01
Registration timing:registered_while_recruiting
Last update:2024-02-20, 1402/12/01
Update count:0
Registration date
2024-02-20, 1402/12/01
Registrant information
Name
Vahid Reza Ostovan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 1065
Email address
ostovanv@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-09, 1402/11/20
Expected recruitment end date
2024-09-10, 1403/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Transcranial Direct Current Stimulation (TDCS) effect on the cognitive symptoms of patients with frontotemporal dementia: a randomized double blind trial
Public title
Tdcs in frontotemporal dementia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Frontotemporal dementia
MMSE more than 11
Exclusion criteria:
Psychiatric or neurologic disorders except FTD
Epilepsy
MDD
Scalp or skull lesions
Contraindications for mri and tdcs like such as ferromagnetic devices in skull
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2023-05-03, 1402/02/13
Ethics committee reference number
IR.SUMS.MED.REC.1402.078
Health conditions studied
1
Description of health condition studied
Frontotemporal dementia
ICD-10 code
G31.0
ICD-10 code description
Frontotemporal dementia
Primary outcomes
1
Description
language
Timepoint
The beginning of the study / after 5 tdcs sessions / one month later / the end of the study
The beginning of the study / after 5 tdcs sessions / one month later / the end of the study
Method of measurement
neuropsychiatricinventory-questionnaire
2
Description
behavior
Timepoint
The beginning of the study / after 5 tdcs sessions / one month later / the end of the study
Method of measurement
neuropsychiatricinventory-questionnaire
3
Description
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
4
Description
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
5
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Specialty and Subspecialty Clinic
Full name of responsible person
Dr.Vahidreza Ostovan
Street address
Central building of Shiraz University of Medical Sciences,Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 917 302 0712
Email
ostovanv@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Research and Technology Deputy,7th Floor,Shiraz University of Medical Sciences Central Building,Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@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
Vahid Reza Ostovan
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Motahhari Clinic, Namazi sq, Zand St.
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۷۱۴۷۳۷
Phone
+98 71 3612 1065
Fax
Email
ostovanv@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vahid Reza Ostovan
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Motahhari Clinic, Namazi sq, Zand St.
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۷۱۴۷۳۷
Phone
+98 71 3612 1065
Fax
Email
ostovanv@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vahid Reza Ostovan
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Motahhari Clinic, Namazi sq, Zand St.
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۷۱۴۷۳۷
Phone
+98 71 3612 1065
Fax
Email
ostovanv@gmail.com
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