Comparison of cognitive rehabilitation, Transcranial Alternating Current Stimulation (tACS)، combination of cognitive rehabilitation and Transcranial Alternating Current Stimulation ,and the effect of vitamin D on cognitive and executive functions of patients with mild cognitive impairment (MCI).
Comparison of the effectiveness of cognitive rehabilitation, Transcranial Alternating Current Stimulation، combination of cognitive rehabilitation and Transcranial Alternating Current Stimulation, and the effect of vitamin D on cognition and executive functions of patients with mild cognitive impairment.
Design
Four parallel group will be randomised trail design of 32 patients with mild cognitive impairement.
Settings and conduct
The study will be conducted randomly and based on two-stage sampling on people who have mild cognitive impairment in Ayatollah Taleghani Hospital.
Participants/Inclusion and exclusion criteria
Entry criteria:
Over 60 years old.
Literacy for reading and writing.
Having mild cognitive impairment according to MMSE and Moca test.
No history of head injury.
Absence of digestive disorders.
Not having medical background.
Exit criteria:
No wanting to participate in the test and continue the treatment.
Intervention groups
Cognitive rehabilitation group (8 patients).
Transcranial Alternating Current Stimulation group (8 patients).
Combination cognitive rehabilitation and Transcranial Alternating Current Stimulation group (8patients).
Vitamin D recipient (8 patients).
Main outcome variables
The effect of cognitive rehabilitation on the executive and cognitive functions of the brain.
The effect of intermittent brain stimulation on the executive and cognitive functions of the brain.
The effect of combination of cognitive rehabilitation and intermittent brain stimulation on the executive and cognitive functions of the brain.
The effect of vitamin D on the executive and cognitive functions of the brain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230125057214N1
Registration date:2023-03-11, 1401/12/20
Registration timing:retrospective
Last update:2023-03-11, 1401/12/20
Update count:0
Registration date
2023-03-11, 1401/12/20
Registrant information
Name
Fariba Ebrahimbabaie
Name of organization / entity
Ayatollah Taleghani Hospital
Country
Iran (Islamic Republic of)
Phone
+98 912 819 9386
Email address
faribaebrahimbabaie@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-27, 1401/11/07
Expected recruitment end date
2023-01-27, 1401/11/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cognitive rehabilitation, Transcranial Alternating Current Stimulation (tACS)، combination of cognitive rehabilitation and Transcranial Alternating Current Stimulation ,and the effect of vitamin D on cognitive and executive functions of patients with mild cognitive impairment (MCI).
Public title
Investigating the effect of cognitive rehabilitation, Transcranial Alternating Current Stimulation, comibination of and cognitive rehabilitation and Transcranial Alternating Current Stimulation, and the effect of vitamin D on cognitive and executive functions.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Over 60 years old
Ability to reading and writing
Having MCI according to MMSE and MOCA
No history of head. injury
Absence of digestive disorders
Not having underlying diseases
Exclusion criteria:
Not wanting to participate in the test and continue the treatment.
Age
From 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign subjects to test groups and create balance in the samples asssigned to each group, the method of 8 random blocks will be used. The size of all the blocks will be equal and 8 subjects will be placed in each block. 8 people in the first intervention group, 8 people in the second, 8 people in the third and 8 people in the fourth intervention group. The randomization tool is the random generation software Randomalocation. In this way, the output of the software includes different modes of random order A-A, B-B, C-C and D-D. For each of the blocks, a different order will be applied to the gambling of the participants in the study groups. In this process, the order of participants based on blocks cannot be predicted.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Lorestan University of Medical Sciences.
Street address
No. 106, Kachoee Ave, Velenjak.
City
Tehran
Province
Tehran
Postal code
1983914514
Approval date
2022-09-11, 1401/06/20
Ethics committee reference number
IR.LUMS.REC.1401.136
Health conditions studied
1
Description of health condition studied
Mild cognitive impairment
ICD-10 code
F06
ICD-10 code description
Other mental disorders due to brain damage and dysfunction and to physical disease
Primary outcomes
1
Description
The percentage of people whose Montreal Cognitive Assessment scores will improve.
Timepoint
Before the start of the test, the second and fourth week and one month after the treatment.
Method of measurement
Montreal Cognitive Assessment.
2
Description
The percentage of people whose Mini-Mental State Examination scores will improve.
Timepoint
Before the start of the test, the second and fourth week and one month after the treatment.
Method of measurement
Mini-Mental State Examination.
Secondary outcomes
1
Description
The percentage of people whose Beck Depression Inventory will decrease.
Timepoint
Before the start of the test, the second and fourth week and one month after treatment
Method of measurement
Beck's Depression Inventory
Intervention groups
1
Description
Intervention group 1: The effect of ten 20- minute sessions of Transcranial Alternating Current Stimulation on executive functions of people with mild cognitive impairment
Category
Treatment - Other
2
Description
Intervention group 2: The effect of ten 20- minute sessions of cognitive rehabilitation on executive functions of people with mild cognitive impairment
Category
Treatment - Other
3
Description
Intervention group3 : Combination of ten 20- minute sessions of ranscranial Alternating Current Stimulation and cognitive rehabilitation on executive functions of people with mild cognitive impairment
Category
Treatment - Other
4
Description
Intervention group 4: The effect of one month of vitamin D consumption on executive functions of people with mild cognitive impairment