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Study the effects of stimulation of transcranial direct current in nocturnal sleep on the Glymphatic system in the mild cognitive impairment patients: A randomized controlled parallel clinical trial

Protocol summary

Study aim
Study the effects of stimulation of transcranial direct current in nocturnal sleep on the Glymphatic system in the mild cognitive impairment patients: A randomized controlled parallel clinical trial
Design
This randomized clinical trial design is a parallel design with a control group. In this single-blinded study, patients are unaware that they are assigned to the first, second, or control group. This randomized study with phase 2-3, will be performed on 24 patients with mild cognitive impairment. Random blocks are used for randomization and participants are assigned to three groups (two intervention groups and one control group).
Settings and conduct
This study, which will be conducted at Farabi Hospital of Kermanshah, is single-blinded. One week before the start of the test, patients are asked to go to bed at 23:00 at night and wake up at 7:00 to 8:00 in the morning. On the night of the experiment, participants in all three groups are asked to be present at the sleep clinic of Farabi Hospital at 21:00.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 55 years; Diagnosis of mild cognitive impairment based on Petersen 2004 clinical criteria; The score of mental state short test between 24 and 30 Exclusion criteria: History of central nerve diseases (such as stroke, tumor, and brain trauma, epilepsy and etc.); The presence of metal parts in the brain, skull, and anywhere else in the body; Alcohol and drug addiction
Intervention groups
The first intervention group will receive an active transcranial direct current stimulation (TDCS) overnight. The second intervention group will receive active TDCS stimulation for two consecutive nights. The control group is stimulated with sham (in which the electrodes of the TDCS device are connected according to the protocol but the device is off).
Main outcome variables
The rate of activity of the glymphatic system system

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130812014333N162
Registration date: 2021-03-17, 1399/12/27
Registration timing: prospective

Last update: 2021-03-17, 1399/12/27
Update count: 0
Registration date
2021-03-17, 1399/12/27
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effects of stimulation of transcranial direct current in nocturnal sleep on the Glymphatic system in the mild cognitive impairment patients: A randomized controlled parallel clinical trial
Public title
The effects of stimulation of transcranial direct current in nocturnal sleep on in the mild cognitive impairment patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 55 years Diagnosis of mild cognitive impairment based on Petersen 2004 clinical criteria The score of mental state short test between 24 and 30, and CDR equal to 0.5
Exclusion criteria:
History of central nerve diseases (such as stroke, tumor and brain trauma, epilepsy, psychiatric illness, etc.) The presence of metal parts in the brain, skull and anywhere else in the body Alcohol and drug addiction Use of drugs affecting the central nervous system and sleep disorders
Age
From 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Using random blocks. First, the size of each block is determined by 3, then all the triple permutations (for three interventions, for example, A, B, C) are determined. In this step we will have 6 possible permutations (ABC / ACB / BAC / BCA / CBA / CAB) for each block. Finally, 8 blocks with random permutations and in each block, 3 samples with one of the 6 possible permutations will be assigned to three groups, which in total 24 samples with the same volume will be assigned to three groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single-blinded study, patients are unaware that they will be assigned to the first, second, or control group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-01-12, 1399/10/23
Ethics committee reference number
Ir.kums.rec.1399.1036

Health conditions studied

1

Description of health condition studied
Mild cognitive disorder
ICD-10 code
F06.7
ICD-10 code description
Mild cognitive disorder

Primary outcomes

1

Description
The rate of activity of the glymphatic system
Timepoint
Before and after interventions (30 minutes after the start of the intervention)
Method of measurement
Using Tensor Diffusion Imaging (DTI)

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group will receive an active transcranial direct current stimulation (TDCS) overnight. Stimulation begins anodally at a frequency of 0.75 Hz, 4 minutes after individuals enter the second phase of nonREM sleep for the first time. A total of 5 5-minute stimuli applied at 1-minute intervals are applied.
Category
Treatment - Other

2

Description
The second intervention group will receive active transcranial direct current stimulation (TDCS) for two consecutive nights. Stimulation begins anodally at a frequency of 0.75 Hz, 4 minutes after individuals enter the second phase of nonREM sleep for the first time. A total of 5 5-minute stimuli applied at 1-minute intervals are applied.
Category
Treatment - Other

3

Description
The control group is stimulated with sham (in which the electrodes of the TDCS device are connected according to the protocol but the device is off).
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Fatemeh Haj Zeinolabedini
Street address
Farabi Hospital, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851151
Phone
+98 83 3826 1046
Email
hanie.zeinolabedini@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Haj Zeinolabedini
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
hanie.zeinolabedini@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mahmoud Amiri
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
Medical Biology Research Center, Parastar Boulevard,
City
Kermanshah
Province
Kermanshah
Postal code
6714415185
Phone
+98 83 3427 6473
Email
ma_amiri_bme@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Haj Zeinolabedini
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
hanie.zeinolabedini@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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