The effect of transcranial direct and pulsed current stimulation on motor learning and cortical activity in older adults
Design
A clinical trial with a control group, parallel groups, double-blind, randomized, 72 participants in 3 groups of 24 people.
Settings and conduct
Neuromuscular Rehabilitation Research Center Semnan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 60 to 75 years; Participants should be right-handed; Obtain a score of 21 to 24 through the memory impairment test; The minimum education is a diploma and the maximum is a master's degree.
Exclusion Criteria: History of neurological diseases such as Parkinson's, Alzheimer's, and schizophrenia; History of psychological diseases; Use of any sedative medications in the past two days; Suffering from color blindness; Movement disorders in the upper limb of the right hand.
Intervention groups
Intervention group 1:In this group, according to the protocol, the direct currents of the transcranial direct current stimulation device will be used for 20 minutes, and the intensity of 2 mA in the area of the primary motor cortex (M1).
Intervention group 2: In this group, according to the protocol, the pulse currents of the transcranial pulse current stimulation device will be used for 20 minutes, and the intensity of 2 mA with a random frequency between 6 and 10 Hz on the area of the primary motor cortex (M1).
Control group: In this group, transcranial pulsed current stimulation and direct Transcranial direct-current stimulation are randomly used, and the current is automatically cut off after 30 seconds and is only for comparison with the intervention group.
Main outcome variables
Movement learning; Implicit learning; The amount of brain activity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N79
Registration date:2023-07-30, 1402/05/08
Registration timing:prospective
Last update:2023-07-30, 1402/05/08
Update count:0
Registration date
2023-07-30, 1402/05/08
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-05, 1402/05/14
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of transcranial direct and pulsed current stimulation on motor learning and cortical activity in older adults
Public title
The effect of transcranial direct and pulsed current stimulation on motor learning and cortical activity in older adults
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 to 75 years
Participants should be right-handed
Obtaining a score of 21 to 24 through the memory impairment test
The minimum education is a diploma and the maximum is a master's degree
Exclusion criteria:
History of neurological diseases such as Parkinson's, Alzheimer's, schizophrenia
History of psychological diseases
Use of any sedative medications in the past two days
Suffering from color blindness
Movement disorders in the upper limb of the right hand
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the random block method with the size of 6 blocks; we will assign 1 to 6 for each block. Then, using the random number table, based on the sample size, 12 units of 6 blocks will be selected so that we consider having 24 people in group (A), 24 people in group (B), and 24 people in group (C). Therefore, we will do block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding of the analyst, the outcome evaluator and the participant (double-blind) is done so that the groups are defined as A, B, and C for the patients and provided to the analyst and the outcome evaluator so they do not know about the grouping method.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Dr. Mirkhani St. (East Nusrat), Tawheed Square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2023-05-29, 1402/03/08
Ethics committee reference number
IR.TUMS.FNM.REC.1402.038
Health conditions studied
1
Description of health condition studied
Movement disorder
ICD-10 code
F82
ICD-10 code description
Specific developmental disorder of motor function
Primary outcomes
1
Description
Movement learning
Timepoint
The first session, the last session and 2 weeks after the intervention
Method of measurement
The Color Matching Test (CMT) software will record and measure the time of the homework.
2
Description
Implicit learning
Timepoint
The first session, the last session and 2 weeks after the intervention
Method of measurement
The Color Matching Test (CMT) software will record and measure the time of the homework.
3
Description
The amount of brain activity
Timepoint
The first session, the last session and 2 weeks after the intervention
Method of measurement
Electroencephalography device and MATLAB and EEGLAB software are used.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:In this group, according to the protocol, the direct currents of the transcranial direct current stimulation device will be used for 20 minutes and the intensity of 2 mA in the area of the primary motor cortex (M1).
Category
Treatment - Devices
2
Description
Intervention group 2: In this group, according to the protocol, the pulse currents of the transcranial pulse current stimulation device will be used for 20 minutes and the intensity of 2 mA with a random frequency between 6 and 10 Hz on the area of the primary motor cortex (M1).
Category
Treatment - Devices
3
Description
Control group: In this group, transcranial pulsed current stimulation and direct Transcranial direct-current stimulation are randomly used, and the current is automatically cut off after 30 seconds and is only for comparison with the intervention group.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Nastaran Ghotbi
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Dalvand
Street address
Faculty of Rehabilitation, Pich Shamiran, Enghelab St., Tehran
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nastaran Ghotbi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, Pich Shamiran, Enghelab St., Tehran
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nastaran Ghotbi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, Pich Shamiran, Enghelab St., Tehran
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohaddeseh Sadat Hafez Yousefi
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, Pich Shamiran, Enghelab St., Tehran
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
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