The effect of rTMS on working memory of people with stroke
Design
Sampling by available method of clients and individuals based on gender is divided into two groups of men and women. They were randomly divided into two groups of intervention and control. If there is no significant difference in age and Wechsler score, the intervention begins.
Settings and conduct
At the site of the Qasr Rehabilitation Clinic, an initial N-Back test is taken from all individuals by those who are unaware of the groupings (first blindness). Then everyone attends the RTMS sessions. In the control group, changing the angle of the coil will prevent the waves from reaching the brain, and thus the second blinding will occur.
In addition, everyone will receive computer-based cognitive therapy services with Captain Log software.
Finally, all the n-back tests are taken
Participants/Inclusion and exclusion criteria
1. Having a stroke for the first time
2. Age between 55 and 75
3. A minimum of 6 months and a maximum of 2 years have elapsed since the stroke
4. Lesion on the left side of the brain
5. The right side of the body dominates
6. Absence of obvious symptoms of psychosis
7- No history of seizures in the last 6 months
8. Do not take drugs that affect cognition
9 - Minimum literacy
10- Obtaining the average raw score of 2.8 حاف digits of memory, in the working memory subscale in Wechsler intelligence test
11- Not receiving TMS services before entering the study
Intervention groups
The intervention group will receive standard therapies, including occupational therapy and physiotherapy using RTMS, and the control group will receive only standard treatments. Both groups will also receive cognitive rehabilitation treatment.
Main outcome variables
Increase the quality of life
Improve working memory
Accelerate the process of cognitive therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201016049041N1
Registration date:2020-10-28, 1399/08/07
Registration timing:prospective
Last update:2020-10-28, 1399/08/07
Update count:0
Registration date
2020-10-28, 1399/08/07
Registrant information
Name
Yaser Farahmandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 2578
Email address
yaser.ot91@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-05, 1399/08/15
Expected recruitment end date
2020-12-12, 1399/09/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of rTMS on working memory of patient with stroke
Public title
The Effect of rTMS on stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a stroke for the first time based on the available medical records.
Age between 55 to 75 years of patients
At least 6 months and at most 2 years after the stroke
The lesion is on the left side of the brain.
The right side of the body should be dominant.
No obvious symptoms of psychosis in a person (according to the doctor's diagnosis)
No history of seizures in the last 6 months
Do not use drugs that affect cognition
Having a minimum literacy of reading and writing
Obtaining the average raw score of 5 digits of memory, in the working memory subscale in Wechsler intelligence test
Not receiving TMS services before entering the study
Favorable opinion of caregivers and patients based on participating in the research.
Exclusion criteria:
Age
From 55 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the double-blindness of the study, a person other than the researcher, as an assessor who is also proficient in taking the Wechsler test, completes the consent form, demographic questionnaire and also the software version of the adult Wechsler working memory test.
From the beginning of the evaluation and intervention process, the researcher is unaware of which group is the intervention or control group. The subjects do not know which of these two groups they belong to.
Both groups will receive cognitive rehabilitation intervention and TMS. The control group TMS will have the same conditions as active TMS. The difference is that changing the angle of the coil will prevent waves from reaching the brain, and the coil will be at a 45-degree angle to the surface of the skull. This condition gives the person a similar somatosensory sensation from the TMS, except that it will not affect the brain. The TMS will be performed by the device operator during the initial assessor's order.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Chamran Highway Yemen St. - Shahid Arabi St. next to Ayatollah Taleghani Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.277
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Working memory score in N-BACK test
Timepoint
Assessment of working memory at the beginning of the study (before the intervention) and 5 weeks after TMS
Method of measurement
N-BACK test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group receives rehabilitation services including occupational therapy and physiotherapy in cases related to physical-motor problems in the form of two sessions of physiotherapy and two sessions of occupational therapy per week. Then they participate in RTMS intervention sessions. In addition, people will receive computer-based cognitive therapy services using Captain Log software for 15 sessions three days a week for 30 to 40 minutes. This treatment will be performed for people immediately after performing RTMS. The exercises used are related to the working memory rehabilitation exercises in Captain Log software. The software exercises have three levels for three age groups of children, adolescents and adults. The treatment plan in this study is based on the use of the adult level. Each level has 15 stages and each stage takes an average of 1.5 to 3 minutes, which increases the difficulty of the exercises as the stages increase. . For example, in each exercise, step number two has more challenges than step number one of that exercise. How to perform cognitive rehabilitation of working memory in Captain Log software will be that after defining a specific profile named person, 5 specified exercises will be performed for them. In this way, after explaining how to perform each exercise and how to answer the questions of that exercise, the occupational therapist immediately performs the same exercise for the person. After answering, the software will go to the second exercise and again the occupational therapist will give the necessary explanations to perform that exercise. Depending on the amount of correct answers or the speed of the answers, the software will automatically increase the complexity of the exercises or reduce the complexity of the exercises in case of incorrect answers or low response speed. For example, a person responds correctly to the first to third exercises and makes a mistake in answering the fourth and fifth exercises. After completing five exercises, the software enters the second round of exercises again, but with the difference that in this round, for the first to third exercises, level two is performed, and for the fourth and fifth exercises, when the person's answers were incorrect, the same level Will repeat one. After the end of each session, information about the process of performing exercises for the person is stored in the software and in the next sessions, the continuation of the levels of exercises for that person can be performed. RTMS Interference: Sessions RTMS intervention is performed by the device operator, who is aware of how the intervention and control groups are classified. RTMS interventions for each patient will be 15 sessions three days a week and each session will last for 6 minutes. During each session, frequent active TMS with a frequency of 10 Hz will include 60 1-second stimuli (10 pulses) with a 5-second rest period between stimuli and a total of 600 pulses with a power of 100% of the movement threshold on the dorsultral perry. The left frontal cortex is applied. The control group TMS will have the same conditions as the active TMS. The difference is that changing the angle of the coil will prevent waves from reaching the brain, and the coil will be at a 45-degree angle to the surface of the skull. This condition gives the person a similar somatosensory sensation from TMS, except that it has no effect on the brain.
Category
Rehabilitation
2
Description
Control group: This group receives rehabilitation services including occupational therapy and physiotherapy in cases related to physical-motor problems in the form of two sessions of physiotherapy and two sessions of occupational therapy per week. Then they participate in RTMS intervention sessions. In addition, people will receive computer-based cognitive therapy services using Captain Log software for 15 sessions three days a week for 30 to 40 minutes. This treatment will be performed for people immediately after performing RTMS. The exercises used are related to the working memory rehabilitation exercises in Captain Log software. The software exercises have three levels for three age groups of children, adolescents and adults. The treatment plan in this study is based on the use of the adult level. Each level has 15 stages and each stage takes an average of 1.5 to 3 minutes, which increases the difficulty of the exercises as the stages increase. . For example, in each exercise, step number two has more challenges than step number one of that exercise. How to perform cognitive rehabilitation of working memory in Captain Log software will be that after defining a specific profile named person, 5 specified exercises will be performed for them. In this way, after explaining how to perform each exercise and how to answer the questions of that exercise, the occupational therapist immediately performs the same exercise for the person. After answering, the software will go to the second exercise and again the occupational therapist will give the necessary explanations to perform that exercise. Depending on the amount of correct answers or the speed of the answers, the software will automatically increase the complexity of the exercises or reduce the complexity of the exercises in case of incorrect answers or low response speed. For example, a person responds correctly to the first to third exercises and makes a mistake in answering the fourth and fifth exercises. After completing five exercises, the software enters the second round of exercises again, but with the difference that in this round, for the first to third exercises, level two is performed, and for the fourth and fifth exercises, when the person's answers were incorrect, the same level Will repeat one. After the end of each session, information about the process of performing exercises for the person is stored in the software and in the next sessions, the continuation of the levels of exercises for that person can be performed. RTMS Interference: Sessions RTMS intervention is performed by the device operator, who is aware of how the intervention and control groups are classified. RTMS interventions for each patient will be 15 sessions three days a week and each session will last for 6 minutes. During each session, frequent active TMS with a frequency of 10 Hz will include 60 1-second stimuli (10 pulses) with a 5-second rest period between stimuli and a total of 600 pulses with a power of 100% of the movement threshold on the dorsultral perry. The left frontal cortex is applied. The control group TMS will have the same conditions as the active TMS. The difference is that changing the angle of the coil will prevent waves from reaching the brain, and the coil will be at a 45-degree angle to the surface of the skull. This condition gives the person a similar somatosensory sensation from TMS.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Qasr Physical Medicine and Rehabilitation Clinic
Full name of responsible person
Dr Ali Farkhani
Street address
,Alley 26 (Dahesh). in front of Bank Mellat, Qasr Crossroads,Shamsabadi St.,Isfahan
City
Esfahan
Province
Isfehan
Postal code
8511223344
Phone
+98 31 3236 7465
Email
dr.farkhani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
next to Ayatollah Taleghani Hospital- Shahid Arabi St.Shahid Chamran Highway Yemen St. Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Minoo Kalantari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Faculty of Rehabilitation Sciences. in front of Bouali Hospital - Damavand St., Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
rehab@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Minoo Kalantari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Faculty of Rehabilitation Sciences. in front of Bouali Hospital - Damavand St., Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
rehab@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Minoo Kalantari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Faculty of Rehabilitation Sciences. in front of Bouali Hospital - Damavand St., Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
rehab@sbmu.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
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study protocol
Informed consent form
Clinical study report
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
For all people
Under which criteria data/document could be used
No special conditions are considered
From where data/document is obtainable
They can contact the authors' emails
What processes are involved for a request to access data/document