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IRCT20201016049041N1 IRCT 2020-10-28 Shahid Beheshti University of Medical Sciences The Effect of rTMS on stroke The Effect of rTMS on working memory of patient with stroke 2020-11-05 anticipated 32 Complete https://irct.ir/trial/51693 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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. N/A stroke. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information available
public Dr. Minoo Kalantari
Faculty of Rehabilitation Sciences. in front of Bouali Hospital - Damavand St., Tehran
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7754 2057 rehab@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dr. Minoo Kalantari
Faculty of Rehabilitation Sciences. in front of Bouali Hospital - Damavand St., Tehran
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7754 2057 rehab@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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. 55 years 75 years Both G46.4 Cerebellar stroke syndrome Rehabilitation Rehabilitation 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. 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. 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. Shahid Beheshti University of Medical Sciences Approved 2020-06-28 Ethics Committee of Shahid Beheshti University of Medical Sciences Shahid Chamran Highway Yemen St. - Shahid Arabi St. next to Ayatollah Taleghani Hospital, Tehran Tehran Tehran Iran (Islamic Republic of)