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IRCT20170423033606N3 IRCT 2018-11-25 Cognitive Sciences & Technologies Council The effect of Prism Adaption and the Trans-cranial Magnetic Stimulation in spatial neglect treatment cognitive rehabilitation Trans-cranial Magnetic Stimulation (TMS) Prism Adaption (PA) Comparison of the effectiveness of cognitive rehabilitation of stroke patients with spatial neglect using the Prism Adaption and combined Prism Adaption and the Trans-cranial Magnetic Stimulation: a randomized control clinical trial 2017-07-22 anticipated 18 Complete https://irct.ir/trial/25878 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be assigned to one of two groups with the help of random numbers table, Blinding description: After randomization, intervention group patients will receive trans cranial magnetic stimulation (TMS) with the following protocol: 801 pulses will be delivered in 267 bursts and each burst consisted of 3 pulses at 30 Hz. Each session of stimulation will last 45 seconds as stimulation bursts will be delivered at 6 Hz. Magnetic coil will be tangentially placed at P3, with the handle pointing posterior. Sham group patients will receive the same stimulation protocol and the magnetic coil will be placed at P3. The only difference will be holding the magnetic coil vertical to the scalp that will resulted in no brain stimulation during the stimulation period. However, patients will hear magnetic pulses' sounds (clicks) without receiving any stimulation. 2-3 Stroke with unilateral spatial neglect. Intervention 1: Intervention group: In each session, patients will receive trans cranial magnetic stimulation (TMS). Inhibitory TMS will be as following protocol: 801 pulses will be delivered in 267 bursts and each burst will consist of 3 pulses at 30 Hz. Each session of stimulation will last 45 seconds as stimulation bursts will deliver at 6 Hz. Magnetic coil will place tangentially at P3 and the coil handle will be placed in posterior. After stimulation, patients will receive mirror therapy for 20 minutes while will wear prism glasses. Prism adaption glasses will deviate the visual fields 10 degrees to the right. In each 20 minutes of mirror therapy, patients will sit at a table containing a vertical mirror with the size of 35*35*30 cm. Patients will be asked to put their pare tic hands inside the mirror box and their intact hand in front, so mirror image of the intact hand will seem as the pare tic hand in the patients' eyes. Then, patients will open and close their hands and fingers while will look at their hands' images in the mirror. Also, they will try to do the same movements with their pare tic hands meanwhile. This therapy will continue for 10 daily sessions in 2 weeks. Intervention 2: Sham stimulation control group: In each session, patients will receive trans cranial magnetic stimulation (TMS). Inhibitory TMS will be as following protocol: 801 pulses will deliver in 267 bursts and each burst will consist of 3 pulses at 30 Hz. Each session of stimulation will last 45 seconds as stimulation bursts will deliver at 6 Hz. Magnetic coil will couple vertically place at P3, with the handle will be placed at posterior. After stimulation, patients will receive mirror therapy for 20 minutes while will wear prism glasses. Prism adaption glasses will deviate the visual fields 10 degrees to the right. In each 20 minutes of mirror therapy, patients will sit at a table contain a vertical mirror in size of 35*35*30 cm. Patients will ask to put their pare tic hands inside the mirror box and their intact hand in front, so mirror image of the intact hand will seem as the pare tic hand to the patients' eyes. Then, patients will open and close their hands and fingers while will look at their hands' images in the mirror. Also, they will try to do the same movements with their pare tic hands meanwhile. This therapy will be done during 10 daily sessions for 2 weeks. 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 more information
public SHole Vatanparasti
Block 16., Imam Hossein university., Shahid Babai Street
Tehran Iran (Islamic Republic of) 5716847146 +98 214433839881 sholevatanparast100@gmail.com Shahid Beheshti University of Medical Sciences scientific SHole Vatanparasti
Block 16., Imam Hossein university., Shahid Babai Street
Tehran Iran (Islamic Republic of) 5716847146 +98 214433839881 sholevatanparast100@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The right-handed patients stroke in right hemisphere with unilateral neglect 18 years 80 years Both Minimum age 18 and Maximum age 80 years intense pain cerebral edema brain trauma pacemaker of heart National Institutes of Health Stroke scale I64 Stroke, not specified as hemorrhage or infarction Rehabilitation Rehabilitation Intervention group: In each session, patients will receive trans cranial magnetic stimulation (TMS). Inhibitory TMS will be as following protocol: 801 pulses will be delivered in 267 bursts and each burst will consist of 3 pulses at 30 Hz. Each session of stimulation will last 45 seconds as stimulation bursts will deliver at 6 Hz. Magnetic coil will place tangentially at P3 and the coil handle will be placed in posterior. After stimulation, patients will receive mirror therapy for 20 minutes while will wear prism glasses. Prism adaption glasses will deviate the visual fields 10 degrees to the right. In each 20 minutes of mirror therapy, patients will sit at a table containing a vertical mirror with the size of 35*35*30 cm. Patients will be asked to put their pare tic hands inside the mirror box and their intact hand in front, so mirror image of the intact hand will seem as the pare tic hand in the patients' eyes. Then, patients will open and close their hands and fingers while will look at their hands' images in the mirror. Also, they will try to do the same movements with their pare tic hands meanwhile. This therapy will continue for 10 daily sessions in 2 weeks. Sham stimulation control group: In each session, patients will receive trans cranial magnetic stimulation (TMS). Inhibitory TMS will be as following protocol: 801 pulses will deliver in 267 bursts and each burst will consist of 3 pulses at 30 Hz. Each session of stimulation will last 45 seconds as stimulation bursts will deliver at 6 Hz. Magnetic coil will couple vertically place at P3, with the handle will be placed at posterior. After stimulation, patients will receive mirror therapy for 20 minutes while will wear prism glasses. Prism adaption glasses will deviate the visual fields 10 degrees to the right. In each 20 minutes of mirror therapy, patients will sit at a table contain a vertical mirror in size of 35*35*30 cm. Patients will ask to put their pare tic hands inside the mirror box and their intact hand in front, so mirror image of the intact hand will seem as the pare tic hand to the patients' eyes. Then, patients will open and close their hands and fingers while will look at their hands' images in the mirror. Also, they will try to do the same movements with their pare tic hands meanwhile. This therapy will be done during 10 daily sessions for 2 weeks. Unilateral neglect. Timepoint: Before and after 10 session treatment. Method of measurement: Line Bisection Test; Star Cancellation Test; The Catherine Bergego Scale. Neurological function. Timepoint: Before and after 10 session treatment. Method of measurement: The Modified Rankin Scale and The Barthel Index Scale. Writing errors of unilateral neglect. Timepoint: Before and after 10 session treatment. Method of measurement: The Writing Test. Painting of unilateral neglect. Timepoint: Before and after 10 session treatment. Method of measurement: The Painting Coloring Test. Reading of unilateral neglect. Timepoint: Before and after 10 session treatment. Method of measurement: The Reading Test. Copying shape of unilateral neglect. Timepoint: Before and after 10 session treatment. Method of measurement: The O’clock Test and The Copying Shape. Aphasia of unilateral neglect:;. Timepoint: Before and after 10 session treatment:;. Method of measurement: Persian Diagnostic Aphasia Battery-Aphasia Quotient Test,Persian Picture Naming Battery Test, Picture Naming. Memory of unilateral neglect. Timepoint: Before and after 10 session treatment. Method of measurement: Wechsler Memory Scale: Sub Test, River Mill Scale: Sub Test, Rey Auditory Verbal Learning Test. Spatial ability unilateral neglect. Timepoint: Before and after 10 session treatment. Method of measurement: Mental Rotation Test,Visualizing Test and Water Level Test. Cognitive Sciences & Technologies Council Approved 2017-05-13 Ethics committee of Iran University of Medical Sciences Between Sheikh Fazlollah Noori and Shahid Chamran highway, Shahid Hemmat high way Tehran Tehran Iran (Islamic Republic of)