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IRCT20160131026279N5 IRCT 2023-06-25 Tehran University of Medical Sciences The effect of rehabilitation and non-invasive vagus nerve stimulation on the treatment of vestibular migraine Effects of non-invasive vagus nerve stimulation and vestibular rehabilitation on dizziness, and postural control in adults with vestibular migraine 2023-06-21 anticipated 28 Complete https://irct.ir/trial/70604 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: Individual random assignment to four equal groups with block randomization method using blocks of size 4; Randomization and random sequential allocation: done with Random Allocation Software;. N/A vestibular migraine. Intervention 1: Intervention group: Intervention group 1 (VR): receiving vestibular rehabilitation program (exercises including seven VOR exercises, eight static VSR exercises and five dynamic VSR exercises), every day, 4 weeks. Intervention 2: Intervention group: Intervention group 2 (nVNS): receiving non-invasive vagus nerve stimulation, each stimulation session for 30 minutes (frequency 1 Hz, duration 0.2 milliseconds and the intensity of stimulation is the strongest sensation that patients can tolerate without pain), three times a week, 12 sessions, 4 weeks. Intervention 3: Intervention group: Intervention group 3 (VR+nVNS): receiving vestibular rehabilitation exercises along with non-invasive vagus nerve stimulation, 4 weeks. Intervention 4: Intervention group: Intervention group 4 (VR+sham nVNS): receiving vestibular rehabilitation exercises along with non-invasive vagus nerve stimulation as a sham, 4 weeks. Yes - There is a plan to make this available What will be shared: Reporting as a PhD dissertation and papers When: 2025 and after To whom: All people Conditions: Dissertation: In accordance with Tehran University of Medical Sciences copyright Paper: In accordance with the journal's policies to access the published paper Where to obtain: Dissertation: The library of the School of Rehabilitation, TUMS Papers: Databases How to obtain: For the dissertation, studying in the library For papers depends on the journal's policy. Comments:
public Mansoureh Adel Ghahraman
Enghelab Ave.
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 4364 madel@tums.ac.ir Tehran University of Medical Sciences scientific Mansoureh Adel Ghahraman
Enghelab Ave.
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 4364 madel@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age range of 18-50 years, people with vestibular migraine (diagnosed by a neurologist and based on ICDH-3 guidelines) no change in preventive medications during the last 2 months and during the study, no use of suppressive medications Compensating the vestibular system with the opinion of an expert doctor related to the thesis, no history of other vestibular disorders, Meniere's disease, ear surgery, intracranial surgery, posterior circulation stroke, epilepsy, severe cardiovascular disease, severe carotid artery disease, Previous carotid artery surgery, or implanted electrical devices. no visual and motor deficit, no history of previous vestibular rehabilitation program, sufficient visual acuity to see the target point in the vHIT test. 18 years 50 years Both Use of drugs that suppress vestibular system compensation, suffering from neck pain and limited range of motion of the neck, alcohol and drug use, history of orthopedic problems in the last 6 months obvious deformity of the lower limbs such as scoliosis and kyphosis based on the observation of a physiotherapist history of rheumatic or metabolic diseases based on individual report. G43 Migraine Rehabilitation Rehabilitation Rehabilitation Rehabilitation Intervention group: Intervention group 1 (VR): receiving vestibular rehabilitation program (exercises including seven VOR exercises, eight static VSR exercises and five dynamic VSR exercises), every day, 4 weeks. Intervention group: Intervention group 2 (nVNS): receiving non-invasive vagus nerve stimulation, each stimulation session for 30 minutes (frequency 1 Hz, duration 0.2 milliseconds and the intensity of stimulation is the strongest sensation that patients can tolerate without pain), three times a week, 12 sessions, 4 weeks Intervention group: Intervention group 3 (VR+nVNS): receiving vestibular rehabilitation exercises along with non-invasive vagus nerve stimulation, 4 weeks Intervention group: Intervention group 4 (VR+sham nVNS): receiving vestibular rehabilitation exercises along with non-invasive vagus nerve stimulation as a sham, 4 weeks Dizziness Handicap Inventory score. Timepoint: Before and after intervention. Method of measurement: Dizziness Handicap Inventory. The total score of the vertigo symptom scale. Timepoint: Before and after intervention. Method of measurement: the vertigo symptom scale. Frequency of vertigo/dizziness. Timepoint: Before and after intervention. Method of measurement: vertigo/Dizziness frequency form with numbering 0-6. Vestibulo-ocular reflex gain. Timepoint: Before and after intervention. Method of measurement: video head impulse test (vHIT). Frequencyof covert and overt saccades. Timepoint: Before and after intervention. Method of measurement: video head impulse test (vHIT). Displacement of center of pressure in both anterior-posterior and medial-lateral directions. Timepoint: Before and after intervention. Method of measurement: Static posturography on force-plate and calculation with formula. Velocity of displacement of center of pressure in both anterior-posterior and medial-lateral directions. Timepoint: Before and after intervention. Method of measurement: Static posturography on force-plate and calculation with formula. Overall average velocity. Timepoint: Before and after intervention. Method of measurement: Static posturography on force-plate and calculation with formula. The area of displacement of the center of pressure. Timepoint: Before and after intervention. Method of measurement: Static posturography on force-plate and calculation with formula. Tehran University of Medical Sciences Approved 2023-02-01 Ethics committee of School of Nursing and Midwifery & Rehabilitation - Tehran University of Medical Enghelab Ave. Tehran Tehran Iran (Islamic Republic of)