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IRCT20200520047521N1 IRCT 2020-10-30 Kerman University of Medical Sciences Effectiveness of transcranial direct current stimulation (TDCS) in the patients with post – stroke dysphagia Investigating the effectiveness of transcranial direct current stimulation (TDCS) on the swallowing function of the patients with post – stroke dysphagia 2020-11-20 anticipated 48 Complete https://irct.ir/trial/51098 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified randomisation using permuted blocked randomisation in each group. With random allocation software. Severity of dysphagia and severity of stroke will be used for grouping. Using sealed envelopes by a secretary for concealment, Blinding description: Blinding participants/ families/ caregivers: All participants will receive behavioral swallowing therapy and TDCS stimulation. For the sham group (control group) the same montage of TDCS will be performed. The only difference is that the real group (experimental group) will receive 20 minutes of TDCS stimulation while the sham group will receive the current only for 30 seconds at the begining and the end of the period . Blinding care providers (speech therapist, and stroke physicians), investigators and outcome assessor: The TDCS technician will be trained and employed to deliver the TDCS . The technician will be independent of the investigators and will be unaware of the study’ methodology. The secretary will inform them about the group of the patients (real or sham TDCS) in a sealed envelope. Therefore, the only persons who will know the group of the patients (sham or real) will be the secretary and the technician of TDCS. N/A DYSPHAGIA POST- STROKE. Intervention 1: Intervention group: TDCS online with classic (behavioral) swallowing therapy for 20 minutes in five therapy sessions (1 session each day). Intervention 2: Control group: Sham TDCS online with classic (behavioural) swallowing therapy for 20 minutes in five therapy sessions (1 session each day). Yes - There is a plan to make this available What will be shared: All participant data will be shared after the encoding including age, sex, dysphagia severity, test results and research implementation method. When: Six month after publication the results will be shared. To whom: All researchers. Conditions: To use in meta- analysis studies or citation data in other relevant studies. Where to obtain: Sima Farpour email: sima.farpour@gmail.com Mobile: 0098 9173177636 How to obtain: By formal request via email and the purpose of using data, the information will be sent. Comments:
public Sima Farpour
Elahiye building, Shahis Shekooh Ave, Shahid Fatemifar St, Farhangshahr Blv.
SHIRAZ Iran (Islamic Republic of) 7184839363 +98 71 3639 9507 sima.farpour@gmail.com Kerman University of Medical Sciences scientific Sima Farpour
Elahiye building, shahis shekooh st, shahid Fatemifar St, Farhangshahr Blv.
Shiraz Iran (Islamic Republic of) 7184839363 +98 71 3639 9507 sima.farpour@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 years or over. Presence of ischemic stroke confirmed with brain imaging. diagnosis of dysphagia according to Northwestern Dysphagia Patient Checksheet Screening tool (NDPCS). 18 years no limit Both Hemorrhagic or Lacunar stroke. Previous history of dysphagia. Presence of neurological disorders other than stroke or neurodegenerative disorders. Auditory and Visual Condition interfering with a speech therapist or assessor orTDCS technician s instruction History of seizures. Those with a cardiac pacemaker or metallic implants. Previous history of skull surgery or current need of skull surgery. Presence of a tracheal cannula. Unstable medical condition which can interfere with the study process (such as hemodynamic instability, decreased level of consciousness, etc.) Inability to stay alert during the treatment. This study was done during the COVID- 19 pandemic. For the safety of both patients and the research group, none of the patients recruited for the study had active SARS- COV- 2 infections or a history of infection in the last 14 days. R13 Aphagia and dysphagia Rehabilitation Rehabilitation Intervention group: TDCS online with classic (behavioral) swallowing therapy for 20 minutes in five therapy sessions (1 session each day) Control group: Sham TDCS online with classic (behavioural) swallowing therapy for 20 minutes in five therapy sessions (1 session each day) The feeding status of the patient with the Functional Oral Intake Scale (FOIS). Timepoint: before intervention, one day after the last day of intervention, one month after intervention. Method of measurement: Functional Oral Intake Scale (FOIS). The severity of dysphagia and aspiration. Timepoint: before intervention, one day after the last day of intervention, one month after intervention. Method of measurement: The MANN assessment of swallowing ability (MASA). Kerman University of Medical Sciences Approved 2020-09-07 Ethics committee of Kerman University of Medical Sciences Kerman neuroscience research center, No.1 Alley, Jahad Ave., Somayye crossroad Kerman Kerman Iran (Islamic Republic of)