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PhEAST trial – Pharyngeal Electrical Stimulation for Acute Stroke dysphagia Trial

Trial documents

SA-06-22

 

SA-06-22

The main changes in this amendment are changes to the inclusion / exclusion criteria, comprising of:
  1. Inclusion criteria updated to state FOIS score of:  or 3 if 14-31 days post stroke (tube dependent with consistent oral intake of food or liquids)
  2. Exclusion criteria updated to state:  Ongoing treatment of dysphagia with other forms of electrical / magnetic stimulation e.g. NMES, TCDS, rTMS,  Pacemaker, cochlear implant or implantable cardioverter-defibrillator, palliative care.
There are then a number of additional wording changes throughout the protocol for clarification.
  1. The consultee information sheet has had a typographical error changed.
  2. The postal follow up form (day 90, 180 and day 365) has been updated to correspond with the E-CRF.
  3. We have introduced an IQCODE postal form for informants to complete.



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