Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia
Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia
Prospective, randomized, controlled, three-arm, open-label, blinded analysis. Patients
 admitted with stroke diagnosis and with suspected dysphagia that meet the initial inclusion
 and exclusion criteria will be consented into the clinical investigation. Patients who meet
 the second set of inclusion criteria (dysphagia confirmed by VFS) will be randomized to
 either active (motor or sensory) or standard treatment (control group) arms.

 Subjects included in this clinical investigation will be evaluated at screening, 1-week,
 3-months and at 12-months post treatment.

 The main aim of the study will be to assess the effect of VitalStim therapy on improving the
 safety of swallow according to the VFS, after the treatment and at 1-year follow up, on
 patients with chronic post-stroke OD.
Inclusion Criteria:

 -  Subject is over 18 years of age.

 -  Subject is suspected of having oropharyngeal dysphagia.

 -  Subject is able to comply with videofluoroscopy protocol.

 -  Subject diagnosed with stroke.

 -  Subject has no previous history of dysphagia.

 -  Subjects who are able to give voluntary, written informed consent to participate in
 the clinical investigation and from whom consent has been obtained/ or a consultee has
 consented on the subjects behalf in line with nationally agreed guidelines concerning
 adults unable to consent for themselves.

 -  Subject is not currently participating in any other interventional clinical study.

 -  Subject is able to comply with the protocol requirements

 -  Subject scores 0 or 1 on question 1a of NIHSS

 Randomization Inclusion Criteria:

 • Subject has confirmed dysphagia (PAS of 2 or more on VFS screening or pharyngeal
 residue).

 Exclusion Criteria:

 -  Subject stroke event occurred less than 3 months ago.

 -  Subject is pregnant or a nursing mother.

 -  Subject, in the opinion of the investigator, has advanced dementia

 -  Subject fitted with a pacemaker or implantable cardiac defibrillator

 -  Subject is dysphagic from conditions other than stroke

 -  Subject has been diagnosed with a progressive neurological disorder, such as
 Parkinson's disease or Multiple Sclerosis.

 -  Subject with active neoplasm or infection process.