Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia "VITAL"

Completed

Phase N/A Results N/A

Eligibility Criteria

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.