Stroke Clinical Trial
— VITALOfficial title:
Randomized Controlled Trial To Evaluate The Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia
Verified date | August 2016 |
Source | Hospital de Mataró |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Comité Ético de Investigación Clínica |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de Mataró | Mataró | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Pere Clave | Hospital de Granollers |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Penetration-Aspiration scores | baseline and Post-treatment visit (5 days) | No | |
Primary | Change in Penetration-Aspiration scores | baseline and 1 year | No | |
Secondary | Incidence of all adverse events | 1 year | Yes | |
Secondary | Change in pharyngeal residue prevalence | Post-treatment visit (5 days) | No | |
Secondary | Change in pharyngeal residue prevalence | 1 year | No | |
Secondary | Change in EAT-10 scores | Post-treatment visit (5 days) | No | |
Secondary | Change in EAT-10 scores | 1 year | No | |
Secondary | Frequency of chest infections | 1 year | No | |
Secondary | Time from randomisation to death | 1 year | No |
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