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

Not Applicable

Completed

• Conditions: Deglutition Disorders; Stroke

• Registration Number: NCT02379182
• Lead Sponsor: Pere Clave

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-04
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-26
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Penetration-Aspiration scores	baseline and 1 year

Secondary Outcome Measures

Name	Time	Method
Change in pharyngeal residue prevalence	1 year
Incidence of all adverse events	1 year
Frequency of chest infections	1 year
Time from randomisation to death	1 year
Change in EAT-10 scores	1 year

Trial Locations

Locations (1)

Hospital de Mataró; 🇪🇸 Mataró, Barcelona, Spain