Clinical trial NCT02379182: Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia
Official title: Randomized Controlled Trial To Evaluate The Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deglutition Disorders
Stroke
Keywords: dysphagia
VitalStim
electrical stimulation
Lead sponsor: Hospital de Mataró
Sponsor class: OTHER
Collaborators: name: Hospital de Granollers
First posted: 2015-03-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Penetration-Aspiration scores
timeFrame: baseline and Post-treatment visit (5 days)
measure: Change in Penetration-Aspiration scores
timeFrame: baseline and 1 year
Secondary outcomes:
measure: Incidence of all adverse events
timeFrame: 1 year
measure: Change in pharyngeal residue prevalence
timeFrame: Post-treatment visit (5 days)
measure: Change in pharyngeal residue prevalence
timeFrame: 1 year
measure: Change in EAT-10 scores
timeFrame: Post-treatment visit (5 days)
measure: Change in EAT-10 scores
timeFrame: 1 year
measure: Frequency of chest infections
timeFrame: 1 year
measure: Time from randomisation to death
timeFrame: 1 year
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
Study officials:
References: