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

Stroke Clinical Trial

— VITAL  

Official title:

Randomized Controlled Trial To Evaluate The Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379182
• Other study ID #: VITAL
• Status: Completed
• Phase: N/A
• First received: February 27, 2015
• Last updated: August 26, 2016
• Start date: October 2014
• Est. completion date: July 2016

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deglutition Disorders
• Stroke

Intervention

Behavioral:
• standard clinical care
adaptation of fluids, diet and oral hygiene recommendations, and postural and swallowing maneuvers training if necessary

Device:
• transcutaneous electrical stimulation at sensory level
The treatment procedure will consist of the application, at rest, of 80 Hz of transcutaneous electrical stimulus (biphasic, 700 µs) using VitalStim device (Chattanooga Group, Hixson, TN, USA), 2 sessions of 1 hour per day the first week, and 1 hour per day the next week. Sessions will be applied from Monday to Friday for two weeks. Treatment intensity will be set to 75% of motor threshold and electrode placement, thyro-hyoid (placement 3a described in the VitalStim Certification Program). The motor threshold will be determined by triplicate, as the intensity level at which the patient reports a grabbing or pulling sensation and confirmed by the clinician. Every 10 min, the patient will be asked if the initial sensation is maintained and, if necessary, treatment intensity will be re-adjusted.
• transcutaneous electrical stimulation at motor level
The treatment procedure will consist of the application, at rest, of 80 Hz of transcutaneous electrical stimulus (biphasic, 700 µs) using VitalStim device (Chattanooga Group, Hixson, TN, USA), 2 sessions of 1 hour per day the first week, and 1 hour per day the next week. Sessions will be applied from Monday to Friday for two weeks. Treatment intensity will be set to the motor threshold and electrode placement, supra-hyoid. The motor threshold will be determined by triplicate, as the intensity level at which the patient reports a grabbing or pulling sensation and confirmed by the clinician. Every 10 min, the patient will be asked if the initial sensation is maintained and, if necessary, treatment intensity will be re-adjusted.

Locations

Country	Name	City	State
Spain	Hospital de Mataró	Mataró	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Pere Clave	Hospital de Granollers

Country where clinical trial is conducted

Spain, 

Outcome

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