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

Primary Purpose

Deglutition Disorders, Stroke

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
standard clinical care
transcutaneous electrical stimulation at sensory level
transcutaneous electrical stimulation at motor level
Sponsored by
Pere Clave
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deglutition Disorders focused on measuring dysphagia, VitalStim, electrical stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Mataró

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control group

Sensory Group

Motor Group

Arm Description

Will not receive any treatment procedure. Patients allocated in the control group will be treated according to the standard clinical care of patients with dysphagia at our center, that includes: adaptation of fluids, diet and oral hygiene recommendations, and postural and swallowing maneuvers training if necessary.

Patients allocated in the sensory group will be treated with transcutaneous electrical stimulation at sensory level. In addition, they will receive the standard clinical care described in the control group. 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 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.

Patients allocated in the motor group will be treated with transcutaneous electrical stimulation at motor level. In addition, they will receive the standard clinical care of patients with dysphagia described in the control group. 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.

Outcomes

Primary Outcome Measures

Change in Penetration-Aspiration scores
Change in Penetration-Aspiration scores

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2015
Last Updated
August 26, 2016
Sponsor
Pere Clave
Collaborators
Hospital de Granollers
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1. Study Identification

Unique Protocol Identification Number
NCT02379182
Brief Title
Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia
Acronym
VITAL
Official Title
Randomized Controlled Trial To Evaluate The Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pere Clave
Collaborators
Hospital de Granollers

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition Disorders, Stroke
Keywords
dysphagia, VitalStim, electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Will not receive any treatment procedure. Patients allocated in the control group will be treated according to the standard clinical care of patients with dysphagia at our center, that includes: adaptation of fluids, diet and oral hygiene recommendations, and postural and swallowing maneuvers training if necessary.
Arm Title
Sensory Group
Arm Type
Experimental
Arm Description
Patients allocated in the sensory group will be treated with transcutaneous electrical stimulation at sensory level. In addition, they will receive the standard clinical care described in the control group. 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 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.
Arm Title
Motor Group
Arm Type
Experimental
Arm Description
Patients allocated in the motor group will be treated with transcutaneous electrical stimulation at motor level. In addition, they will receive the standard clinical care of patients with dysphagia described in the control group. 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.
Intervention Type
Behavioral
Intervention Name(s)
standard clinical care
Intervention Description
adaptation of fluids, diet and oral hygiene recommendations, and postural and swallowing maneuvers training if necessary
Intervention Type
Device
Intervention Name(s)
transcutaneous electrical stimulation at sensory level
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
transcutaneous electrical stimulation at motor level
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Penetration-Aspiration scores
Time Frame
baseline and Post-treatment visit (5 days)
Title
Change in Penetration-Aspiration scores
Time Frame
baseline and 1 year
Secondary Outcome Measure Information:
Title
Incidence of all adverse events
Time Frame
1 year
Title
Change in pharyngeal residue prevalence
Time Frame
Post-treatment visit (5 days)
Title
Change in pharyngeal residue prevalence
Time Frame
1 year
Title
Change in EAT-10 scores
Time Frame
Post-treatment visit (5 days)
Title
Change in EAT-10 scores
Time Frame
1 year
Title
Frequency of chest infections
Time Frame
1 year
Title
Time from randomisation to death
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital de Mataró
City
Mataró
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain

12. IPD Sharing Statement

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

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