Deglutition DisordersVITALNCT02379182
Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia
A study testing standard clinical care, transcutaneous electrical stimulation at sensory level and transcutaneous electrical stimulation at motor level in people with Deglutition Disorders and Stroke, run by Pere Clave at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deglutition Disorders, Stroke
- What is being tested?
- standard clinical care, transcutaneous electrical stimulation at sensory level and transcutaneous electrical stimulation at motor level
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial To Evaluate The Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia
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.
- Conditions
- Deglutition Disorders, Stroke
- Being tested
- standard clinical care, transcutaneous electrical stimulation at sensory level, transcutaneous electrical stimulation at motor level
- Keywords
- dysphagia, VitalStim, electrical stimulation
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard clinical careBehavioural
adaptation of fluids, diet and oral hygiene recommendations, and postural and swallowing maneuvers training if necessary
transcutaneous electrical stimulation at sensory levelDevice
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 levelDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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. Receives: Behavioral: standard clinical care |
| Sensory Group | Experimental | 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. Receives: Behavioral: standard clinical care; Device: transcutaneous electrical stimulation at sensory level |
| Motor Group | Experimental | 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. Receives: Behavioral: standard clinical care; Device: transcutaneous electrical stimulation at motor level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Penetration-Aspiration scores
Measured: baseline and Post-treatment visit (5 days)
Change in Penetration-Aspiration scores
Measured: baseline and 1 year
Secondary outcomes (7)
Incidence of all adverse events
Measured: 1 year
Change in pharyngeal residue prevalence
Measured: Post-treatment visit (5 days)
Change in pharyngeal residue prevalence
Measured: 1 year
Change in EAT-10 scores
Measured: Post-treatment visit (5 days)
Change in EAT-10 scores
Measured: 1 year
Frequency of chest infections
Measured: 1 year
Time from randomisation to death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pere Clave
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Granollers
- Responsible party
- Sponsor-investigator, Pere Clave, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379182
- Sponsor's protocol ID
- VITAL
- Acronym
- VITAL
- Status last verified
- Aug 2016
- First submitted
- 27 Feb 2015
- Last updated
- 29 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial To Evaluate The Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia
- ClinicalTrials.gov ID
- NCT02379182
- Acronym / sponsor ID
- VITAL / VITAL
- Conditions
- Deglutition Disorders, Stroke
- Keywords
- dysphagia, VitalStim, electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Pere ClaveUniversity, hospital or other
- Collaborators
- Hospital de Granollers
- Study start
- Oct 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: standard clinical careWill 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. |
| Sensory Group | Experimental | Behavioral: standard clinical care, Device: transcutaneous electrical stimulation at sensory levelPatients 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. |
| Motor Group | Experimental | Behavioral: standard clinical care, Device: transcutaneous electrical stimulation at motor levelPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard clinical careadaptation of fluids, diet and oral hygiene recommendations, and postural and swallowing maneuvers training if necessary | Behavioural | Control group, Motor Group, Sensory Group |
| transcutaneous electrical stimulation at sensory levelThe 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. | Device | Sensory Group |
| transcutaneous electrical stimulation at motor levelThe 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. | Device | Motor Group |
Primary outcome
Change in Penetration-Aspiration scores
Time frame: baseline and Post-treatment visit (5 days)
Change in Penetration-Aspiration scores
Time frame: baseline and 1 year
7 secondary outcomes
Incidence of all adverse events
Time frame: 1 year
Change in pharyngeal residue prevalence
Time frame: Post-treatment visit (5 days)
Change in pharyngeal residue prevalence
Time frame: 1 year
Change in EAT-10 scores
Time frame: Post-treatment visit (5 days)
Change in EAT-10 scores
Time frame: 1 year
Frequency of chest infections
Time frame: 1 year
Time from randomisation to death
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard clinical care, transcutaneous electrical stimulation at sensory level and transcutaneous electrical stimulation at motor level in people with Deglutition Disorders and Stroke, run by Pere Clave at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Penetration-Aspiration scores (time frame: baseline and Post-treatment visit (5 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2016.