Skip to main content
OpenTrials
Completed

NCT Number: NCT02379182

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Deglutition Disorders Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

standard clinical care

Behavioral

adaptation of fluids, diet and oral hygiene recommendations, and postural and swallowing maneuvers training if necessary

transcutaneous electrical stimulation at sensory level

Device

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

Device

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 outcomes

  1. Change in Penetration-Aspiration scores

    Time frame: baseline and Post-treatment visit (5 days)

  2. Change in Penetration-Aspiration scores

    Time frame: baseline and 1 year

Secondary outcomes

  1. Incidence of all adverse events

    Time frame: 1 year

  2. Change in pharyngeal residue prevalence

    Time frame: Post-treatment visit (5 days)

  3. Change in pharyngeal residue prevalence

    Time frame: 1 year

  4. Change in EAT-10 scores

    Time frame: Post-treatment visit (5 days)

  5. Change in EAT-10 scores

    Time frame: 1 year

  6. Frequency of chest infections

    Time frame: 1 year

  7. Time from randomisation to death

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Pere Clave

Other

Collaborators

  • Hospital de Granollers

Registry information

Official study title

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

Acronym: VITAL

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2015
Registry last updated
Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.