NCT02379182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

February 27, 2015

Last Update Submit

August 26, 2016

Conditions

Deglutition DisordersStroke

Keywords

dysphagiaVitalStimelectrical stimulation

Outcome Measures

Primary Outcomes (2)

  • Change in Penetration-Aspiration scores

    baseline and Post-treatment visit (5 days)

  • Change in Penetration-Aspiration scores

    baseline and 1 year

Secondary Outcomes (7)

  • Incidence of all adverse events

    1 year

  • Change in pharyngeal residue prevalence

    Post-treatment visit (5 days)

  • Change in pharyngeal residue prevalence

    1 year

  • Change in EAT-10 scores

    Post-treatment visit (5 days)

  • Change in EAT-10 scores

    1 year

  • +2 more secondary outcomes

Study Arms (3)

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.

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.

Behavioral: standard clinical careDevice: 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.

Behavioral: standard clinical careDevice: transcutaneous electrical stimulation at motor level

Interventions

standard clinical careBEHAVIORAL

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

Control groupMotor GroupSensory Group
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.

Sensory Group
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.

Motor Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Subject has confirmed dysphagia (PAS of 2 or more on VFS screening or pharyngeal residue).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

Location

MeSH Terms

Conditions

Deglutition DisordersStroke

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 27, 2015

First Posted

March 4, 2015

Study Start

October 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 29, 2016

Record last verified: 2016-08

Locations

ES(1)