Dysphagia After Different Swallowing Therapies

February 8, 2017 updated by: Chang Gung Memorial Hospital

Acute Stroke Patients With Dysphagia After Different Swallowing Therapies: Videofluoroscopy Findings and Brain Plasticity in Magnetic Resonance Imaging

Dysphagia after stroke is associated to increased pulmonary complications and mortality. The swallowing therapies could decrease the pulmonary complications and improve the quality of life after stroke. The swallowing therapies include dietary modifications, thermal stimulation, compensatory positions, and oropharyngeal muscle stimulation. Most researchers used clinical assessments and videofluoroscopy to evaluate the effect of the swallowing therapies. Some authors performed functional magnetic resonance imaging (fMRI) to investigate the brain neuroactivity during swallowing with tasks in normal adults and unilateral hemispheric stroke patients. The aim of this study is to explore the effect of swallowing therapies not only in clinical swallowing function but also brain plasticity of acute stroke patients with dysphagia by videofluoroscopy and fMRI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the study, 10 healthy controls and 48 patients with a single and acute hemispheric or brain stem stroke will be enrolled. Both 24 hemispheric and 24 brain stem stroke patients will be divided into 3 groups. General swallowing therapy, oropharyngeal neuromuscular electrical stimulation (NMES), and combined general and NMES therapies will be randomly provided for the 3 groups. Each patient will receive clinical assessment of food oral intake scale, functional dysphagia scale of videofluoroscopy, and brain neuroactivity in fMRI.

The investigators hope to find the benefit of the swallowing therapies both in clinical swallowing function and in brain functional neuroactivity/reorganization after acute stroke. While comparing the 3 swallowing therapies, different functional neuroactivity may be facilitated by different swallowing therapies. Finally, the investigators could also find out the most effective swallowing therapy among the 3 therapies in acute stroke patients with dysphagia according to the findings of videofluoroscopy and fMRI.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria of normal controls:

  • normal neurological examination
  • no history of stroke
  • no active neurological disorder

Inclusion criteria of hemispheric stroke patients:

  • a single cerebral hemispheric stroke
  • swallowing difficulty: detected by bedside swallow assessment by a physician while admitting to the rehabilitation unit.

Inclusion criteria of these brain stem stroke patients:

  • a single brain stem stroke without prior stroke history
  • swallowing difficulties: detected by bedside swallow assessment by a physician while admitting to the rehabilitation unit

Exclusion criteria:

  • multiple brain lesions due to one episode of stroke
  • impaired communication ability due to cognition deficit
  • other central or peripheral neurological deficit leading to swallowing difficulty.
  • use of an electrically sensitive biomedical device (eg. cardiac pacemaker)
  • metal clip in the brain
  • pneumonia at the time of enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: general swallowing therapy

including:

  • oral exercises
  • tactile stimulation
  • compensatory techniques
  • swallowing maneuvers
Other: general swallowing therapy
including a session of oral exercises, tactile stimulation, compensatory techniques, swallowing maneuvers that are taught to the participants by a speech therapist.
EXPERIMENTAL: the NMES therapy with VitalStim therapeutic device
The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS
Other: NMES therapy
he NMES therapy with VitalStim therapeutic device will be done by one physician who is licensed practitioner and certified in use of the VitalStim device. The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS.
ACTIVE_COMPARATOR: : the combined NMES and general swallowing therapies
Other: general swallowing therapy
including a session of oral exercises, tactile stimulation, compensatory techniques, swallowing maneuvers that are taught to the participants by a speech therapist.
Other: NMES therapy
he NMES therapy with VitalStim therapeutic device will be done by one physician who is licensed practitioner and certified in use of the VitalStim device. The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The functional oral intake scale
Time Frame: baseline (before intervention), changes from baseline FOIS at 4 weeks
Clinical swallowing evaluations: The functional oral intake scale (FOIS) was reported by Crary et al. for presenting the functional oral intake of food and liquid in stroke patients. One physician who is blinded to the therapies will evaluate the FOIS for each participant before and after swallowing treatments.
baseline (before intervention), changes from baseline FOIS at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
8-point penetration-aspiration scale (PAS)
Time Frame: baseline (before intervention), changes from baseline PAS score at 4 weeks
VFS is a standard tool for swallowing disorders. A 8-point penetration-aspiration scale (PAS) is used for observing the event of penetration or aspiration on VFS.
baseline (before intervention), changes from baseline PAS score at 4 weeks
11-item functional dysphagia scale (FDS)
Time Frame: baseline (before intervention), changes from baseline FDS score at 4weeks
A 11-item functional dysphagia scale (FDS) of VFS is a sensitive and specific method for quantifying swallowing function in stroke.
baseline (before intervention), changes from baseline FDS score at 4weeks
3-Dimensional (3D) structural MRI
Time Frame: baseline (before intervention), changes from baseline result of 3-Dimensional (3D) structural MRI at 4 weeks

MR images are obtained using a 3.0-T whole body magnet with a 50- and 23-mT/m gradient strength, and an echo-planar-capable receiver (GE SIGNA EXCITE HD, GE Medical Systems, Milwaukee, US).

A 3-dimensional (3D) structural MRI is acquired for each subject using a T1-weighted gradient echo magnetization prepared rapid gradient echo sequence yielding 124 sagittal slices with a defined voxel size of 1 x 1 x 1.5 mm.
baseline (before intervention), changes from baseline result of 3-Dimensional (3D) structural MRI at 4 weeks
Function MRI
Time Frame: baseline (before intervention), changes from baseline result of fMRI at 4 weeks

MR images are obtained using a 3.0-T whole body magnet with a 50- and 23-mT/m gradient strength, and an echo-planar-capable receiver (GE SIGNA EXCITE HD, GE Medical Systems, Milwaukee, US).

The functional images are obtained using an EPI sequence with the following parameters: 33 axial slices, image resolution = 3.75*3.75*4, and TR= 2000 ms.
baseline (before intervention), changes from baseline result of fMRI at 4 weeks
Diffusion tensor imaging
Time Frame: baseline (before intervention), changes from baseline result of diffusion tensor imaging at 4 weeks

MR images are obtained using a 3.0-T whole body magnet with a 50- and 23-mT/m gradient strength, and an echo-planar-capable receiver (GE SIGNA EXCITE HD, GE Medical Systems, Milwaukee, US).

An 8 channels diffusion tensor imaging (DTI) acquisition protocol will be used to acquire high resolution DTI, i.e. 2 x 2 x 2 mm3 voxel size. With 13 diffusion encoding directions and number of average of 4, whole brain DTI and high resolution eigenvector field can be acquired within 20 mins.
baseline (before intervention), changes from baseline result of diffusion tensor imaging at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2010

Primary Completion (ACTUAL)

July 31, 2012

Study Completion (ACTUAL)

July 31, 2013

Study Registration Dates

First Submitted

February 5, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (ESTIMATE)

February 9, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRPG896021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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