Dysphagia After Different Swallowing Therapies
Primary Purpose
Dysphagia, Videofluoroscopy, Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
general swallowing therapy
NMES therapy
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia focused on measuring dysphagia, stroke, magnetic resonance imaging, videofluoroscopy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Active Comparator
Arm Label
general swallowing therapy
the NMES therapy with VitalStim therapeutic device
: the combined NMES and general swallowing therapies
Arm Description
including: oral exercises tactile stimulation compensatory techniques swallowing maneuvers
The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS
Outcomes
Primary Outcome Measures
The functional oral intake scale
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.
Secondary Outcome Measures
8-point penetration-aspiration scale (PAS)
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.
11-item functional dysphagia scale (FDS)
A 11-item functional dysphagia scale (FDS) of VFS is a sensitive and specific method for quantifying swallowing function in stroke.
3-Dimensional (3D) structural MRI
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.
Function MRI
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.
Diffusion tensor imaging
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.
Full Information
NCT ID
NCT03048916
First Posted
February 5, 2017
Last Updated
February 8, 2017
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03048916
Brief Title
Dysphagia After Different Swallowing Therapies
Official Title
Acute Stroke Patients With Dysphagia After Different Swallowing Therapies: Videofluoroscopy Findings and Brain Plasticity in Magnetic Resonance Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2010 (Actual)
Primary Completion Date
July 31, 2012 (Actual)
Study Completion Date
July 31, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Videofluoroscopy, Stroke
Keywords
dysphagia, stroke, magnetic resonance imaging, videofluoroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
general swallowing therapy
Arm Type
Other
Arm Description
including:
oral exercises
tactile stimulation
compensatory techniques
swallowing maneuvers
Arm Title
the NMES therapy with VitalStim therapeutic device
Arm Type
Experimental
Arm Description
The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS
Arm Title
: the combined NMES and general swallowing therapies
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
general swallowing therapy
Intervention Description
including a session of oral exercises, tactile stimulation, compensatory techniques, swallowing maneuvers that are taught to the participants by a speech therapist.
Intervention Type
Other
Intervention Name(s)
NMES therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The functional oral intake scale
Description
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.
Time Frame
baseline (before intervention), changes from baseline FOIS at 4 weeks
Secondary Outcome Measure Information:
Title
8-point penetration-aspiration scale (PAS)
Description
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.
Time Frame
baseline (before intervention), changes from baseline PAS score at 4 weeks
Title
11-item functional dysphagia scale (FDS)
Description
A 11-item functional dysphagia scale (FDS) of VFS is a sensitive and specific method for quantifying swallowing function in stroke.
Time Frame
baseline (before intervention), changes from baseline FDS score at 4weeks
Title
3-Dimensional (3D) structural MRI
Description
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.
Time Frame
baseline (before intervention), changes from baseline result of 3-Dimensional (3D) structural MRI at 4 weeks
Title
Function MRI
Description
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.
Time Frame
baseline (before intervention), changes from baseline result of fMRI at 4 weeks
Title
Diffusion tensor imaging
Description
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.
Time Frame
baseline (before intervention), changes from baseline result of diffusion tensor imaging at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Chi Huang, Bachelor
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Dysphagia After Different Swallowing Therapies
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