Clinical trial NCT03048916: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Videofluoroscopy
Stroke
Keywords: dysphagia
stroke
magnetic resonance imaging
videofluoroscopy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The functional oral intake scale
timeFrame: baseline (before intervention), changes from baseline FOIS at 4 weeks
Secondary outcomes:
measure: 8-point penetration-aspiration scale (PAS)
timeFrame: baseline (before intervention), changes from baseline PAS score at 4 weeks
measure: 11-item functional dysphagia scale (FDS)
timeFrame: baseline (before intervention), changes from baseline FDS score at 4weeks
measure: 3-Dimensional (3D) structural MRI
timeFrame: baseline (before intervention), changes from baseline result of 3-Dimensional (3D) structural MRI at 4 weeks
measure: Function MRI
timeFrame: baseline (before intervention), changes from baseline result of fMRI at 4 weeks
measure: Diffusion tensor imaging
timeFrame: baseline (before intervention), changes from baseline result of diffusion tensor imaging at 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yu Chi Huang, Bachelor
role: PRINCIPAL_INVESTIGATOR
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