Dysphagia After Different Swallowing Therapies

Chang Gung Medical Foundation

Status: Completed

Conditions: Dysphagia; Stroke; Videofluoroscopy

Treatments: Other: NMES therapy; Other: general swallowing therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03048916

NMRPG896021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 3 patient groups

general swallowing therapy

Other group

Description:

including: * oral exercises * tactile stimulation * compensatory techniques * swallowing maneuvers

Treatment:

Other: general swallowing therapy

the NMES therapy with VitalStim therapeutic device

Experimental group

Description:

The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS

Treatment:

Other: NMES therapy

: the combined NMES and general swallowing therapies

Active Comparator group

Treatment:

Other: NMES therapy

Other: general swallowing therapy