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CUHK_CCRB00526
2016-09-06
Prospective
-
Department of Otorhinolaryngology, Head and Neck Surgery, CUHK
Professor Michael Tong, CUHK
N/A
Not Applicable
Karman Leung
Department of Otorhinolaryngology, Head and Neck Surgery,
6/F Lui Che Woo Clinical Sciences Building,
Prince of Wales Hospital
26321276
karmanleung@surgery.cuhk.edu.hk
Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
Hong Kong
Michael Tong
Department of Otorhinolaryngology, Head and Neck Surgery,
6/F Lui Che Woo Clinical Sciences Building,
Prince of Wales Hospital
26322628
mtong@ent.cuhk.edu.hk
Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
Hong Kong
Electrophysiological assessment of swallowing in irradiated head and neck cancer patients
Electrophysiological assessment of swallowing in irradiated head and neck cancer patients
曾接受放射治療的頭頸腫瘤患者的電生理吞嚥測試
Hong Kong
Yes
2016-03-14
Joint CUHK-NTEC Clinical Research Ethics Committee
2016.088
Dysphagia
cranial nerve palsy
irradiated head and neck cancer
Other
1.Device 2.procedure
1. High-density (HD) surface electromyography (sEMG) is used in this study to evaluate the muscular function in the pharyngeal phase of deglutition. HD sEMG is a non-invasive intervention to assess muscular activities over time, using up to 96 surface electrodes(16x6 array) to collect electrophysiological information from front neck muscles to construct HD sEMG energy maps, which provides useful information for dysphagia diagnosis.The HD-sEMG/sEMG profile and evoked potentials obtained can be used to characterise the electrophysiology of irradiated head and neck cancer patients with dysphagia and also be able to classify patterns of dysphagia with varying severities in the oral, pharyngeal or laryngeal phases with these assessment tools.
2. Hypoglossal nerve stimulation by means of submental transcutaneous stimulation & recurrent laryngeal nerve stimulation which will be done by means of percutaneous needle stimulation, both responses will be measured by EMG. Nerve conduction test results in the identification of nerve palsies.
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Fiberoptic endoscopic examination of swallowing (FEES), a conventional swallowing examination done by ENT surgeon and experienced speech therapist using a flexible video-endoscopic system and a variety of food consistencies including solid, puree, and fluid.
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For Phase 1 Study: Head and neck cancer previously received radiotherapy to the neck. Group 1 : clinical hypoglossal nerve palsy; Group 2: clinical recurrent laryngeal nerve palsy, and Group 3 neither a hypoglossal nor a recurrent laryngeal nerve palsy previously documented and a swallowing performance status scale rating of 1 and no laryngeal penetration or aspiration as observed in FEES
For Phase 2 Study: Previously received radiotherapy to the neck and who currently have symptoms of dysphagia as revealed on fiberoptic endoscopic examination of swallowing (FEES)
History of head and neck surgery
Tumour recurrence
History of neurological disease
Severe trismus
Presence of a pacemaker or cardiac defibrillator
Bleeding tendency or on anticoagulants
18
65
Both Male and Female
Observational
Non-randomized
Not Applicable
Open label
Not Applicable
Other
pilot study
To measure the sensitivity and specificity of Surface electromyography and cranial nerve conduction tests by comparing the electrophysiological findings to a conventional swallowing examination. To develop a combination of clinical electrophysiological tests, validated and utilised as clinical tool.
2016-09-15
120
Not Yet Recruiting
HD-sEMG/sEMG values
sequence to display a spatial mapping of muscle activities throughout the entire swallow process
during swallowing
evoked potential values from the nerve conduction tests
detected by EMG in µV, latency in ms and amplitude in mV, will be measured
during intentional nerve stimulation
Presence of laryngeal penetration or aspiration
Penetration-aspiration scale
during fiberoptic endoscopic examination of swallowing (FEES)
Patient’s functional swallowing ability will be scored
Swallowing Performance Status Scale (SPSS)
during fiberoptic endoscopic examination of swallowing (FEES)
2021-02-28
ChiCTR-DPC-16009189
2016-09-06
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