Prospective

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

曾接受放射治療的頭頸腫瘤患者的電生理吞嚥測試

Yes

2016-03-14

Joint CUHK-NTEC Clinical Research Ethics Committee

2016.088

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

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.

No