BION Treatment of Dysphagia After Radical Head-Neck Surgery

Completed · Phase 1

Conditions studied: Dysphagia

In brief

The primary goal of the proposed study is to improve the long-term swallowing capabilities of subjects undergoing radical or modified radical neck surgeries followed by chemoradiation therapy (CRT), by more selective stimulation of the swallowing muscles using implanted microstimulators called BIONs.

Key facts

Study ID

NCT00628485

Run by

University of Southern California

People needed

4

Starts

2007-10-01

Expected to finish

2008-12-01

Last updated by the study team

2015-06-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has Stage 3-4 cancer of the oral cavity or oropharynx with a primary tumor size of 1-6 cm (T1-T3) and neck lymph node metastases.
• Subject is above 18 years old.
• Attending physician considers the subject to be an appropriate candidate for surgery and chemoradiation therapy.
• Subject is mentally capable of understanding the goals and the application of therapy or whenever in doubt, is able to pass the Minimental State (MMSE) test.
• Subject is able to apply the therapy without help or with the help of a caregiver.
• Subject is willing and capable of giving informed consent.
• Subject is willing and capable of traveling to testing center at the necessary points in the schedule of testing.

You may not qualify if…

• Subject is pregnant, nursing, or planning to become pregnant in the next 12 months.
• Subject has an electronic implant (e.g. cardiac pacemaker, etc.).
• Subject has large metallic implant (e.g. skull plates) in the head or neck region (small metal implants, such as bone screws, metal sutures or dental parts are acceptable).
• Subject has had previous surgery or disease of the upper esophageal tract or vocal structures that have changed the normal anatomical relationships of the epiglottal region, making swallowing abnormal, or have damaged the nerves of the target muscles that control swallowing, making it difficult to stimulate the swallowing muscles effectively.
• Subject has an active immunosuppressive disorder such as AIDS that may result in muscle wasting, or has a neurological injury or disease that affects the function of the nerves or neuromuscular endplates in the throat, such as myasthenia gravis or multiple sclerosis. The subject has a significant concurrent or recently diagnosed (less than 3 months) medical condition that, in the opinion of the medical investigator, could affect the ability of the patient to tolerate or complete the study. Such conditions might include a second malignancy, heart disease or stroke.
• Subject has a major psychological disorder, such as poorly controlled schizophrenia or paranoia, that may affect the clinical interactions with the subject or result in poor compliance with the therapy.
• Subject has a significant respiratory problem such as asthma or chronic obstructive lung disease requiring regular use of inhaled or systemic corticosteroids. Subject has a tracheostomy or has had previous surgery on the trachea that has damaged the swallowing muscles or made inhalation of swallowed food more likely.
• Subject is currently enrolled in another investigational study.

Where it is running

• USC University Hospitals — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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