BION Treatment of Dysphagia After Radical Head-Neck Surgery

NCT00628485 | Completed Phase 1

• 1 other identifier: BT9
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysphagia

Keywords

swallowing function; neuromuscular stimulator

Outcome Measures

Primary Outcomes (1)

• swallowing function

  prior surgery, 2w post surgery, end of radiation recovery, end of rehab

Secondary Outcomes (1)

• blood test, ease of swallowing questionnaire

  prior surgery, 2w post surgery, end of radiation recovery, end of rahab

Study Arms (3)

Low Stimulation

EXPERIMENTAL

The first group will have a stimulation paradigm employing low-frequency (1-5 pps), supramaximal "twitch" stimulation.

Device: BION

High Stimulation

EXPERIMENTAL

The second group will have a "High Stimulation" paradigm at a frequency that produces strong, fused contractions (20-30pps) for a total of 1h/d, also in two spaced sessions.

Device: BION

Control Group

PLACEBO COMPARATOR

A third group of experimental subjects will have a standardized program of voluntary swallowing exercises.

Device: BION

Interventions

BION DEVICE

The second group will have a "High Stimulation" paradigm at a frequency that produces strong, fused contractions (20-30pps) for a total of 1h/d, also in two spaced sessions. Stimulation intensity will be adjusted to produce the strongest contractions that are tolerated.

High Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

USC University Hospitals

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Gerald Loeb, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2008
• First Posted: March 5, 2008
• Study Start: October 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

US (1)