BION Treatment of Dysphagia After Radical Head-Neck Surgery

PHASE1CompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
Dysphagia
Interventions
DEVICE

BION

"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."

DEVICE

BION

"The first group will have a stimulation paradigm employing low-frequency (1-5 pps), supramaximal twitch stimulation. The period of the stimulation will probably be short for the first sessions as the muscles gain strength and fatigue resistance, but will eventually be 60 minutes per day in two spaced sessions of about 30 minutes each."

DEVICE

BION

A third group of experimental subjects will have a standardized program of voluntary swallowing exercises. Their BIONs will not be activated until they have worsening of dysphagia, and thus are considered to have failed conventional therapy.

Trial Locations (1)

90033

USC University Hospitals, Los Angeles

All Listed Sponsors
lead

University of Southern California

OTHER

NCT00628485 - BION Treatment of Dysphagia After Radical Head-Neck Surgery | Biotech Hunter | Biotech Hunter