Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients

Summary

The purpose of the investigation is to learn whether intense swallowing exercise or intense swallowing exercise coupled with electrical stimulation (E-Stim) helps patients who had head/neck cancer and currently have dysphagia swallow better.

Conditions

• Dysphagia

Interventions

DEVICE

Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)

NMES or Sham NMES will be paired with repeated, effortful swallowing behavior, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.

Sponsors & Collaborators

• Northwestern University

  collaborator OTHER

• Boston University

  collaborator OTHER

• University of Wisconsin, Madison

  collaborator OTHER

• New York University

  collaborator OTHER

• VA Boston Healthcare System

  collaborator FED

• Lahey Clinic

  collaborator OTHER

• Lenox Hill Hospital

  collaborator OTHER

• Beth Israel Medical Center

  collaborator OTHER

• Greater Baltimore Medical Center

  collaborator OTHER

• Henry Ford Hospital

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Boston Medical Center

  lead OTHER

Principal Investigators

• Susan Langmore, PhD,SLP,BRS · Boston University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-03-31

Primary Completion

2012-04-30

Completion

2013-05-31

Countries

• United States

Study Locations