Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Chronic Obstructive Pulmonary Disease Patients

Summary

This is an early feasibility study to investigate whether transcutaneous electrical stimulation applied to the abdominal wall muscles synchronous with voluntary exhalation can be used to support ventilation and affect hyperinflation in patients with chronic obstructive pulmonary disease. As part of this study, the effect of a range of stimulation intensities and stimulation timing profiles will be explored.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

DEVICE

Abdominal Stimulation - low / early

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at low stimulation current for the first half of exhalation

DEVICE

Abdominal stimulation - low/late

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at low stimulation current for the second half of exhalation

DEVICE

Abdominal Stimulation - low/full

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at low stimulation current throughout exhalation

DEVICE

Abdominal stimulation - med/early

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at medium stimulation current for the first half of exhalation

DEVICE

Abdominal stimulation - med/late

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at medium stimulation current for the second half of exhalation

DEVICE

Abdominal Stimulation - med/full

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at medium stimulation current throughout exhalation

DEVICE

Abdominal Stimulation - high/early

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at high stimulation current for the first half of exhalation

DEVICE

Abdominal Stimulation - high/late

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at hig stimulation current for the second half of exhalation

DEVICE

Abdominal Stimulation - high/full

Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation. Stimulation is applied at high stimulation current throughout exhalation

Sponsors & Collaborators

• Liberate Medical

  lead INDUSTRY

Principal Investigators

• Rodney Folz, PhD · University of Louisville

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2014-01-31

Completion

2014-01-31

FDA Device

Yes

Countries

• United States

Study Locations