Evaluation of Muscle Activation Efficiency in Challenging Subjects

Niveus Medical, Inc.30 enrolled

Overview

The purpose of this study is to determine whether muscle activation can be accomplished more effectively and comfortably in challenging subjects using novel configurations of an activation device. A novel device will be compared side by side with a market leading device.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity COPD

Interventions

Muscle Activation with Niveus and Intelect DevicesDEVICE

Subjects will receive muscle activation technology from the Niveus device on one leg and from the Intelect (commercially-available third-party) device on the other. The order of use and the leg applied to will be randomized.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * BMI \> 30 (Wing 1 of study) * Non-hospitalized with confirmed diagnosis of COPD (Wing 2 of study) Exclusion Criteria: * Age \< 18 years * Subject has an implanted pacemaker/defibrillator * Subject diagnosed with epilepsy * Subject has implanted metallic femoral rods * Subject is chair- or bed-bound * Subject has neuromuscular disease or abnormalities * Subject BMI \> 45 * Evidence of disease or condition that, in the opinion of the investigator, may compromise the conduct of or results of the study

Locations (1)

Fogarty Clinical Research

Mountain View, California, United States

Outcomes

Primary Outcomes

Intensity Required

Intensity required to achieve target levels of muscle contraction

Time frame: During treatment

Secondary Outcomes

Comfort

Comfort of stimulation will be assessed at various intensity levels using a widely-used discomfort scale

Time frame: During treatment

Data from ClinicalTrials.gov

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