Evaluation of Muscle Activation Efficiency in Challenging Subjects

January 29, 2014 updated by: Niveus Medical, Inc.

Evaluation of Muscle Stimulation Efficiency in Challenging Subjects: A Pilot Study

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 Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Mountain View, California, United States, 94040
        • Fogarty Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obese
Subjects with BMI > 30
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.
Experimental: COPD
Non-hospitalized COPD patients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity Required
Time Frame: During treatment
Intensity required to achieve target levels of muscle contraction
During treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort
Time Frame: During treatment
Comfort of stimulation will be assessed at various intensity levels using a widely-used discomfort scale
During treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bahman Nouri, MD, El Camino Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 12, 2013

First Posted (Estimate)

March 14, 2013

Study Record Updates

Last Update Posted (Estimate)

January 31, 2014

Last Update Submitted That Met QC Criteria

January 29, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • CLP-2.00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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