Evaluation of Muscle Activation Efficiency in Challenging Subjects

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811446
• Other study ID #: CLP-2.00
• Status: Completed
• Phase: N/A
• First received: March 12, 2013
• Last updated: January 29, 2014
• Start date: March 2013

Study information

• Verified date: January 2014
• Source: Niveus Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Obesity

Intervention

Device:
• Muscle Activation with Niveus and Intelect Devices
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.

Locations

Country	Name	City	State
United States	Fogarty Clinical Research	Mountain View	California

Sponsors (1)

Lead Sponsor	Collaborator
Niveus Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity Required	Intensity required to achieve target levels of muscle contraction	During treatment	Yes
Secondary	Comfort	Comfort of stimulation will be assessed at various intensity levels using a widely-used discomfort scale	During treatment	No