Evaluation of Thermal-Aided Muscle Stimulation

Not Applicable

• Conditions: Weakness; Atrophy
• Interventions: Device: Thermal-aided muscle stimulation; Device: Body Temperature Stimulation

• Registration Number: NCT01911312
• Lead Sponsor: Niveus Medical, Inc.

Brief Summary

An investigation into the relative effectiveness of thermal-aided muscle stimulation vs. body temperature muscle stimulation for eliciting muscle contraction in the quadriceps

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-07
• Study Start: 2013-07
• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-07-26
• Last Update Submitted: 2013-07-26
• Study First Posted: 2013-07-30
• Last Update Posted: 2013-07-30
• Primary Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Subject does not meet any exclusion criteria

Exclusion Criteria

• Age < 18 years
• Subject is pregnant
• 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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention	Thermal-aided muscle stimulation	-
Body Temperature Control	Body Temperature Stimulation	Stimulation performed with body temperature control

Primary Outcome Measures

Name	Time	Method
Muscle Contraction Force	At 30 s intervals for 20 minutes	Measured in Newtons

Trial Locations

Locations (1)

Melchor Pavilion; 🇺🇸 Mountain View, California, United States