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NCT01911312 Clinical Trial

Evaluation of Thermal-Aided Muscle Stimulation

Atrophy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01911312
Other study ID # CLP3.00
Secondary ID
Status Recruiting
Phase N/A
First received July 12, 2013
Last updated July 26, 2013
Start date July 2013

Study information
Verified date July 2013
Source Niveus Medical, Inc.
Contact Brian Fahey, PhD
Phone 650-336-7922
Email brian@niveusmedical.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Device:
• Thermal-aided muscle stimulation
Thermal-aided muscle stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110
• Body Temperature Stimulation
Body temperature stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110

Locations
Country Name City State
United States Melchor Pavilion 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 Muscle Contraction Force Measured in Newtons At 30 s intervals for 20 minutes
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