Evaluation of Thermal-Aided Muscle Stimulation

July 26, 2013 updated by: Niveus Medical, Inc.
An investigation into the relative effectiveness of thermal-aided muscle stimulation vs. body temperature muscle stimulation for eliciting muscle contraction in the quadriceps

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

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 Contact

Study Locations

  • United States
    • California
      • Mountain View, California, United States, 94040
        • Recruiting
        • Melchor Pavilion
        • Contact:
          • Bahman Nouri, MD
          • Phone Number: 650-962-4690
        • Principal Investigator:
          • Bahman Nouri, MD

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

Yes

Genders Eligible for Study

All

Description

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 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: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Device: Thermal-aided muscle stimulation
Thermal-aided muscle stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110
ACTIVE_COMPARATOR: Body Temperature Control
Stimulation performed with body temperature control
Device: Body Temperature Stimulation
Body temperature stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Contraction Force
Time Frame: At 30 s intervals for 20 minutes
Measured in Newtons
At 30 s intervals for 20 minutes

Collaborators and Investigators

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

Sponsor

Niveus Medical, Inc.

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

July 1, 2013

Primary Completion (ANTICIPATED)

September 1, 2013

Study Registration Dates

First Submitted

July 12, 2013

First Submitted That Met QC Criteria

July 26, 2013

First Posted (ESTIMATE)

July 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2013

Last Update Submitted That Met QC Criteria

July 26, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP3.00

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.

Clinical Trials on Atrophy

Clinical Trials on Thermal-aided muscle stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe