Recruiting

Thermal-Aided Muscle Stimulation

Sponsor:

Niveus Medical, Inc.

Code:

NCT01911312

Conditions

Weakness

Atrophy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Thermal-aided muscle stimulation

Body Temperature Stimulation

Study Details

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

Conditions

Weakness

Atrophy

Study ID

NCT01911312

Start date

Jul, 2013

Status verified date

Jul, 2013

Primary completion date

Sep, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

active comparator: Body Temperature Control

Stimulation performed with body temperature control

Interventions

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

Primary outcome measure

  • Muscle Contraction Force [ Time Frame: At 30 s intervals for 20 minutes ]

Central Contacts and Locations

Central contacts

Brian Fahey, PhD

650-336-7922brian@niveusmedical.com

Locations

Melchor Pavilion

Recruiting

Mountain View, California, United States, 94040

Contacts

Bahman Nouri, MD

650-962-4690

Principal Investigator:

Bahman Nouri, MD

More Information

Sponsor

Niveus Medical, Inc.

Last update posted

Jul 30, 2013

Last verified

Jul, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Niveus Medical, Inc. on 2013-07-30.