Clinical Trials Logo
  1. Home
  2. Atrophy
  3. NCT01911312
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT02781623 - Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture
Completed NCT02332343 - Sparing of the Fovea in Geographic Atrophy Progression N/A
Completed NCT02497547 - An Efficacy Study of Vagitocin in Postmenopausal Women With Symptoms of Vaginal Atrophy Phase 2
Completed NCT00566982 - A Clinical Study to Evaluate the Safety of Ospemifene Phase 3
Completed NCT01586364 - Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus Phase 3
Active, not recruiting NCT05698316 - A Collaborative Resource of Heidelberg Multimodal Imaging of Intermediate and Early Atrophic AMD Cases to Study Prediction of Disease Progression
Recruiting NCT05869812 - Influence of β-hydroxy β-methyl Butyrate (HMB)Supplementation on Post-operative Muscle Mass and Function in Female Athletes Phase 2
Completed NCT02770365 - Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy Phase 3
Completed NCT02747641 - Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects N/A
Recruiting NCT02137824 - A Modified Sinus Floor Elevation Technique - a Pilot Study on 12 Patients N/A
Completed NCT01585558 - Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus Phase 3
Completed NCT02868749 - Histology and Ultrasound Pilot Study of HA Gels Adipose Tissue N/A
Completed NCT00729469 - Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity Phase 3
Completed NCT01553773 - Postmenopausal Facial Skin After Estradiol and Genistein Topical Treatment Phase 2
Recruiting NCT02745366 - Buccal Fat Pad Derived Stem Cells With Cortical Tenting in Posterior Mandible Reconstruction Phase 1
Completed NCT00807508 - Leucine Supplementation in Elderly Men Phase 1/Phase 2
Completed NCT00744094 - Resistance Training in Elderly Phase 1/Phase 2
Completed NCT00276094 - A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women Phase 3
Terminated NCT00292916 - Effect of Whole Body Vibration on Bone and Fall Related Parameters Phase 3
Terminated NCT00267839 - Effect of Exercise on Risk-factors of Elderly Women Phase 3