CClinicalTrials.gg
Status unknownNCT01911312Updated Jul 30, 2013

Evaluation of Thermal-Aided Muscle Stimulation

An interventional study of Thermal-aided muscle stimulation and Body Temperature Stimulation in Weakness and Atrophy, sponsored by Niveus Medical, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-30.

Sponsored by Niveus Medical, Inc. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Weakness
  • Atrophy

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03

In context

Atrophy

828 studies on the registry are indexed under Atrophy; 122 are open to participants now.

This study's planned enrollment of 20 is below the median of 34 across 603 interventional studies indexed under Atrophy.

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Lead sponsor

Niveus Medical, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subject does not meet any exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Intervention

    Device: Thermal-aided muscle stimulation

  • Active comparator
    Body Temperature Control

    Stimulation performed with body temperature control

    Device: Body Temperature Stimulation

Interventions

  • DeviceThermal-aided muscle stimulation

    Thermal-aided muscle stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110

  • DeviceBody Temperature Stimulation

    Body temperature stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110

06

What researchers measure

Primary outcomes

  1. Muscle Contraction Force

    Measured in Newtons

    Time frame: At 30 s intervals for 20 minutes

07

Study locations

1 of 1 sites recruiting
  • Melchor Pavilion
    Mountain View, California 94040, United States
    • Bahman Nouri, MD · Contact · 650-962-4690
    • Bahman Nouri, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01911312
Lead sponsor
Niveus Medical, Inc.
Responsible party
Sponsor
First posted
Jul 30, 2013
Start date
Jul 2013
Primary completion
Sep 2013 (estimated)
Last update
Jul 30, 2013

Study contacts

Brian Fahey, PhD
Contact
brian@niveusmedical.com
650-336-7922
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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