NCT01911312

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

2 months

First QC Date

July 12, 2013

Last Update Submit

July 26, 2013

Conditions

WeaknessAtrophy

Outcome Measures

Primary Outcomes (1)

  • Muscle Contraction Force

    Measured in Newtons

    At 30 s intervals for 20 minutes

Study Arms (2)

Intervention

EXPERIMENTAL
Device: Thermal-aided muscle stimulation

Body Temperature Control

ACTIVE COMPARATOR

Stimulation performed with body temperature control

Device: Body Temperature Stimulation

Interventions

Thermal-aided muscle stimulationDEVICE

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

Intervention
Body Temperature StimulationDEVICE

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

Body Temperature Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melchor Pavilion

Mountain View, California, 94040, United States

RECRUITING

MeSH Terms

Conditions

AstheniaAtrophy

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Central Study Contacts

Brian Fahey, PhD

CONTACT

650-336-7922brian@niveusmedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2013

First Posted

July 30, 2013

Study Start

July 1, 2013

Primary Completion

September 1, 2013

Last Updated

July 30, 2013

Record last verified: 2013-07

Locations

US(1)