Back to resultsEvaluation of Thermal-Aided Muscle Stimulation
Primary Purpose
Weakness, Atrophy
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thermal-aided muscle stimulation
Body Temperature Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Weakness
Eligibility Criteria
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
Sites / Locations
- Melchor PavilionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Body Temperature Control
Arm Description
Stimulation performed with body temperature control
Outcomes
Primary Outcome Measures
Muscle Contraction Force
Measured in Newtons
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01911312
Brief Title
Evaluation of Thermal-Aided Muscle Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Niveus Medical, Inc.
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weakness, Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Body Temperature Control
Arm Type
Active Comparator
Arm Description
Stimulation performed with body temperature control
Intervention Type
Device
Intervention Name(s)
Thermal-aided muscle stimulation
Intervention Description
Thermal-aided muscle stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110
Intervention Type
Device
Intervention Name(s)
Body Temperature Stimulation
Intervention Description
Body temperature stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110
Primary Outcome Measure Information:
Title
Muscle Contraction Force
Description
Measured in Newtons
Time Frame
At 30 s intervals for 20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Fahey, PhD
Phone
650-336-7922
Email
brian@niveusmedical.com
Facility Information:
Facility Name
Melchor Pavilion
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bahman Nouri, MD
Phone
650-962-4690
First Name & Middle Initial & Last Name & Degree
Bahman Nouri, MD
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Thermal-Aided Muscle Stimulation
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