Evaluation of Thermal-Aided Muscle Stimulation

NCT ID: NCT01911312

Last Updated: 2013-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Brief Summary

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

Detailed Description

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Conditions

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Weakness Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

Thermal-aided muscle stimulation

Intervention Type DEVICE

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

Body Temperature Control

Stimulation performed with body temperature control

Group Type ACTIVE_COMPARATOR

Body Temperature Stimulation

Intervention Type DEVICE

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

Interventions

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Thermal-aided muscle stimulation

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

Intervention Type DEVICE

Body Temperature Stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Niveus Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Melchor Pavilion

Mountain View, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brian Fahey, PhD

Role: CONTACT

650-336-7922

Facility Contacts

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Bahman Nouri, MD

Role: primary

650-962-4690

Other Identifiers

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CLP3.00

Identifier Type: -

Identifier Source: org_study_id

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