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NCT01545973 Clinical Trial

Understanding the Physiological Implications of Scanning Kelvin Probe Measurements

Healthy Individuals Clinical Trial

Official title:
Measuring Skin Electrical Potential With the Kelvin Probe: Underlying Physiology

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT01545973
Other study ID # 55R21AT005249-02
Secondary ID
Status Suspended
Phase N/A
First received March 2, 2012
Last updated March 2, 2012
Start date August 2011
Est. completion date August 2012

Study information
Verified date March 2012
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the effects of skin thickness, skin moisture, and sweat gland density on Scanning Kelvin Probe measurements.

Description:

The Scanning Kelvin Probe measures the electrical potential of material surfaces without actually touching it. Although this technology has been applied to non-living materials (e.g. metal and semiconductors) before, it has not been effectively applied to biological materials, much less to live human skin . This project aims to evaluate the use of Scanning Kelvin Probe to live human skin by investigating the effects of skin thickness, skin moisture, and sweat glands on Kelvin Probe measurements of electrical potential. Testing will be performed on the arms and hands of twenty four healthy individuals under different study conditions.

Recruitment information / eligibility
Status Suspended
Enrollment 24
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- "Healthy" is defined as not having a chronic medical condition requiring daily medications (hypertension, diabetes, hypothyroidism, etc)

Exclusion Criteria:

- autonomic disorders (sweating irregularities), skin disorders, extensive burns/scars on the hand, tremors, neuromuscular conditions, restless leg syndrome, movement disorders, and implanted cardiac defibrillator/pacemaker

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Other:
• Skin Moistening, Skin Denuding
Application of normal saline to skin and Tape stripping of the superficial skin

Locations
Country Name City State
United States Massachusetts General Hospital - Martinos Center for Biomedical Imaging Charlestown Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Surface Electrical Potential The electrical potential of skin obtained from the Scanning Kelvin Probe 1 day No
Secondary Electrical Impedance Electrical impedance (measurement) obtained through another, more conventional measurement device. One day No
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