NCT01399879

Brief Summary

The Scanning Kelvin Probe measures surface electrical potential without actually touching the skin. This is a pilot study to evaluate methods of minimizing noise during Scanning Kelvin Probe measurements. This project will focus specifically on noise arising from physical movement and environmental electrical field.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2010

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

5 months

First QC Date

March 25, 2011

Last Update Submit

July 20, 2011

Conditions

Keywords

Surface potentialElectricalMotion stabilization

Outcome Measures

Primary Outcomes (1)

  • Variability in surface electrical potential measurements

    This study focuses on the ability of the Kelvin Probe to measure skin electrical potential. Because it does so without touching the skin, it is prone to noise - specifically physical movement and surrounding electrical noise. The variability in surface electrical potential is a way to determine how stable the measurements are. It can be determined immediately after testing - and will be used in data analyses (comparing across study volunteers) approximately 24 weeks after testing is complete.

    Within 24 hours of testing

Study Arms (1)

Healthy Volunteers

Other: Faraday cage, movement stabilization

Interventions

The Faraday cage is a copper-mesh cage that surrounds the device and test site. It helps eliminate surrounding electrical noise. Movement stabilization will be achieved by placing a velcro strap over the arm to minimize random movements.

Healthy Volunteers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Age greater than 18 years

You may not qualify if:

  • chronic medical condition requiring daily medications (hypertension, diabetes, hypothyroidism, etc)
  • movement disorders/tremors
  • extensive scars on the hand
  • latex-allergies
  • cardiac implantation, metallic joint/bone replacements (defibrillator or pacemaker)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Andrew C Ahn, MD MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2011

First Posted

July 22, 2011

Study Start

September 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

July 22, 2011

Record last verified: 2011-07