Healthy StateNCT01399879
Measuring Skin Electrical Potential With the Kelvin Probe: Minimizing Noise
An observational study of Healthy State, run by Massachusetts General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy State
- What is being tested?
- Faraday cage, movement stabilization
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Age greater than 18 years
Who cannot join
- 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)
About this study
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.
- Conditions
- Healthy State
- Being tested
- Faraday cage, movement stabilization
- Keywords
- Surface potential, Electrical, Motion stabilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faraday cage, movement stabilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Not described Receives: Other: Faraday cage, movement stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours of testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startSep 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy StateStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Andrew C Ahn, MD MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399879
- Sponsor's protocol ID
- 5R21AT005249
- Status last verified
- Jul 2011
- First submitted
- 25 Mar 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Skin Electrical Potential With the Kelvin Probe: Minimizing Noise
- ClinicalTrials.gov ID
- NCT01399879
- Acronym / sponsor ID
- 5R21AT005249
- Conditions
- Healthy State
- Keywords
- Surface potential, Electrical, Motion stabilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Other: Faraday cage, movement stabilization |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (1 listed)
- Age greater than 18 years
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faraday cage, movement stabilizationThe 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. | Other | Healthy Volunteers |
Primary outcome
Variability in surface electrical potential measurements
Time frame: Within 24 hours of testing
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew C Ahn, MD MPH principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy State, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability in surface electrical potential measurements (time frame: Within 24 hours of testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2011.