Objective Measurement of Pain Using the Algometer

NCT02325284 | Completed

• 1 other identifier: Algometer/Phase 1 pilot study
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The development of tools for assessment and management of pain in newborns and children is a high priority and represents a significant unmet need. The inadequate treatment of pain and the overuse of analgesics can cause harmful consequences for neonates, infants, and children. To accomplish successful pain management in children one must first objectively assess pain. Thus, to address these critical issues with pain management, the Human Algometer and methods are under development by Drs. Julia Finkel and Zena Quezado, Pain Medicine Program (SZI) at Children's National Medical Center.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Collection of data for signal processing that will generate the algorithms and data filters required to establish proof of concept for the novel technology.

  The data collected and process from the human algometer will generate a specific NIRS nociceptive response to neurostimulation in the somatosensory cortex.

  one year

Study Arms (1)

Healthy adults

Device: Pressure Algometer Testing

Interventions

Pressure Algometer Testing DEVICE

Also known as: Wagner FPIX 50™ digital pressure algometer.

Healthy adults

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults.

You may qualify if:

• the subject 18-65 years of age.
• the subject is a healthy adult with significant ongoing medical conditions
• the subject is willing to remain at the research site for the duration of the study session.
• the subject is willing and able to provide written informed consent to study participation.

You may not qualify if:

• the subject has consumed alcohol within the last 12 hours prior to testing
• subject has pain at the time of testing anywhere in the body

Sponsors & Collaborators

• Julia Finkel: lead
• CoolCad Electronics, LLC; University of Maryland Engineering: collaborator

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 24, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

US (1)