Reliability of Pupil Response to Acute Pain

Study Purpose

The purpose of this research study is to test whether researchers can reliably measure the response pupils have when an acute painful stimulus is experienced. Changes in the size of the pupil of the eye can be an indicator of brain activity in a region of the brain that is important for feeling pain.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Adult (18-70) - Pain from hip or knee arthritis of moderate intensity.
  • - American Society of Anesthesiologists physical status 1-3.

Exclusion Criteria:

  • - Inability to complete study questionnaires.
  • - Pregnancy.
  • - Litigation or workers compensation related to hip or knee pain.
  • - Taking > 50 mg morphine equivalents/day.
  • - History of Raynaud's disease of the feet.
  • - Psychotic disorder or a recent psychiatric hospitalization.
- History of eye surgery or topical eye medications that would would directly affect pupil diameter

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02628314
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Wake Forest University Health Sciences
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

James C Eisenach, MD
Principal Investigator Affiliation Wake Forest University Health Sciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pain, Osteoarthritis
Additional Details

There is strong rationale to support a role for locus coeruleus (LC) responsivity to acute painful stimuli in regulating speed of recovery after surgery and for LC responsivity as a mechanistic link explaining the risks for slow recovery from weak Conditioned Pain Modulation (CPM), catastrophizing cognitive style, and low enzyme activity catecholamine-O-methyltransferase (COMT) genotype. Preliminary data show feasibility to perform the proposed study. Primary Hypothesis: An observational study of pupil responses to noxious stimuli shows strong intra-individual reliability over 8 weeks. Key secondary hypotheses: Compared to individuals homozygous for val at the val158met site of the catecholamine-O-methyltransferase (COMT) gene, those homozygous for met will show smaller pupil responses to noxious stimuli and weaker CPM.

Arms & Interventions

Arms

: Osteoarthritis

Study population to include adult men and women with osteoarthritis.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Wake Forest Baptist Medical Center, Winston-Salem 4499612, North Carolina 4482348

Status

Recruiting

Address

Wake Forest Baptist Medical Center

Winston-Salem 4499612, North Carolina 4482348, 27157

Site Contact

Regina Curry, RN

[email protected]

336-716-4294