Generate and Test the Reliability of a PD Model of OXT on Pupillary Hippus as a Measure of CNS Activity
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Pain
- Osteoarthritis (Knee)
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Randomized, double blind, crossover study. Each participant will receive Oxytocin 25 micrograms and placebo via intramuscular injectionMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Randomization will be maintained by the research pharmacist and by an independent individual not affiliated with the data collection or outcome evaluationPrimary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
This is a single site study at Wake Forest School of Medicine. Healthy volunteers and patients with advanced knee arthritis being seen in the Orthopedic Clinic in consultation for potential total knee arthroplasty will be recruited after their doctor visit if the decision is made not to perform surg...
This is a single site study at Wake Forest School of Medicine. Healthy volunteers and patients with advanced knee arthritis being seen in the Orthopedic Clinic in consultation for potential total knee arthroplasty will be recruited after their doctor visit if the decision is made not to perform surgery at this time. Study participants will come to the Pain Clinical Research Unit on 2 occasions. On these visits, they will receive an intramuscular (i.m.) injection of placebo or oxytocin, 25 micrograms (?g) (Pitocin®), obtained from the research pharmacy. The order in this cross-over study will be randomized and double blind, and the studies separated by at least 48 hours. Every 2.5 minutes beginning 20 minutes before injection and until 180 minutes after injection oscillation in pupil diameter at low frequency (hippus) will be obtained using an infrared pupilometer, in which they focus on a central point of gaze for 20 seconds. Hippus, a measure of parasympathetic output to the pupil and affected by central actions of oxytocin as described in preliminary data, will be calculated as the magnitude of power in the 0-0.25 Hertz (Hz) bin of the spectral analysis of pupil diameter, after removing blink and saccade artifacts. After 180 minutes the study participant will be discharged from the Pain Clinical Research Unit.
Tracking Information
- NCT #
- NCT04427709
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: James C Eisenach, MD Wake Forest University Health Sciences
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