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Behavioral Intervention
Diagnostic Tests Reliability for Pain Perception
N/A
Waitlist Available
Led By Benedict Alter, MD, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group
Summary
This trial is measuring how well two tests (OA and OH) work to show how the brain changes pain. These tests use a heat thermode to cause pain in healthy volunteers, and then additional surveys about pain will be collected. If these tests work well, they could be used to help develop new pain medications and to help choose treatments that would work best for each person.
Who is the study for?
This trial is for healthy, pain-free volunteers who have no chronic pain issues and can understand the study procedures. It's not suitable for those with a history of chronic pain, significant ongoing acute or chronic pain, recent migraines, mood disorders, taking certain medications affecting the nervous system, cognitive impairments, unstable medical conditions, pregnancy, forearm tattoos, heart or severe liver/gastrointestinal diseases.
What is being tested?
The study aims to test the reliability of offset analgesia (OA) and onset hyperalgesia (OH), which are methods used to measure how our brain controls pain. Participants will undergo heat-induced OA and OH tests across three visits along with other quantitative sensory testing and surveys related to pain modulation.
What are the potential side effects?
Since this trial involves non-invasive sensory testing primarily using a heat thermode on healthy individuals without any medication administration involved in the interventions being tested (Medoc cutaneous probe), side effects are expected to be minimal but may include temporary discomfort from heat exposure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Differences in brain region activation- QST (quantitative sensory tests)
Offset analgesia and onset hyperalgesia
Test retest reliability in brain region activation- QST (quantitative sensory tests)
+1 moreSecondary study objectives
Differences in resting fNIRS signaling
Pain intensity
Questionnaire score- Beck Depression Inventory-II (BDI-II)
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Healthy VolunteersExperimental Treatment3 Interventions
QST devices and computer tasks are used to measure OA, OH, pain intensity, and other outcomes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medoc cutaneous probe
2022
N/A
~80
Quantitative sensory testing
2022
Completed Phase 4
~710
Computer tasks
2022
N/A
~80
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,789 Previous Clinical Trials
16,359,549 Total Patients Enrolled
18 Trials studying Pain
8,751 Patients Enrolled for Pain
Benedict Alter, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
110 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a chronic severe infectious disease like HIV/AIDS.I have high blood pressure.I have severe liver disease.I have a severe stomach or intestine condition.I have had brain surgery in the past.I cannot walk on my own.I experience daily pain, whether it's new or long-term.I have heart issues like irregular heartbeat or artery problems.I have had a migraine in the last 2 years.I have a long-term history of pain.I am experiencing severe pain.I can understand and follow study instructions.I am not taking any psychiatric drugs or medications that affect the nervous system.I am healthy, have no chronic pain, and understand the study procedures.I have had seizures, fainting, severe headaches, stroke, or mini-strokes.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Volunteers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.