NeuCLA: Neural Correlates of Lidocaine Analgesia
Study Details
Study Description
Brief Summary
The purpose of this study is to characterize the effects of intravenous lidocaine on pain processing and cognitive function. Functional magnetic resonance imaging will be used to identify the neural correlates of these phenomena. The study will consist of 1 visit and involves no long-term follow up.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This is an observational cohort study of volunteer subjects, which will employ neuroimaging and behavioral measures to characterize the effects of intravenous lidocaine on pain processing and cognitive function. Two steady-state effect-site concentrations of lidocaine will be achieved, and a short battery of cognitive behavioral tasks will be employed. At each dose target, pain task functional MRI and resting-state connectivity will be determined. This work will use a systems neuroscience approach to fill an important knowledge gap about the central effects of intravenous lidocaine, a commonly-used opioid alternative analgesic agent.
Aim1: Determine cognitive behavioral effects of two doses of IV lidocaine using a short battery of tasks. The investigators hypothesize that increasing doses of lidocaine will correlate to decreased pain ratings and decreased memory encoding.
Aim2: Determine the neural effects of two doses of IV lidocaine in response to acute pain, and on resting connectivity. The investigators hypothesize that pain task-related activation will decrease in the insula and anterior cingulate, corresponding to decreased ratings of pain intensity and unpleasantness. Additionally, the investigators expect dose-dependent widespread decreases in long-range functional connectivity between brain areas know to be involved in pain processing.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lidocaine Subjects will receive lidocaine during the drug portion of the experiment. |
Device: Peripheral Nerve Stimulation
Experimental acute pain stimulus will be delivered using a nerve stimulator.
Other Names:
Drug: Lidocaine IV
Subjects will receive an intravenous infusion of lidocaine over 60 minutes.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Brain activation to painful stimulation difference: drug-free condition minus lower-dose lidocaine [4.5 minutes]
BOLD fMRI-based activation (T-score for task periods minus rest periods), in response to painful stimulation comparing drug-free condition minus the value calculated during the lower steady-state dose of lidocaine.
- Resting-state functional connectivity difference: drug-free minus lower-dose lidocaine [8 minutes]
Functional connectivity (correlation coefficient) for resting-state BOLD oscillations between pain-processing brain areas, comparing value during drug-free condition minus the value during lower steady-state dose of lidocaine.
- Brain activation to painful stimulation difference: drug-free condition minus higher-dose lidocaine [4.5 minutes]
BOLD fMRI-based activation (T-score for task periods minus rest periods), in response to painful stimulation comparing drug-free condition minus the value calculated during the higher steady-state dose of lidocaine.
- Resting-state functional connectivity difference: drug-free minus higher-dose lidocaine [8 minutes]
Functional connectivity (correlation coefficient) for resting-state BOLD oscillations between pain-processing brain areas, comparing value during drug-free condition minus the value during highersteady-state dose of lidocaine.
Secondary Outcome Measures
- Pain score difference, drug-free condition minus lower-dose lidocaine condition [12 minutes]
Numerical rating scale (0-10) pain score difference, comparing drug-free to lower steady-state dose of lidocaine. Higher pain scores indicate more pain; a positive difference between pain score during the drug-free condition minus the value during the lidocaine condition indicates pain reduction (a better outcome).
- Pain score difference, drug-free condition minus higher-dose lidocaine condition [12 minutes]
Numerical rating scale (0-10) pain score difference, comparing drug-free to higher steady-state dose of lidocaine. Higher pain scores indicate more pain; a positive difference for pain score during the drug-free condition minus the value during the lidocaine condition indicates pain reduction (a better outcome).
- Memory performance difference, drug-free minus lower-dose lidocaine condition [3 minutes]
Performance on a short computer-based test of memory for visual pictures will be quantified using signal detection metric d-prime, reflecting ability (in standard deviation units) to detect previously-seen images from the background "noise" of previously un-seen images. Differences will be determined between the drug-free condition and the lower-dose lidocaine condition. Higher values of d-prime indicate stronger memory performance; a positive difference for drug-free minus lidocaine condition would indicate the expected decrease in memory performance.
- Memory performance difference, drug-free minus higher-dose lidocaine condition [3 minutes]
Performance on a short computer-based test of memory for visual pictures will be quantified using signal detection metric d-prime, reflecting ability (in standard deviation units) to detect previously-seen images from the background "noise" of previously un-seen images. Differences will be determined between the drug-free condition and the higher-dose lidocaine condition. Higher values of d-prime indicate stronger memory performance; a positive difference for drug-free minus lidocaine condition would indicate the expected decrease in memory performance.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adults aged 18 to 70
-
Be of normal body-weight
-
Be generally healthy
-
Have none of the specific exclusion criteria
-
Have a valid email address and phone number throughout the study
Exclusion Criteria:
-
Pregnancy
-
Body mass index > 40
-
Having chronic pain requiring the regular use of pain medicine
-
Having neurologic or psychiatric disease, including anxiety, and depression
-
Having history of cardiac rhythm disturbance (such as heart block, or atrial fibrillation)
-
Being severely claustrophobic
-
Having metal implants or non-removable metal piercings
-
Having metal-containing tattoos, particularly on the face
-
Having a history of adverse reaction to lidocaine
-
Are regularly taking: antiepileptics, antidepressants, anti-psychotics, anti-anxiety medication, stimulants, sleep-aids, or pain medication
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- Keith M. Vogt, MD, PhD
- National Institute of General Medical Sciences (NIGMS)
Investigators
- Principal Investigator: Keith M Vogt, MD, PhD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY21120115
- R35GM146822