Neural Correlates of Lidocaine Analgesia

NCT05501600 | Completed Phase 1 Results FDA Drug FDA Device

• 2 other identifiers: STUDY21120115R35GM146822
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Pain

Keywords

lidocaine; functional MRI; electric nerve stimulation; functional connectivity

Outcome Measures

Primary Outcomes (2)

• Brain Activation to Painful Stimulation Difference: Drug-free Condition Minus Lidocaine Condition

  The Z-score is calculated by linear regression of the task timing against the MRI signal time-course (MRI data is in arbitrary units with no maximum or minimum) at each voxel (single data point in brain). Primary outcome is listed for the Right insula, but similar scores are calculated throughout the brain. Z-score of 0 indicates no task-related changes. Z-scores further from zero indicate stronger correlation between functional MRI signal change and the task timing, with positive values indicating increases in fMRI signal and negative Z-scores indicating decreases. Practically, higher positive Z-scores indicate increased brain activity and larger negative Z-scores indicate decreased brain activity. This outcome is reported as a number, as it is calculated using all the data across subjects combined into one statistical measure for the overall strength of difference in MRI signal change between two groups of data. Dispersion measures cannot be calculated for the summary Z-score.

  4.5 minutes

• Resting-state Functional Connectivity Difference: Drug-free Minus Lidocaine

  Functional connectivity (FC) measures the correlation of MRI signal time-series between brain regions. Changes in FC reflect differences in brain state, in this case between drug-free and lidocaine conditions. The reported value is the FC change between the right insula and anterior cingulate. A T-statistic of 0 indicates no change; more positive scores mean stronger connectivity in the drug-free condition, and more negative scores mean stronger connectivity with lidocaine. This outcome is a number reflecting the overall magnitude of difference between two datasets, calculated in one summary statistic. Dispersion measures cannot be calculated for the T-statistic in this analysis framework.

  8 minutes

Secondary Outcomes (3)

• Pain Intensity Score Difference, Drug-free Condition Minus Lidocaine Condition

  12 minutes

• Memory Performance Difference, Drug-free Minus Lidocaine Condition

  3 minutes

• Motor Response Time Differences

  1 minute

Study Arms (1)

Lidocaine

EXPERIMENTAL

Subjects will receive lidocaine during the drug portion of the experiment.

Device: Peripheral Nerve Stimulation; Drug: Lidocaine IV

Interventions

Peripheral Nerve Stimulation DEVICE

Experimental acute pain stimulus will be delivered using an electric nerve stimulator.

Also known as: Electric Nerve Stimulation

Lidocaine

Lidocaine IV DRUG

Subjects will receive an intravenous infusion of lidocaine for about 30 minutes.

Also known as: Xylocaine

Lidocaine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 70
• Be of normal body-weight
• Be generally healthy

You may not qualify if:

• Have a valid email address and phone number throughout the study
• Pregnancy
• Body mass index \> 40
• Having moderate to severe sleep apnea
• Having chronic pain requiring the regular use of pain medicine 3 or more times per week
• Having neurologic or psychiatric disease, including benign tremor, anxiety, and depression
• Having a history of seizures
• 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
• Are taking prescribed medications for psychiatric or neurological conditions
• Having hypersensitivity to lidocaine or to any other local anesthetics of the amide type

Sponsors & Collaborators

• Keith M Vogt: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Vogt KM, Burlew AC, Simmons MA, Reddy SN, Kozdron CN, Ibinson JW. Neural correlates of systemic lidocaine administration in healthy adults measured by functional MRI: a single arm open label study. Br J Anaesth. 2025 Feb;134(2):414-424. doi: 10.1016/j.bja.2024.07.039. Epub 2024 Oct 21.

  PMID: 39438214 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Keith Vogt
• Organization: University of Pittsburgh

vogtkm@upmc.edu

412-647-3147

Study Officials

• Keith M Vogt, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology & Perioperative Medicine

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 15, 2022
• Study Start: November 22, 2022
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: December 24, 2024
• Results First Posted: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)