Trial Outcomes & Findings for Neural Correlates of Lidocaine Analgesia (NCT NCT05501600)

Last Updated: 2024-12-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

30 participants

Primary outcome timeframe

4.5 minutes

Results posted on

2024-12-24

Participant Flow

Participant milestones

Participant milestones
Measure	Lidocaine Subjects will receive lidocaine during the drug portion of the experiment. Peripheral Nerve Stimulation: Experimental acute pain stimulus will be delivered using an electric nerve stimulator. Lidocaine IV: Subjects will receive an intravenous infusion of lidocaine for about 30 minutes.
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neural Correlates of Lidocaine Analgesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine n=27 Participants Subjects receiving lidocaine during the drug portion of the experiment.
Age, Continuous	31.4 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4.5 minutes

Outcome measures

Outcome measures
Measure	Lidocaine n=27 Participants Subjects receiving lidocaine during the drug portion of the experiment.
Brain Activation to Painful Stimulation Difference: Drug-free Condition Minus Lidocaine Condition	3.6 Z-score

PRIMARY outcome

Timeframe: 8 minutes

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.

Outcome measures

Outcome measures
Measure	Lidocaine n=27 Participants Subjects receiving lidocaine during the drug portion of the experiment.
Resting-state Functional Connectivity Difference: Drug-free Minus Lidocaine	3.25 T-statistic

SECONDARY outcome

Timeframe: 12 minutes

Numerical rating scale (0-10) pain score difference, comparing drug-free to the 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).

Outcome measures

Outcome measures
Measure	Lidocaine n=27 Participants Subjects receiving lidocaine during the drug portion of the experiment.
Pain Intensity Score Difference, Drug-free Condition Minus Lidocaine Condition	0.4 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Lidocaine n=27 Participants Subjects receiving lidocaine during the drug portion of the experiment.
Memory Performance Difference, Drug-free Minus Lidocaine Condition	0.48 d-prime Interval 0.12 to 0.85

SECONDARY outcome

Timeframe: 1 minute

Response times (in ms) after hearing a tone will be recorded and compared between the drug-free and Lidocaine condition, with the calculated difference in response times reported. Higher values will reflect slower responses, which are expected under the lidocaine condition.

Outcome measures

Outcome measures
Measure	Lidocaine n=27 Participants Subjects receiving lidocaine during the drug portion of the experiment.
Motor Response Time Differences	10 milliseconds Standard Deviation 100

Adverse Events

Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Keith Vogt

University of Pittsburgh

Phone: 412-647-3147

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place