AnesthesiaPhase 1NeuCLANCT05501600
Neural Correlates of Lidocaine Analgesia
A Phase 1 study testing Peripheral Nerve Stimulation and Lidocaine IV in people with Anesthesia and Pain, run by Keith M Vogt at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Pain
- What is being tested?
- Peripheral Nerve Stimulation and Lidocaine IV
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2022to 17 Nov 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Having Wolff-Parkinson-White syndrome
- Having known renal or hepatic dysfunction
- having glucose-6-phosphate dehydrogenase deficiency or history of methemoglobinemia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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. A steady-state effect-site concentration of lidocaine will be achieved, and a short battery of cognitive behavioral tasks will be employed. At the 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 a steady-state dose of IV lidocaine using a short battery of tasks. The investigators hypothesize that the administration of lidocaine will correlate to decreased pain ratings, slowed psychomotor response, and decreased memory encoding.
Aim2: Determine the neural effects of a steady-state dose 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 widespread decreases in long-range functional connectivity between brain areas know to be involved in these two areas and other known to be involved in pain processing.
- Conditions
- Anesthesia, Pain
- Being tested
- Peripheral Nerve Stimulation, Lidocaine IV
- Keywords
- lidocaine, functional MRI, electric nerve stimulation, functional connectivity
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Nerve StimulationDevice
Also called Electric Nerve Stimulation
Experimental acute pain stimulus will be delivered using an electric nerve stimulator.
Lidocaine IVDrug
Also called Xylocaine
Subjects will receive an intravenous infusion of lidocaine for about 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Subjects will receive lidocaine during the drug portion of the experiment. Receives: Device: Peripheral Nerve Stimulation; Drug: Lidocaine IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 minutes
Secondary outcomes (3)
Pain Intensity Score Difference, Drug-free Condition Minus Lidocaine Condition
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).
Measured: 12 minutes
Memory Performance Difference, Drug-free Minus Lidocaine Condition
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.
Measured: 3 minutes
Motor Response Time Differences
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.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start22 Nov 2022
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keith M Vogt
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor-investigator, Keith M Vogt, University of Pittsburgh
- Investigators
- Keith M Vogt, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501600
- Sponsor's protocol ID
- STUDY21120115
- Other IDs
- R35GM146822
- Acronym
- NeuCLA
- Status last verified
- Dec 2024
- First submitted
- 2 Aug 2022
- Last updated
- 24 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39438214
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Lidocaine Analgesia
- ClinicalTrials.gov ID
- NCT05501600
- Acronym / sponsor ID
- NeuCLA / STUDY21120115
- Conditions
- Anesthesia, Pain
- Keywords
- lidocaine, functional MRI, electric nerve stimulation, functional connectivity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Keith M VogtUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Posted 24 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. A steady-state effect-site concentration of lidocaine will be achieved, and a short battery of cognitive behavioral tasks will be employed. At the 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 a steady-state dose of IV lidocaine using a short battery of tasks. The investigators hypothesize that the administration of lidocaine will correlate to decreased pain ratings, slowed psychomotor response, and decreased memory encoding.
Aim2: Determine the neural effects of a steady-state dose 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 widespread decreases in long-range functional connectivity between brain areas know to be involved in these two areas and other known to be involved in pain processing.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Device: Peripheral Nerve Stimulation, Drug: Lidocaine IVSubjects will receive lidocaine during the drug portion of the experiment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral Nerve StimulationAlso: Electric Nerve StimulationExperimental acute pain stimulus will be delivered using an electric nerve stimulator. | Device | Lidocaine |
| Lidocaine IVAlso: XylocaineSubjects will receive an intravenous infusion of lidocaine for about 30 minutes. | Drug | Lidocaine |
Primary outcome
Brain Activation to Painful Stimulation Difference: Drug-free Condition Minus Lidocaine Condition
Time frame: 4.5 minutes
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.
Resting-state Functional Connectivity Difference: Drug-free Minus Lidocaine
Time frame: 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.
3 secondary outcomes
Pain Intensity Score Difference, Drug-free Condition Minus Lidocaine Condition
Time frame: 12 minutes
Memory Performance Difference, Drug-free Minus Lidocaine Condition
Time frame: 3 minutes
Motor Response Time Differences
Time frame: 1 minute
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39438214Vogt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith M Vogt, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Peripheral Nerve Stimulation and Lidocaine IV in people with Anesthesia and Pain, run by Keith M Vogt at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Activation to Painful Stimulation Difference: Drug-free Condition Minus Lidocaine Condition (time frame: 4.5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05501600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.