Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R35GM146822 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
Not provided
Not provided
Not provided
This is a single-arm functional MRI study that will determine the effects of remimazolam on cognition and brain activity and connectivity at rest, during noxious stimulation, and during a memory encoding task
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam+Pain | Experimental | Single-arm study. All subjects receive remimazolam and painful electric nerve stimulation, while being imaged with MRI, as described in the interventions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | Subjects in this group will receive an intravenous infusion of this drug, during a portion of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Explicit memory performance | Recognition memory testing, using the Remember-Know procedure, in which subjects indicate whether they recognize previously experienced experimental items among novel items (not previously in the experiment). This allows calculation of interdependent measures of recollection & familiarity using the signal detection statistic, d'. d' is calculated as the cumulative Gaussian distribution of false positive responses subtracted from the cumulative Gaussian distribution of correctly identified previously-experienced items. d' is on a (theoretically infinite) scale of standard deviation units, with negative values representing performance worse than chance guessing and positive values representing stand deviations of performance above chance. Cross-condition comparisons will be the main effect of interest, comparing no drug to remimazolam. | Day/Visit 2: 12-36 hours after day 1 session |
| subjective pain ratings | Numerical ratings of pain intensity and unpleasantness will be obtained after each experimental period involving repeated noxious stimulation. Values will be on a 0-10 scale, with 0 representing none and 10 representing the worst possible rating. | Day/Visit 1: immediately after no-drug condition MRI scan and immediately after remimazolam condition MRI scan |
| Measure | Description | Time Frame |
|---|---|---|
| functional magnetic resonance imaging activation of memory encoding task | Event-related blood-oxygen level dependent (BOLD) Magnetic Resonance Imaging (MRI) responses will be determined for each experimental item presented, revealing localized changes in blood flow, which correlate to increased neuronal activity. These will be averaged across the multiple repetitions of memory-encoding experimental events, creating an anatomical map of Z-scores. Cross-condition comparisons will be the main effect of interest, comparing no drug to remimazolam. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keith M Vogt, MD, PhD | Contact | 4126473147 | kev18@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Keith M Vogt, MD, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
De-identified data to share:
After analysis is complete and results have been published, all the above data will be shared in de-identified format, linked together by an assigned subject number.
Data will be shared via a publicly-accessible online platform that allows user download at no cost.
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C522201 | remimazolam |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Peripheral Nerve Stimulation | Device | Experimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired with a fixed number of the experimental cues, in a pattern that appears random to participants. |
|
| Day/Visit 1: during no-drug condition MRI scan and during remimazolam MRI scan |
| functional magnetic resonance imaging activation of the response to noxious stimulation | Event-related blood-oxygen level dependent (BOLD) Magnetic Resonance Imaging (MRI) responses will be determined for each experimental item presented, revealing localized changes in blood flow, which correlate to increased neuronal activity. These will be averaged across the multiple repetitions of noxious stimulation events, creating an anatomical map of Z-scores. Cross-condition comparisons will be the main effect of interest, comparing no drug to remimazolam. | Day/Visit 1: during no-drug condition MRI scan and during remimazolam MRI scan |
| Functional connectivity | Whole-brain functional connectivity will be determined in each condition (no-drug and remimazolam). This generates a matrix of cross-correlation values. Cross-condition comparisons will be the main effect of interest, comparing no drug to remimazolam. | Day/Visit 1: during no-drug condition MRI scan, during remimazolam MRI scan |