Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fralin Biomedical Research Institute | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The investigators will use real-time fMRI neurofeedback to enhance participants' ability to control their ability to modulate alcohol valuation.
All study procedures will take place during a single study visit. Before the imaging session, a research assistant will aid the participant to select salient images related to individualized future goals as well as alcohol images which elicit self-reported craving. All participants will complete two fMRI runs within a single session. In run 1 of the scan (offline classifier training), participants will perform an image viewing task displaying alternating blocks of these goal- and alcohol-related images. Between the image viewing blocks we will assess reinforcer pathology with brief in-scanner measures of alcohol valuation (BAAD). In total, there will be six blocks each of the goal-oriented images, alcohol-related images, and BAAD (18 blocks total). Since this is a proof-of-concept experiment, the interspersed BAAD blocks will enable monitoring and validating changes in the participant's alcohol valuation after the image viewing blocks. Only the fMRI measures of goal- and alcohol-related image viewing will be used to build a support vector classifier (SVC). The participants will see a dial with a needle on the screen along with instructions to think of either future goals or alcohol cues. The dial will be directly controlled by ongoing output from the SVC, updating the needle position as participants imagine immediate (alcohol-related) or delayed (goal-related) cues. Based on this, it is expected that participants will have increased whole-brain signal-to-noise for alcohol vs. goal fMRI analyses and increased recruitment of frontal-parietal networks from enhanced visual attention to the task.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real Time Neurofeedback | Experimental | Real time neurofeedback will be based on a classifier of increasing or decreasing alcohol craving/demand fMRI patterns. Participants will try to modulate their brain patterns based on neurofeedback via a visual dial during an fMRI scan. Participants will be told they will be controlling the visual dial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real Time Neurofeedback | Behavioral | Participants receive feedback from their own brain activity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurofeedback Control | Participants were asked to move a neurofeedback dial to "alcohol" or "goal" directions. For the "alcohol" they were instructed to attempt to crave alcohol, and for the "goal" they were instructed to attempt to project themselves into their future goals. The outcome was measured by the mean correlation of the needle movement compared to the instructed needle movement. | During the real time fMRI scan, approximately 1 hour (single session) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephen M LaConte, PhD | Fralin Biomedical Research Institute (FBRI) at VTC | Principal Investigator |
| Warren K Bickel, PhD | Fralin Biomedical Research Institute (FBRI) at VTC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fralin Biomedical Research Institute at VTC | Roanoke | Virginia | 24016 | United States |
Investigators will adhere to all NIH requirements regarding data sharing. Participant data collected in this project will be de-identified and made available on a shared secured data repository. We will also share the analysis results. As part of this process, all investigators will be required to agree to the following conditions: 1) will adhere to the reporting responsibilities; 2) will not redistribute the data beyond the requesting individual and named collaborators; 3) will give appropriate acknowledgement; 4) will not use the data for commercial purposes; and 5) will obtain appropriate ethical approvals. Results from research conducted will be shared and disseminated, including: regular project meetings, annual meetings, symposia, workshops, and/or conferences for related groups. Manuscripts will be written and submitted for publication in peer-reviewed journals/conferences, following the NIH Public Access Policy guidelines. All necessary ethical approvals will be obtained.
Not provided
Data will be made available upon request after dissemination of results.
Data requests will be reviewed by the principal investigator and data will be shared with the expectation of acknowledgment of funding source and primary study team.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Real Time Neurofeedback | Real time neurofeedback will be based on a classifier of increasing or decreasing alcohol craving/demand fMRI patterns. Participants will try to modulate their brain patterns based on neurofeedback via a visual dial during an fMRI scan. Participants will be told they will be controlling the visual dial. Real Time Neurofeedback: Participants receive feedback from their own brain activity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Real Time Neurofeedback | Real time neurofeedback will be based on a classifier of increasing or decreasing alcohol craving/demand fMRI patterns. Participants will try to modulate their brain patterns based on neurofeedback via a visual dial during an fMRI scan. Participants will be told they will be controlling the visual dial. Real Time Neurofeedback: Participants receive feedback from their own brain activity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neurofeedback Control | Participants were asked to move a neurofeedback dial to "alcohol" or "goal" directions. For the "alcohol" they were instructed to attempt to crave alcohol, and for the "goal" they were instructed to attempt to project themselves into their future goals. The outcome was measured by the mean correlation of the needle movement compared to the instructed needle movement. | Posted | Mean | Standard Deviation | correlation coefficient | During the real time fMRI scan, approximately 1 hour (single session) |
|
During the real time fMRI scan, approximately 1 hour (single session)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Real Time Neurofeedback | Real time neurofeedback will be based on a classifier of increasing or decreasing alcohol craving/demand fMRI patterns. Participants will try to modulate their brain patterns based on neurofeedback via a visual dial during an fMRI scan. Participants will be told they will be controlling the visual dial. Real Time Neurofeedback: Participants receive feedback from their own brain activity. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen LaConte | Virginia Tech | 5405262008 | slaconte@vtc.vt.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2023 | Dec 3, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
Not provided
Not provided
Not provided