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| Name | Class |
|---|---|
| Oklahoma State University | OTHER |
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The study will test a real-time functional magnetic resonance imaging (fMRI) hyperscanning neurofeedback protocol for feasibility with ten mothers and their psychiatrically healthy adolescent daughters, with the eventual goal to test this in a sample of depressed adolescents in a future study.
This study will utilize a rigorous multi-method, multi-informant design to examine the effects of dyadic neurofeedback (dnf) on adolescent brain activation with fMRI hyperscanning. Parents and adolescents will also report on emotion regulation, depressive symptoms, and parenting practices. Data collection procedures will take place at the Laureate Institute for Brain Research (LIBR), which is equipped with two identical scanners that have advanced real-time fMRI systems capable of conducting parallel fMRI hyperscanning, including the capacity for neurofeedback. Parents will complete a phone screen to determine initial eligibility. If initial study criteria are met, a 2-hour in-person lab visit will be scheduled where mothers and daughters will complete consent/assent; diagnostic interviews; surveys on emotion regulation, parenting practices, depression, and anxiety; and additional screening. Survey data will be used for preliminary exploratory analyses. Based on data collected from the screening visit, participants will be invited to participate in the full study: a 4-hour visit where mothers and daughters will complete emotion ratings, mock scanner training, and fMRI tasks individually and together using hyperscanning (scan time = 16 min resting-state [2 runs], 7 min structural MRI, 40 min fMRI tasks, 10 min clinical MRI scans).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real-time fMRI neurofeedback | Experimental | All participants will receive neurofeedback from the target region (no sham condition). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real-time fMRI neurofeedback | Behavioral | Participants will attempt to regulate own and/or their partner's brain activation in a specified brain region via real-time fMRI neurofeedback. |
| Measure | Description | Time Frame |
|---|---|---|
| Neurofeedback Rating Scale | Rating scale of perceived effectiveness in completing the task and changing brain activation. Likert scale ranging from 0-10, with higher numbers indicating greater perceived effectiveness. | Baseline (Acquired during scan session) |
| Emotion Rating Scale | Rating scale asking about current experience of various emotions (happy, sad, angry, etc.). Scale ranges from 0-10, with higher numbers indicating more intense emotions. | Baseline (Acquired during scan session) |
| Blood Oxygen Level-Dependent (BOLD) Signal Changes (Brain Activation) | Activation in the brain region targeted for neurofeedback and associated regions; resting-state network activity | Baseline (Acquired during scan session) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kara L Kerr, PhD | Oklahoma State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laureate Institute for Brain Research | Tulsa | Oklahoma | 74136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35721350 | Derived | Kerr KL, Ratliff EL, Cohen ZP, Fuller S, Cosgrove KT, DeVille DC, Misaki M, Morris AS, Bodurka J. Real-Time Functional Magnetic Resonance Imaging Dyadic Neurofeedback for Emotion Regulation: A Proof-of-Concept Study. Front Hum Neurosci. 2022 May 26;16:910951. doi: 10.3389/fnhum.2022.910951. eCollection 2022. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Real-time fMRI Neurofeedback | All participants will receive neurofeedback from the target region (no sham condition). Real-time fMRI neurofeedback: Participants will attempt to regulate own and/or their partner's brain activation in a specified brain region via real-time fMRI neurofeedback. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Real-time fMRI Neurofeedback | All participants will receive neurofeedback from the target region (no sham condition). Real-time fMRI neurofeedback: Participants will attempt to regulate own and/or their partner's brain activation in a specified brain region via real-time fMRI neurofeedback. |
| Units | Counts |
|---|---|
| Participants |
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| 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 Rating Scale | Rating scale of perceived effectiveness in completing the task and changing brain activation. Likert scale ranging from 0-10, with higher numbers indicating greater perceived effectiveness. | Parents who participated in at least one neurofeedback session with available data for this outcome variable | Posted | Mean | Standard Deviation | units on a scale | Baseline (Acquired during scan session) |
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3 months (Participants completed baseline measures over the course of approximately 1 month followed by 2 months of biweekly follow-ups.)
Definition does not differ from clinicaltrials.gov
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| 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 fMRI Neurofeedback | All participants will receive neurofeedback from the target region (no sham condition). Real-time fMRI neurofeedback: Participants will attempt to regulate own and/or their partner's brain activation in a specified brain region via real-time fMRI neurofeedback. |
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This is a feasibility study with a small sample and no control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kara Kerr | Oklahoma State University | 9186971478 | kara.kerr@okstate.edu |
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| 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 | Mar 15, 2019 | Nov 17, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 22, 2019 | Nov 16, 2023 | ICF_001.pdf |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Emotion Rating Scale | Rating scale asking about current experience of various emotions (happy, sad, angry, etc.). Scale ranges from 0-10, with higher numbers indicating more intense emotions. | Only data from participants used in the neuroimaging results were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Acquired during scan session) |
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| Primary | Blood Oxygen Level-Dependent (BOLD) Signal Changes (Brain Activation) | Activation in the brain region targeted for neurofeedback and associated regions; resting-state network activity | Only adolescents' data that passed quality control were analyzed. Values are taken from the anterior insula and averaged across scanning runs and participants. | Posted | Mean | Standard Deviation | percent signal change | Baseline (Acquired during scan session) |
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