Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06626789
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Brain Signal Training to Enhance Affect Down-regulation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-center Patient-blinded and Investigator-blinded Randomized Parallel-group Superiority Study to Compare the Efficacy of Four Sessions of Amygdala FMRI-BOLD Neurofeedback with Yoked Sham-control Neurofeedback in the Treatment of Dysregulated Affect in Borderline Personality Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BrainSTEADy
Brief Summary:
Individuals with Borderline Personality Disorder BPD experience intensive instable negative emotions Hyperactivity of the amygdala is assumed to drive exaggerated emotional responses in BPD Neurofeedback is an endogenous neuromodulation method to address the imbalance of neural circuits Downregulation of amygdala hyperactivation with neurofeedback may ameliorate dysregulated emotions in BPD The BrainSTEADy trial is designed to determine whether amygdala-fMRI-BOLD neurofeedback has a specific effect on affect instability in BPD beyond nonspecific benefit
Detailed Description:
Borderline Personality Disorder BPD is characterized by self-mutilation suicidality and severe interpersonal disturbances These symptoms reflect pervasive emotion regulation problems On the neural level BPD patients show an inflated amygdala response to emotional cues In addition they have reduced neural control of the amygdala The amygdala controls emotional experience and behavior Therefore current psychobiological theories consider amygdala hyper-activity a causal mechanism for emotional overreaction in BPD
Functional magnetic resonance imaging fMRI allows the recording of activation in subcortical brain regions such as the amygdala in real time Live feedback from brain activation eg via a thermometer with the temperature reflecting the degree of activation allows one to learn the voluntary control of the brain Dubbed neurofeedback NF the method can result in long-lasting changes in neural activation patterns NF allows precise targeting of dysfunctional neuro-circuitries that relate to clinical symptoms
The project proposed here investigates the clinical effectivity of fMRI-based amygdala-NF training in BPD In total 164 patients will participate in four training sessions provided by four study centers Tuebingen Freiburg Giessen and Mannheim The training aims to reduce affective instability in everyday life which is assessed primarily by ambulatory assessment before and after treatment During NF sessions patients receive feedback from the BOLD Blood Oxygenation Level Dependent signal recorded in the amygdala while they view pictures with negative emotional content The amygdala responds to these pictures with an activation increase The patient observes the amygdala responding illustrated via increased temperature in a thermometer beside the picture The task is to decrease temperature The procedure should teach patients to master overreaction at an early stage of neural emotion processing
To assess the effectivity of amygdala-NF a control group receives non-veridical feedback from a different patient The investigators expect a significant reduction in affective instability with amygdala-NF In addition the investigators expect a greater reduction in affective instability in the amygdala-NF group versus the control group
The trial will go through two stages of recruitment Stage 1 is reached after recruitment of 82 participants An interim analysis will be conducted Depending on the results of the interim analysis the trial will enter stage 2 ie recruitment of the full number of planned participants
Results from this study enable assessment of clinical efficacy of amygdala-NF In the future NF could serve as a precise tool for person-centered treatment of affective instability symptoms in mental disorders with severe emotion regulation problems such as BPD
Functional magnetic resonance imaging fMRI allows the recording of activation in subcortical brain regions such as the amygdala in real time Live feedback from brain activation eg via a thermometer with the temperature reflecting the degree of activation allows one to learn the voluntary control of the brain Dubbed neurofeedback NF the method can result in long-lasting changes in neural activation patterns NF allows precise targeting of dysfunctional neuro-circuitries that relate to clinical symptoms
The project proposed here investigates the clinical effectivity of fMRI-based amygdala-NF training in BPD In total 164 patients will participate in four training sessions provided by four study centers Tuebingen Freiburg Giessen and Mannheim The training aims to reduce affective instability in everyday life which is assessed primarily by ambulatory assessment before and after treatment During NF sessions patients receive feedback from the BOLD Blood Oxygenation Level Dependent signal recorded in the amygdala while they view pictures with negative emotional content The amygdala responds to these pictures with an activation increase The patient observes the amygdala responding illustrated via increased temperature in a thermometer beside the picture The task is to decrease temperature The procedure should teach patients to master overreaction at an early stage of neural emotion processing
To assess the effectivity of amygdala-NF a control group receives non-veridical feedback from a different patient The investigators expect a significant reduction in affective instability with amygdala-NF In addition the investigators expect a greater reduction in affective instability in the amygdala-NF group versus the control group
The trial will go through two stages of recruitment Stage 1 is reached after recruitment of 82 participants An interim analysis will be conducted Depending on the results of the interim analysis the trial will enter stage 2 ie recruitment of the full number of planned participants
Results from this study enable assessment of clinical efficacy of amygdala-NF In the future NF could serve as a precise tool for person-centered treatment of affective instability symptoms in mental disorders with severe emotion regulation problems such as BPD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None