Back to resultsA Neurofeedback Booster for Emotion Regulation Therapy (BrainBoost)
Primary Purpose
Borderline Personality Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Neurofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder
Eligibility Criteria
Inclusion Criteria:
- DSM-5 BPD diagnosis
- informed consent
- EtOH and tox negative on the day of neurofeedback
- BSL-23 score >=1.87 at DBT halftime
Exclusion Criteria:
- pharmacotherapy with opiates
- standing benzodiazepines (bedtime-only benzodiazepines and anti-histamines allowed)
- pregnancy
- epilepsy
- life-time diagnosis schizophrenia or bipolar disorder I
- significant current or past neurological illness
- BMI<16.5
- usual safety criteria for magnetic resonance imaging
Sites / Locations
- Central Institute of Mental HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Outcomes
Primary Outcome Measures
Change in affective instability
Mean successive squared differences (MSSD) of six-item negative affect scale measured via behavioural sampling using ecological momentary assessment (EMA) over four days. MSSD will be compared between baseline and post-treatment timepoints.
Secondary Outcome Measures
Change in emotion regulation
Negative and neutral pictures are either presented with instruction to regulate or to respond naturally (view). BOLD response in the amygdala (and the rest of the brain) is measured and subjective ratings of regulation success are collected. Changes (between the time points) in differences of the two conditions (regulate vs. view) are measured for both: amygdala BOLD response and subjective ratings of regulation success.
Change in borderline symptomatology
Facets of BPD are assessed with questionnaires, including impulsivity. Borderline Symptom List (BSL-23) score will be used for assesment of BPD symptoms. This scale has 23 items, each scored 0-4, and total score is mean item endorsement (sum of all items divided by 23). Higher scores indicate more symptom endorsement.
Change in resting state brain connectivity
Patients get a 10 min brain scan (fMRI) without active task. Data are analysed to compare changes in intrinsic functional brain connectivity (BOLD activation of amygdala with other brain regions) during resting state before and after neurofeedback training.
Change in amygdala reactivity
Patients will perform a task, in which blocks of faces with negative emotional expressions and scrambled pictures will be presented. This task leads to considerable amygdala activation. With this task, we want to observe effects of neurofeedback on spontaneous amygdala activation.
Structural changes in the brain
By including DTI sequences before and after the neurofeedback intervention, we want to explore changes in FA/fiber structure of the brain. (exploratory analysis)
Full Information
NCT ID
NCT04333888
First Posted
March 26, 2020
Last Updated
March 4, 2022
Sponsor
Christian Paret
Collaborators
Yale University, AE Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04333888
Brief Title
A Neurofeedback Booster for Emotion Regulation Therapy
Acronym
BrainBoost
Official Title
BrainBoost - A Neurofeedback Booster for Emotion Regulation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christian Paret
Collaborators
Yale University, AE Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a proof-of-concept study that aims to test the additional value of adjuvant neurofeedback treatment for psychotherapy. Three sessions of real-time fMRI neurofeedback will be administered to N=22 patients with BPD while they receive residential Dialectical Behavior Therapy treatment. In addition, outcomes are assessed from a control group with same sample size who do not receive the treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Neurofeedback
Intervention Description
fMRI neurofeedback training of amygdala downregulation
Primary Outcome Measure Information:
Title
Change in affective instability
Description
Mean successive squared differences (MSSD) of six-item negative affect scale measured via behavioural sampling using ecological momentary assessment (EMA) over four days. MSSD will be compared between baseline and post-treatment timepoints.
Time Frame
Before treatment, immediately after treatment + follow-up measure (3 months)
Secondary Outcome Measure Information:
Title
Change in emotion regulation
Description
Negative and neutral pictures are either presented with instruction to regulate or to respond naturally (view). BOLD response in the amygdala (and the rest of the brain) is measured and subjective ratings of regulation success are collected. Changes (between the time points) in differences of the two conditions (regulate vs. view) are measured for both: amygdala BOLD response and subjective ratings of regulation success.
Time Frame
Before treatment, immediately after treatment + follow-up measure (3 months)
Title
Change in borderline symptomatology
Description
Facets of BPD are assessed with questionnaires, including impulsivity. Borderline Symptom List (BSL-23) score will be used for assesment of BPD symptoms. This scale has 23 items, each scored 0-4, and total score is mean item endorsement (sum of all items divided by 23). Higher scores indicate more symptom endorsement.
Time Frame
Before treatment, immediately after treatment + 2 follow-up measures (3 months, 6 months)
Title
Change in resting state brain connectivity
Description
Patients get a 10 min brain scan (fMRI) without active task. Data are analysed to compare changes in intrinsic functional brain connectivity (BOLD activation of amygdala with other brain regions) during resting state before and after neurofeedback training.
Time Frame
Before treatment, immediately after treatment + follow-up measure (3 months)
Title
Change in amygdala reactivity
Description
Patients will perform a task, in which blocks of faces with negative emotional expressions and scrambled pictures will be presented. This task leads to considerable amygdala activation. With this task, we want to observe effects of neurofeedback on spontaneous amygdala activation.
Time Frame
Before treatment, immediately after treatment + follow-up measure (3 months)
Title
Structural changes in the brain
Description
By including DTI sequences before and after the neurofeedback intervention, we want to explore changes in FA/fiber structure of the brain. (exploratory analysis)
Time Frame
Before the first neurofeedback training and after the last neurofeedback training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-5 BPD diagnosis
informed consent
EtOH and tox negative on the day of neurofeedback
BSL-23 score >=1.87 at DBT halftime
Exclusion Criteria:
pharmacotherapy with opiates
standing benzodiazepines (bedtime-only benzodiazepines and anti-histamines allowed)
pregnancy
epilepsy
life-time diagnosis schizophrenia or bipolar disorder I
significant current or past neurological illness
BMI<16.5
usual safety criteria for magnetic resonance imaging
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Paret, Dr. sc. hum.
Phone
(+49) 621 - 1703-4462
Email
christian.paret@zi-mannheim.de
Facility Information:
Facility Name
Central Institute of Mental Health
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paret
Phone
+49 621 1703
Ext
4462
Email
christian.paret@zi-mannheim.de
First Name & Middle Initial & Last Name & Degree
Miroslava Jindrova, Msc.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31795041
Citation
Zaehringer J, Ende G, Santangelo P, Kleindienst N, Ruf M, Bertsch K, Bohus M, Schmahl C, Paret C. Improved emotion regulation after neurofeedback: A single-arm trial in patients with borderline personality disorder. Neuroimage Clin. 2019;24:102032. doi: 10.1016/j.nicl.2019.102032. Epub 2019 Oct 16.
Results Reference
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A Neurofeedback Booster for Emotion Regulation Therapy
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