A Neurofeedback Booster for Emotion Regulation Therapy

Borderline Personality Disorder Clinical Trial

— BrainBoost  

Official title:

BrainBoost - A Neurofeedback Booster for Emotion Regulation Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04333888
• Other study ID #: 2020-513N
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: May 2023

Study information

• Verified date: March 2022
• Source: Central Institute of Mental Health, Mannheim
• Contact: Christian Paret, Dr. sc. hum.
• Phone: (+49) 621 - 1703-4462
• Email: christian.paret[@]zi-mannheim.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• Neurofeedback
fMRI neurofeedback training of amygdala downregulation

Locations

Country	Name	City	State
Germany	Central Institute of Mental Health	Mannheim

Sponsors (3)

Lead Sponsor	Collaborator
Christian Paret	AE Foundation, Yale University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before treatment, immediately after treatment + follow-up measure (3 months)
Secondary	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.	Before treatment, immediately after treatment + follow-up measure (3 months)
Secondary	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.	Before treatment, immediately after treatment + 2 follow-up measures (3 months, 6 months)
Secondary	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.	Before treatment, immediately after treatment + follow-up measure (3 months)
Secondary	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.	Before treatment, immediately after treatment + follow-up measure (3 months)
Secondary	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)	Before the first neurofeedback training and after the last neurofeedback training