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A Neurofeedback Booster for Emotion Regulation Therapy

BrainBoost - A Neurofeedback Booster for Emotion Regulation Therapy

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04333888
Acronym
BrainBoost
Enrollment
44
Registered
2020-04-03
Start date
2020-07-21
Completion date
2025-12-31
Last updated
2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder

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.

Interventions

BEHAVIORALNeurofeedback

fMRI neurofeedback training of amygdala downregulation

Sponsors

Yale University
CollaboratorOTHER
AE Foundation
CollaboratorOTHER
Christian Paret
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in affective instabilityBefore treatment, immediately after treatment + follow-up measure (3 months)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

MeasureTime frameDescription
Change in emotion regulationBefore treatment, immediately after treatment + follow-up measure (3 months)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 symptomatologyBefore treatment, immediately after treatment + 2 follow-up measures (3 months, 6 months)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 connectivityBefore treatment, immediately after treatment + follow-up measure (3 months)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 reactivityBefore treatment, immediately after treatment + follow-up measure (3 months)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 brainBefore the first neurofeedback training and after the last neurofeedback trainingBy including DTI sequences before and after the neurofeedback intervention, we want to explore changes in FA/fiber structure of the brain. (exploratory analysis)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026