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Neurofeedback in Adolescents With Emotion Dysregulation (EFPTest)

Primary Purpose

Emotional Disturbances

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
neurofeedback
Sponsored by
Central Institute of Mental Health, Mannheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emotional Disturbances focused on measuring Borderline, Post-traumatic stress, Neurofeedback, Amygdala, Emotion regulation

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female patients will be included with four or more BPD and/or PTSD criteria (DSM-5)
  • Willingness to participate in the study
  • On residential treatment at adolescence center (Central Institute of Mental Health) throughout the study, including assessment of transfer.

Exclusion Criteria:

  • General Pharmacological therapy with benzodiazepines
  • Substance use
  • Pregnancy
  • Eplilepsy, traumatic brain injury, brain tumor or otherwise severe neurological or medical history
  • BMI > 16.5
  • Non-removable electrical implants
  • Non-removable ferrous metal implants Permanent make-up and tattoos
  • Claustrophobia

Sites / Locations

  • Central Institute of Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EFP neurofeedback

Treatment as usual

Arm Description

Ten sessions of EFP neurofeedback training. EEG is picked up with scalp electrodes, processed in real-time and returned to patients. One session lasts 30 min.

Like patients from the treatment arm, these patients are on current residential treatment.

Outcomes

Primary Outcome Measures

Amygdala self-regulation
Amygdala BOLD regulation is assessed in a transfer task. Transfer task: Two 60s-blocks of BOLD fMRI neurofeedback (visual thermometer) with instruction to down-regulate.

Secondary Outcome Measures

Alexithymia
Impaired cognitive processing of emotion, assessed via questionnaire TAS-26, score range: 0-130 (higher score indicates higher alexithymia)

Full Information

First Posted
May 22, 2019
Last Updated
March 4, 2022
Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT03964545
Brief Title
Neurofeedback in Adolescents With Emotion Dysregulation
Acronym
EFPTest
Official Title
Proof-of-concept and Validity of Amygdala-neurofeedback in Adolescent Patients With Emotion Dysregulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
Tel Aviv University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A treatment to improve emotion regulation is tested in young patients with trauma-related mental disorder. The Electrical FingerPrint (EFP) from the amygdala is used for presenting patients with feedback (i.e. neurofeedback) from the amygdala, a brain region which plays a critical role in emotion and mental disorder. Via feedback, patients learn to self-regulate the neural circuit of emotion.
Detailed Description
The study tests a neurofeedback treatment for emotion regulation training in adolescent patients suffering from emotional disturbances, indicated by diagnosis with borderline personality disorder (BPD) and/or post-traumatic stress disorder (PTSD), using innovative Electric Finger-Print (EFP) technology. With neurofeedback, patients can learn to regulate brain activation from emotion brain circuit. The technique allows neurofeedback training of sub-cortical brain activation outside the brain scanner, using an electroencephalography (EEG) surrogate of amygdala activation. The novel approach combines the advantages of functional magnetic resonance imaging (fMRI, i.e. high spatial resolution) and EEG (high scalability). EFP allows the probing of deep brain signals with scalp-electrodes, thus bridging a technological gap in neurofeedback training. The developers used EEG feature extraction and machine learning to receive model coefficients (i.e. the EFP) predicting amygdala BOLD activation based on EEG-channel activity (see Citations in this registration). Participation in this trial is offered to patients who receive residential treatment at the adolescence center of the Central Institute of Mental Health (Mannheim, Germany) to obtain proof-of-concept in this special population, and to show potential value of adjuvant neurofeedback treatment. Patients in the treatment group receive 10 neurofeedback sessions within 5 weeks. Transfer is assessed with neural and questionnaire measures afterwards. A treatment-as-usual (TAU) control group does not receive the neurofeedback. We expect to replicate correlation of EFP with the blood oxygenation level dependent (BOLD) signal from the amygdala, which is tested via simultaneous fMRI-EEG data acquisition post-treatment. Additionally, we assume improved amygdala-BOLD regulation in an fMRI neurofeedback test. This study aims to extend proof-of-concept of EFP neurofeedback to an adolescent population suffering from severe emotional disturbances.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Disturbances
Keywords
Borderline, Post-traumatic stress, Neurofeedback, Amygdala, Emotion regulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EFP neurofeedback
Arm Type
Experimental
Arm Description
Ten sessions of EFP neurofeedback training. EEG is picked up with scalp electrodes, processed in real-time and returned to patients. One session lasts 30 min.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Like patients from the treatment arm, these patients are on current residential treatment.
Intervention Type
Behavioral
Intervention Name(s)
neurofeedback
Intervention Description
Patients are instructed to reduce amygdala activation by means of down-regulating the EFP. An auditory feedback interface is used with the instruction to down-regulate volume of a jingle, reflecting intensity of EFP.
Primary Outcome Measure Information:
Title
Amygdala self-regulation
Description
Amygdala BOLD regulation is assessed in a transfer task. Transfer task: Two 60s-blocks of BOLD fMRI neurofeedback (visual thermometer) with instruction to down-regulate.
Time Frame
Change from baseline to 5 weeks
Secondary Outcome Measure Information:
Title
Alexithymia
Description
Impaired cognitive processing of emotion, assessed via questionnaire TAS-26, score range: 0-130 (higher score indicates higher alexithymia)
Time Frame
Change from baseline to 5 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients will be included with four or more BPD and/or PTSD criteria (DSM-5) Willingness to participate in the study On residential treatment at adolescence center (Central Institute of Mental Health) throughout the study, including assessment of transfer. Exclusion Criteria: General Pharmacological therapy with benzodiazepines Substance use Pregnancy Eplilepsy, traumatic brain injury, brain tumor or otherwise severe neurological or medical history BMI > 16.5 Non-removable electrical implants Non-removable ferrous metal implants Permanent make-up and tattoos Claustrophobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paret
Organizational Affiliation
Central Institute of Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Institute of Mental Health
City
Mannheim
ZIP/Postal Code
68159
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30932053
Citation
Keynan JN, Cohen A, Jackont G, Green N, Goldway N, Davidov A, Meir-Hasson Y, Raz G, Intrator N, Fruchter E, Ginat K, Laska E, Cavazza M, Hendler T. Electrical fingerprint of the amygdala guides neurofeedback training for stress resilience. Nat Hum Behav. 2019 Jan;3(1):63-73. doi: 10.1038/s41562-018-0484-3. Epub 2018 Dec 10. Erratum In: Nat Hum Behav. 2019 Feb;3(2):194.
Results Reference
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PubMed Identifier
26996601
Citation
Keynan JN, Meir-Hasson Y, Gilam G, Cohen A, Jackont G, Kinreich S, Ikar L, Or-Borichev A, Etkin A, Gyurak A, Klovatch I, Intrator N, Hendler T. Limbic Activity Modulation Guided by Functional Magnetic Resonance Imaging-Inspired Electroencephalography Improves Implicit Emotion Regulation. Biol Psychiatry. 2016 Sep 15;80(6):490-496. doi: 10.1016/j.biopsych.2015.12.024. Epub 2016 Jan 6.
Results Reference
background
PubMed Identifier
27163677
Citation
Meir-Hasson Y, Keynan JN, Kinreich S, Jackont G, Cohen A, Podlipsky-Klovatch I, Hendler T, Intrator N. One-Class FMRI-Inspired EEG Model for Self-Regulation Training. PLoS One. 2016 May 10;11(5):e0154968. doi: 10.1371/journal.pone.0154968. eCollection 2016.
Results Reference
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PubMed Identifier
26833918
Citation
Paret C, Kluetsch R, Zaehringer J, Ruf M, Demirakca T, Bohus M, Ende G, Schmahl C. Alterations of amygdala-prefrontal connectivity with real-time fMRI neurofeedback in BPD patients. Soc Cogn Affect Neurosci. 2016 Jun;11(6):952-60. doi: 10.1093/scan/nsw016. Epub 2016 Feb 1.
Results Reference
background
PubMed Identifier
27647695
Citation
Nicholson AA, Rabellino D, Densmore M, Frewen PA, Paret C, Kluetsch R, Schmahl C, Theberge J, Neufeld RW, McKinnon MC, Reiss J, Jetly R, Lanius RA. The neurobiology of emotion regulation in posttraumatic stress disorder: Amygdala downregulation via real-time fMRI neurofeedback. Hum Brain Mapp. 2017 Jan;38(1):541-560. doi: 10.1002/hbm.23402. Epub 2016 Sep 20.
Results Reference
background
PubMed Identifier
30988481
Citation
Lubianiker N, Goldway N, Fruchtman-Steinbok T, Paret C, Keynan JN, Singer N, Cohen A, Kadosh KC, Linden DEJ, Hendler T. Process-based framework for precise neuromodulation. Nat Hum Behav. 2019 May;3(5):436-445. doi: 10.1038/s41562-019-0573-y. Epub 2019 Apr 15. Erratum In: Nat Hum Behav. 2019 Apr 30;: Nat Hum Behav. 2019 Jul;3(7):760.
Results Reference
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Links:
URL
https://osf.io/6zds5
Description
Parallel OSF registration

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Neurofeedback in Adolescents With Emotion Dysregulation

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