Neurofeedback in Adolescents With Emotion Dysregulation
EFPTest
Proof-of-concept and Validity of Amygdala-neurofeedback in Adolescent Patients With Emotion Dysregulation
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2018
CompletedFirst Submitted
Initial submission to the registry
May 22, 2019
CompletedFirst Posted
Study publicly available on registry
May 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMarch 7, 2022
March 1, 2022
2.9 years
May 22, 2019
March 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Change from baseline to 5 weeks
Secondary Outcomes (1)
Alexithymia
Change from baseline to 5 weeks
Study Arms (2)
EFP neurofeedback
EXPERIMENTALTen 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.
Treatment as usual
NO INTERVENTIONLike patients from the treatment arm, these patients are on current residential treatment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Central Institute of Mental Health, Mannheimlead
- Tel Aviv Universitycollaborator
Study Sites (1)
Central Institute of Mental Health
Mannheim, 68159, Germany
Related Publications (6)
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.
PMID: 30932053BACKGROUNDKeynan 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.
PMID: 26996601BACKGROUNDMeir-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.
PMID: 27163677BACKGROUNDParet 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.
PMID: 26833918BACKGROUNDNicholson 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.
PMID: 27647695BACKGROUNDLubianiker 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.
PMID: 30988481BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paret
Central Institute of Mental Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 22, 2019
First Posted
May 28, 2019
Study Start
May 14, 2018
Primary Completion
March 30, 2021
Study Completion
December 31, 2021
Last Updated
March 7, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share