Regulation of Amygdala Via Neurofeedback in PTSD After Childhood Sexual Abuse

NCT04303533 | Unknown FDA Device

• 1 other identifier: 0576-18
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

Post-traumatic stress disorder (PTSD) is a common debilitating disorder that affects many individuals exposed to aversive events. The severity of PTSD symptoms is positively correlated with amygdala activation. More severe PTSD symptoms following exposure to stressful events, are associated with amygdala hyper-responsivity prior to exposure. A possible intervention for PTSD is Neurofeedback (NF) - a treatment method based on learned self-modulation of neural activity in response to feedback of neural signal. Previous work in the investigator's lab established a NF training procedure that utilizes the temporal abilities of EEG with the spatial advantages of fMRI. Further work based on this method using the amygdala BOLD signal (EEG-finger-print, EFP) has demonstrated a potential for improving the ability to self-regulate amygdala activity and to improve emotional regulation in a healthy population. The current study aims to investigate the potential of this method as a therapeutic intervention for PTSD among men with a history of childhood sexual abuse (CSA).

Conditions

PTSD

Keywords

Neuro-Feedback; Childhood Sexual Abuse

Outcome Measures

Primary Outcomes (1)

• Clinical measures- PSTD symptoms

  Change in PTSD symptoms measured by change in Clinician-Administered PTSD Scale (CAPS)

  [ Time Frame: The clinical assessment will be administrated at pre-treatment (baseline) and post-treatment (up to two weeks post-treatment)

Secondary Outcomes (7)

• Sleep quality- REM latency and sleep latency

  [ Time Frame: Two nights; first, at pre-treatment (baseline) and second, post-treatment (up to two weeks post-treatment).

• Self-report questionnaires- PCL (PTSD checklist )

  The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment).

• self-report questionnaires- Beck Depression Inventory (BDI-II)

  Time Frame: The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment).

• Self-report questionnaires- State-trait Anxiety Inventory (STAI)

  Time Frame: The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment).

• Self-report questionnaires- Toronto Alexithymia Scale (TAS)

  Time Frame: The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment)

Study Arms (1)

EFP-NF

EXPERIMENTAL

Device: Neuro-Feedback EFP

Interventions

Neuro-Feedback EFP DEVICE

Neurofeedback (NF) - is a treatment method based on learned self-modulation of neural activity in response to feedback of neural signal. Amygdala-EFP (EEG-finger-print, EFP) is an EEG-NF application that modulates amygdala response.

EFP-NF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treated at Clinic for Sexual Assault with stable symptoms. Fulfill screening criteria of DSM-V for PTSD.

You may not qualify if:

• Fulfill screening criteria of DSM-V for psychosis. Substance dependence or abuse other than nicotine. Diagnosis of a neurodegenerative disease. Acute illness that could be worsen by the treatment. -

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Tel Aviv University: collaborator

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 11, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share