Estradiol-mediated Neural Plasticity as Potential Mediator of Neurofeedback Treatment Change for Traumatized Women

NCT03416764 | Unknown DMC FDA Device

• 2 other identifiers: 0696-17-TLVTAMC-17-MB-0696-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 our 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 women with a history of childhood sexual abuse (CSA).

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

PTSD, neurofeedback (NF)

Outcome Measures

Primary Outcomes (1)

• Clinical measures- PSTD symptoms

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

  The clinical assessment will be administrated at pre-treatment (baseline) and post-treatment (up to two weeks post-treatment). Additional post-treatment measurements will be administrated at three follow-ups points; 1 month, 3 months and 6 months post

Secondary Outcomes (10)

• Changes in limbic system connectivity as measured by fMRI

  fMRI will be administrated at pre-treatment (baseline) and post-treatment (up to two weeks post-treatment).

• Sleep quality- REM latency and sleep latency

  Two nights; first, at pre-treatment (baseline) and second, post-treatment (up to two weeks post-treatment). A post-treatment evaluation will take place within two weeks post treatment (3-3.5 month since the beginning of the study).

• Emotional regulation choice task

  Emotional regulation tasks will be administrated at pre-treatment (baseline) and 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).and at three follow-ups points; 1 month, 3 months and 6 months post treatment

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

  The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment).and at three follow-ups points; 1 month, 3 months and 6 months post treatment

Study Arms (4)

EFP-NF (participants without steady menstrual cycle).

EXPERIMENTAL

EFP-NF training, twice a week for a total of 10 sessions .

Device: EFP-NF training

TAU

NO INTERVENTION

Participant will receive no EFP-NF training, and continue their treatment as usual (TAU).

EFP-NF during HIGH estrogen phase

EXPERIMENTAL

EFP-NF training, twice a week, during high-estrogen phases only (days 7-21 of a 28-day cycle), for a total of 10 sessions.

Device: EFP-NF training

EFP-NF during LOW estrogen phase

EXPERIMENTAL

EFP-NF training, twice a week, during low-estrogen phases only (days 21-28 of a cycle and days 1-7 of the following cycle,based on a 28-day cycle), for a total of 10 sessions.

Device: EFP-NF training

Interventions

EFP-NF training DEVICE

Experimental groups (among participants with and without steady menstrual cycle) will receive a total of 10 training sessions during 10 weeks. In addition to EFP-NF training, participants in the experimental groups will continue to be treated as usual at Clinic for Sexual Assault.

EFP-NF (participants without steady menstrual cycle).; EFP-NF during HIGH estrogen phase; EFP-NF during LOW estrogen phase

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women of age (18-62) :
• Treated at Clinic for Sexual Assault with stable symptoms.
• Fulfill screening criteria of DSM-V for PTSD. -

You may not qualify if:

• Pregnancy.
• 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

Study Sites (1)

Tel Aviv Sourasky Medical Center Tel Aviv, Israel

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Miki Bloch, M.D.

  TASMC Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Gordon, BA

CONTACT

972-3-6973685; marinago@tlvmc.gov.il

Liat Helpman, PhD

CONTACT

972-3-6973685; liathe@tlvmc.go

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant is aware of treatment group (NF or TAU) Participant is unaware of allocation to treatment estrogen phases (high or low) Investigator and outcome assessor are unaware of group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 31, 2018
• Study Start: January 13, 2019
• Primary Completion: February 20, 2022
• Study Completion: February 20, 2022
• Last Updated: February 5, 2019

Record last verified: 2019-01

Locations

IL (1)