Clinical trial NCT03416764: Estradiol-mediated Neural Plasticity as Potential Mediator of Neurofeedback Treatment Change for Traumatized Women
Official title: Estradiol-mediated Neural Plasticity as Potential Mediator of Neurofeedback Treatment Change for Traumatized Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
Keywords: PTSD, neurofeedback (NF)
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-01-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: Pretreatment phase- All participants will undergo clinician evaluation, self-report measures and emotional regulation tasks in TASMC. In addition, participants will undergo a functional and structural MRI to characterize brain network responses associated with emotional arousal and regulation.

Participants will be randomized to one of two arms: (1) NF-EFP group and treatment as usual at out-patient clinic (TAU) or (2) TAU (without EFP-NF). If participant has a steady menstrual cycle she will be randomized to one of three arms: (1) NF group administered during low estrogen phase (and maintain TAU); (2) NF group administered during high estrogen phase (and maintain TAU) or (3) TAU (without EFP-NF).

Treatment phase (10 weeks) EFP-NF training, twice a week for a total of 10 sessions. For participants with steady menstrual phase treatment will be administered NF during designated-estrogen phases (high or low).

Treatment as usual: Participants will obtain their regular treatment regimen (pharmacological and psychological) and meet with a psychologist/psychiatrist following the common practice in the clinic.

NF-EFP sessions: For the duration of each NF-EFP session the participant will be seated comfortably in front of a computer screen. A staff member will explain the goal of the meeting to the participant, present the equipment to be used and describe the course of the meeting. The EEG-NF practice will consist of four-minute segments repeated for up to 30 minutes. During each practice segment the participant will be asked to modify visual media that provides feedback on the degree of successful brain training. The duration of one session is approximately 45 minutes.

Post treatment phase -All participants will undergo clinician evaluation, self-report measures and emotional regulation tasks in TASMC. In addition, participants will undergo a functional and structural MRI to characterize brain network responses associated with emotional arousal and regulation.

Follow up- participants will be monitored by self-evaluation questionnaires post treatment.

Eligibility criteria: Inclusion Criteria:

Women of age (18-62) :

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

Exclusion Criteria:

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

Primary outcomes:
measure: Clinical measures- PSTD symptoms
timeFrame: 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:
measure: Changes in limbic system connectivity as measured by fMRI
timeFrame: fMRI will be administrated at pre-treatment (baseline) and post-treatment (up to two weeks post-treatment).
measure: Sleep quality- REM latency and sleep latency
timeFrame: 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).
measure: Emotional regulation choice task
timeFrame: Emotional regulation tasks will be administrated at pre-treatment (baseline) and post-treatment (up to two weeks post-treatment).
measure: Self-report questionnaires- PCL (PTSD checklist )
timeFrame: 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
measure: Self-report questionnaires- Beck Depression Inventory (BDI-II)
timeFrame: 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
measure: Self-report questionnaires- State-trait Anxiety Inventory (STAI)
timeFrame: 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
measure: Self-report questionnaires- Toronto Alexithymia Scale (TAS)
timeFrame: 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
measure: Self-report questionnaires- Dissociative Experience Scale (DES)
timeFrame: 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
measure: Self-report questionnaires- Locus of Control (LOC)
timeFrame: 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
measure: Emotional regulation stroop task
timeFrame: Emotional regulation tasks will be administrated at pre-treatment (baseline) and post-treatment (up to two weeks post-treatment).
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center Tel Aviv, Israel
Study officials:
affiliation: TASMC Israel
name: Miki Bloch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: