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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Posttraumatic Stress Disorder (PTSD)

Treatments: Device: EFP-NF training

Study type: Interventional

Funder types: Other

Identifiers

NCT03416764

TAMC-17-MB-0696-CTIL (Other Identifier)

0696-17-TLV

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 62 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 4 patient groups

EFP-NF (participants without steady menstrual cycle).

Experimental group

Description:

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

Treatment:

Device: EFP-NF training

TAU

No Intervention group

Description:

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

EFP-NF during HIGH estrogen phase

Experimental group

Description:

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.

Treatment:

Device: EFP-NF training

EFP-NF during LOW estrogen phase

Experimental group

Description:

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.

Treatment:

Device: EFP-NF training