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

NCT ID: NCT03416764

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-13
• Study Completion Date: 2022-02-20

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.

Conditions

Posttraumatic Stress Disorder (PTSD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

EFP-NF (participants without steady menstrual cycle).

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

Group Type: EXPERIMENTAL

EFP-NF training

Intervention Type: 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.

TAU

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

EFP-NF during HIGH estrogen phase

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.

Group Type: EXPERIMENTAL

EFP-NF training

Intervention Type: 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 during LOW estrogen phase

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.

Group Type: EXPERIMENTAL

EFP-NF training

Intervention Type: 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.

Interventions

EFP-NF training

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.

Intervention Type: DEVICE

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. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 62 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miki Bloch, M.D.

Role: PRINCIPAL_INVESTIGATOR

TASMC Israel

Locations

Tel Aviv Sourasky Medical Center Tel Aviv, Israel

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Marina Gordon, BA

Role: CONTACT

marinago@tlvmc.gov.il

972-3-6973685

Liat Helpman, PhD

Role: CONTACT

liathe@tlvmc.go

972-3-6973685

Facility Contacts

Marina Gordon, BA

Role: primary

Other Identifiers

TAMC-17-MB-0696-CTIL

Identifier Type: OTHER

Identifier Source: secondary_id

0696-17-TLV

Identifier Type: -

Identifier Source: org_study_id