Posttraumatic Stress Disorder (PTSD)NCT03416764
Estradiol-mediated Neural Plasticity as Potential Mediator of Neurofeedback Treatment Change for Traumatized Women
A study testing EFP-NF training in people with Posttraumatic Stress Disorder (PTSD), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 62 years, women only
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- EFP-NF training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Jan 2019to 20 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 62 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women of age (18-62) :
- Treated at Clinic for Sexual Assault with stable symptoms.
- Fulfill screening criteria of DSM-V for PTSD. -
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center Tel Aviv, Israel
Tel Aviv
Marina Gordon, BA
About this study
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).
Read the 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)
- Being tested
- EFP-NF training
- Keywords
- PTSD, neurofeedback (NF)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFP-NF trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EFP-NF (participants without steady menstrual cycle). | Experimental | EFP-NF training, twice a week for a total of 10 sessions . Receives: 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. Receives: 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. Receives: Device: EFP-NF training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical measures- PSTD symptoms
Change in PTSD symptoms measured by change in Clinician-Administered PTSD Scale (CAPS)
Measured: 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
Using fMRI, specific changes in limbic system connectivity will be assessed. Changes in areas in the PFC and limbic regions, all will be measured at post- vs. pre-treatment times
Measured: fMRI will be administrated at pre-treatment (baseline) and post-treatment (up to two weeks post-treatment).
Sleep quality- REM latency and sleep latency
WatchPAT (wearable technology) will track REM latency and sleep latency . These will be compared and corrected using MANOVA as an outcome analysis. To assess sleep globally, we will aggregated: increased sleep latency , reduced sleep efficiency (the ratio of the total time spent asleep compared to the total amount of time spent in bed) and lack of proper deep sleep (quantified using "deep sleep percent" and "REM sleep percent", i.e. the ratio of the total time spent in deep/REM sleep out of the total sleep time) into one reported value. For full explanation and calculation of index see Goldway, et al. (2019).
Measured: 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
Behavioral - emotional regulation choice task. A computer-based task designed by Sheppes et al. (2011) was used to assess participants'choice between distraction and reappraisal when facing negatively valenced stimuli.
Measured: 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 )
A self-report measure (20 items) of PTSD symptoms reflecting the diagnostic criteria of DSM 4+5. The self-report rating scale is 0-4 for each symptom, Rating scale descriptors are: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) is obtained by summing the scores for each of the items, higher values represent more severe PTSD. Symptom cluster severity scores is obtained by summing the scores for the items within a given cluster, i.e. for DSM 5: cluster B (items 1-5), cluster C (items 6-7), cluster D (items 8-14), and cluster E (items 15-20).
Measured: 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)
A 21 item self-administered inventory of depression symptoms and their respective intensity. BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. higher values represent more severe depression.
Measured: 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- State-trait Anxiety Inventory (STAI)
A 20 item self-administered inventory of state and trait anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). SUM of scores is obtained, higher scores indicate greater anxiety.
Measured: 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- Toronto Alexithymia Scale (TAS)
20 items self-administered composing the alexithymia scale. The TAS-20 has 3 sub-scales: Difficulty Describing Feelings subscale is used to measure difficulty describing emotions. Difficulty Identifying Feeling subscale is used to measure difficulty identifying emotions. Externally-Oriented Thinking subscale is used to measure the tendency of individuals to focus their attention externally. Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree. The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. Higher scores represent higher alexithymia rate.
Measured: 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- Dissociative Experience Scale (DES)
28-item self-administered measure of frequency of dissociative experiences. higher DES scores indicate higher dissociative rates.
Measured: 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- Locus of Control (LOC)
24 items self-administered questionnaire intended to measure internal versus external locus of control
Measured: 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
Emotional regulation stroop task
emotional Stroop- emotional regulation task, participants viewed fearful or happy facial expressions with superimposed congruent or incongruent words (happy\fear) and were asked to identify the emotional expression while ignoring the words.
Measured: Emotional regulation tasks will be administrated at pre-treatment (baseline) and post-treatment (up to two weeks post-treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start13 Jan 2019
- Primary completion20 Feb 2022 (estimated)
- Study completion20 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Miki Bloch, M.D., Principal investigator, TASMC Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416764
- Sponsor's protocol ID
- 0696-17-TLV
- Other IDs
- TAMC-17-MB-0696-CTIL
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estradiol-mediated Neural Plasticity as Potential Mediator of Neurofeedback Treatment Change for Traumatized Women
- ClinicalTrials.gov ID
- NCT03416764
- Acronym / sponsor ID
- 0696-17-TLV
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- PTSD, neurofeedback (NF)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 13 Jan 2019 (actual)
- Primary completion
- 20 Feb 2022 (estimated)
- Study completion
- 20 Feb 2022 (estimated)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EFP-NF (participants without steady menstrual cycle). | Experimental | Device: EFP-NF trainingEFP-NF training, twice a week for a total of 10 sessions . |
| TAU | No intervention | –Participant will receive no EFP-NF training, and continue their treatment as usual (TAU). |
| EFP-NF during HIGH estrogen phase | Experimental | Device: EFP-NF trainingEFP-NF training, twice a week, during high-estrogen phases only (days 7-21 of a 28-day cycle), for a total of 10 sessions. |
| EFP-NF during LOW estrogen phase | Experimental | Device: EFP-NF trainingEFP-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. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Treated at Clinic for Sexual Assault with stable symptoms.
- Fulfill screening criteria of DSM-V for PTSD. -
Key exclusion criteria (5 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EFP-NF trainingExperimental 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. | Device | EFP-NF (participants without steady menstrual cycle)., EFP-NF during HIGH estrogen phase, EFP-NF during LOW estrogen phase |
Primary outcome
Clinical measures- PSTD symptoms
Time frame: 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
Change in PTSD symptoms measured by change in Clinician-Administered PTSD Scale (CAPS)
10 secondary outcomes
Changes in limbic system connectivity as measured by fMRI
Time frame: fMRI will be administrated at pre-treatment (baseline) and post-treatment (up to two weeks post-treatment).
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). 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
Time frame: 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 )
Time frame: 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)
Time frame: 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- 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).and at three follow-ups points; 1 month, 3 months and 6 months 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).and at three follow-ups points; 1 month, 3 months and 6 months post treatment
Self-report questionnaires- Dissociative Experience Scale (DES)
Time frame: 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- Locus of Control (LOC)
Time frame: 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
Emotional regulation stroop task
Time frame: Emotional regulation tasks will be administrated at pre-treatment (baseline) and post-treatment (up to two weeks post-treatment).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miki Bloch, M.D. principal investigator
TASMC Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EFP-NF training in people with Posttraumatic Stress Disorder (PTSD), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Gordon, BA (972-3-6973685, marinago@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical measures- PSTD symptoms (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.