Stress Disorders, Post-TraumaticNCT03858933
Train Your Brain: Neurofeedback Intervention for PTSD
A study testing eBrainFit Platform in people with Stress Disorders, Post-Traumatic, run by University of Southern California at 1 site in United States.
Trial summary
The investigator's aim is to evaluate the efficacy of two types of neurofeedback treatments for PTSD symptoms reduction. Half of the participants will receive the current standard for PTSD neurofeedback care undergoing alpha/theta neurofeedback regulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- eBrainFit Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2018to 31 Dec 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous diagnosis of PTSD
- PTSD symptoms within the last 30 days
Who cannot join
- Any active psychosis or suicidal intent
- A severe traumatic brain injury (one in which consciousness was lost for greater than 6 hours)
- Any of the following neurological disorders: Parkinson's, Alzheimer's, Brain Tumor, or Brain Lesion.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Southern California
Los Angeles, California, 90089
About this study
Official title: Train Your Brain: A Neurofeedback Intervention for Individuals With Post-Traumatic Stress Disorder
The investigator's aim is to evaluate the efficacy of two types of neurofeedback treatments for PTSD symptoms reduction. Half of the participants will receive the current standard for PTSD neurofeedback care undergoing alpha/theta neurofeedback regulation. The other half will receive the newly developed limbic modulation index neurofeedback.
Read the detailed description
Traumatic stress is commonly resistant to existing therapeutics, possibly due to high treatment dropout rates along with a failure to target the relevant underlying neural mechanisms. Neuromodulation of deep limbic areas such as the amygdala may play a critical role in the effective recovery from traumatic stress. Human studies have shown the importance of such modulation during the encoding of traumatic stimuli, showing greater amygdala activation for subsequently remembered traumatic stimuli. In addition, a prospective study among previously healthy soldiers showed that hyper-activation of the amygdala prior to military traumatic exposure corresponded with more severe post-traumatic symptoms following exposure.
Together these finding points to the amygdala as a plausible neuromodulation target for preventive or early interventions of post-traumatic disturbances. Local neuromodulation of the amygdala could improve treatment specificity and the overall intervention outcome.
The main goal of the suggested research is to further develop and implement a non-invasive, portable and cost-effective brain-imaging tool that will provide individual on-line guidance for amygdala modulation. This closed-loop brain training will enhance individual resilience to and coping with potentially traumatic stress as well as alleviate consequential psychopathologies.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- eBrainFit Platform
- Keywords
- PTSD, Post-Traumatic Stress Disorder, Acute Stress Syndrome, Emotion Regulation, Depression, Anxiety, Sexual Assault, Combat PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic, Emotional Regulation, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eBrainFit PlatformDevice
Alpha/Theta regulation with eyes open
eBrainFit PlatformDevice
Amygdala regulation with eyes open
| Study group | Role | What they receive |
|---|---|---|
| Limbic Modulation Index Neurofeedback | Experimental | This arm of the study will undergo a novel neurofeedback treatment, targeting downregulation of deep limbic structures, specifically the amygdalae.
Participants in this arm will complete 15 neurofeedback sessions. Receives: Device: eBrainFit Platform |
| Alpha/Theta Neurofeedback | Active comparator | This arm of the study will undergo a proven PTSD neurofeedback treatment, alpha/theta regulation, during which participants will try various mental strategies to increase the presence of theta waves.
Participants in this arm will complete 15 neurofeedback sessions. Receives: Device: eBrainFit Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline PTSD severity using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5
The five-point CAPS-5 symptom severity rating scale is used for all symptoms. Rating scale anchors should be interpreted and used as follows:
0 Absent The respondent denied the problem or the respondent's report doesn't fit the DSM-5 symptom criterion.
- Mild / subthreshold:
- Moderate / threshold:
- Severe / markedly elevated:
- Extreme / incapacitating:
CAPS-5 total symptom severity score is calculated by summing severity scores for items 1-20.
CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms contained in a given DSM-5 cluster.
Measured: administered at Initial Appointment (Week 0) and one week after the 15th neurofeedback session (approximately Week 22).
Secondary outcomes (6)
Emotion Regulation Questionnaire
A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).
Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet. Items 2, 4, 6, 9 make up the Expressive Suppression facet. Scoring is kept continuous. Each facet's scoring is kept separate.
Measured: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
Beck Depression Inventory
Quantifies depressive symptoms using a 21-item measure.
Depression severity is calculated by summing the score responses, with higher values indicating more severe symptom expression.
Measured: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
Beck Anxiety Inventory
Quantifies anxious symptoms using a 21-item measure
Anxiety severity is calculated by summing the score responses, with higher values indicating more severe symptom expression.
Measured: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
PTSD Checklist for DSM-5
Quantifies PTSD symptoms using a 20-item measure
PTSD severity is calculated by summing the score responses, with higher values indicating more severe symptom expression.
Measured: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
Sleep Duration
Captured using a Fitbit Physical Activity Tracking Device
The device will report the participant's sleep duration (output in minutes) for each night the device is worn.
Measured: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
Emotional Stroop Task
Behavioral metric of conflict adaptation.
Emotion regulation will be assessed using a well-established emotional conflict paradigm that arises from an incompatibility between the task-relevant and task-irrelevant emotional dimensions of a stimulus and allows for the tracking of emotion regulation from trial to trial. In this task there is less conflict, indexed by faster reaction times for incongruent trials, than if they are preceded by a congruent trial. This difference in reaction times between low conflict resolution and high conflict resolution trials serves as a behavioral metric of conflict adaptation. A negative adaptation score reflects activation of a regulatory mechanism that leads to improved emotional conflict resolution.
Measured: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start19 Apr 2018
- Primary completion14 Mar 2020
- Study completion31 Dec 2020
Why it stopped: COVID-19 Regulations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, Jeremy Goldbach, University of Southern California
- Investigators
- Jeremy Goldbach, PhD, Principal investigator, Faculty Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858933
- Sponsor's protocol ID
- UP-16-00399-AM011
- Status last verified
- Aug 2021
- First submitted
- 16 Nov 2018
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Train Your Brain: A Neurofeedback Intervention for Individuals With Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT03858933
- Acronym / sponsor ID
- UP-16-00399-AM011
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- PTSD, Post-Traumatic Stress Disorder, Acute Stress Syndrome, Emotion Regulation, Depression, Anxiety, Sexual Assault, Combat PTSD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 Regulations
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 14 Mar 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Mar 2019 (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.
The investigator's aim is to evaluate the efficacy of two types of neurofeedback treatments for PTSD symptoms reduction. Half of the participants will receive the current standard for PTSD neurofeedback care undergoing alpha/theta neurofeedback regulation. The other half will receive the newly developed limbic modulation index neurofeedback.
Detailed description
Traumatic stress is commonly resistant to existing therapeutics, possibly due to high treatment dropout rates along with a failure to target the relevant underlying neural mechanisms. Neuromodulation of deep limbic areas such as the amygdala may play a critical role in the effective recovery from traumatic stress. Human studies have shown the importance of such modulation during the encoding of traumatic stimuli, showing greater amygdala activation for subsequently remembered traumatic stimuli. In addition, a prospective study among previously healthy soldiers showed that hyper-activation of the amygdala prior to military traumatic exposure corresponded with more severe post-traumatic symptoms following exposure.
Together these finding points to the amygdala as a plausible neuromodulation target for preventive or early interventions of post-traumatic disturbances. Local neuromodulation of the amygdala could improve treatment specificity and the overall intervention outcome.
The main goal of the suggested research is to further develop and implement a non-invasive, portable and cost-effective brain-imaging tool that will provide individual on-line guidance for amygdala modulation. This closed-loop brain training will enhance individual resilience to and coping with potentially traumatic stress as well as alleviate consequential psychopathologies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limbic Modulation Index Neurofeedback | Experimental | Device: eBrainFit PlatformThis arm of the study will undergo a novel neurofeedback treatment, targeting downregulation of deep limbic structures, specifically the amygdalae. Participants in this arm will complete 15 neurofeedback sessions. |
| Alpha/Theta Neurofeedback | Active comparator | Device: eBrainFit PlatformThis arm of the study will undergo a proven PTSD neurofeedback treatment, alpha/theta regulation, during which participants will try various mental strategies to increase the presence of theta waves. Participants in this arm will complete 15 neurofeedback sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previous diagnosis of PTSD
- PTSD symptoms within the last 30 days
Key exclusion criteria (3 listed)
- Any active psychosis or suicidal intent
- A severe traumatic brain injury (one in which consciousness was lost for greater than 6 hours)
- Any of the following neurological disorders: Parkinson's, Alzheimer's, Brain Tumor, or Brain Lesion.
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 |
|---|---|---|
| eBrainFit PlatformAlpha/Theta regulation with eyes open | Device | Alpha/Theta Neurofeedback |
| eBrainFit PlatformAmygdala regulation with eyes open | Device | Limbic Modulation Index Neurofeedback |
Primary outcome
Change from baseline PTSD severity using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5
Time frame: administered at Initial Appointment (Week 0) and one week after the 15th neurofeedback session (approximately Week 22).
The five-point CAPS-5 symptom severity rating scale is used for all symptoms. Rating scale anchors should be interpreted and used as follows: 0 Absent The respondent denied the problem or the respondent's report doesn't fit the DSM-5 symptom criterion. 1. Mild / subthreshold: 2. Moderate / threshold: 3. Severe / markedly elevated: 4. Extreme / incapacitating: CAPS-5 total symptom severity score is calculated by summing severity scores for items 1-20. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms contained in a given DSM-5 cluster.
6 secondary outcomes
Emotion Regulation Questionnaire
Time frame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
Beck Depression Inventory
Time frame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
Beck Anxiety Inventory
Time frame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
PTSD Checklist for DSM-5
Time frame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
Sleep Duration
Time frame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
Emotional Stroop Task
Time frame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
Results and safety
The study was stopped early (reason given: COVID-19 Regulations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Online Eligibility SurveyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Jeremy Goldbach, PhD principal investigator
Faculty Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eBrainFit Platform in people with Stress Disorders, Post-Traumatic, run by University of Southern California at 1 site in United States.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 27 Aug 2021. 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 United States. 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?
The study was stopped early (reason given: COVID-19 Regulations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline PTSD severity using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5 (time frame: administered at Initial Appointment (Week 0) and one week after the 15th neurofeedback session (approximately Week 22).). 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 27 Aug 2021.