Train Your Brain: Neurofeedback Intervention for PTSD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Train Your Brain: A Neurofeedback Intervention for Individuals With Post-Traumatic Stress Disorder

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Device: eBrainFit Platform
* Device: eBrainFit Platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous diagnosis of PTSD PTSD symptoms within the last 30 days Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Limbic Modulation Index Neurofeedback<br>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. | Device: eBrainFit Platform<br>* Amygdala regulation with eyes open<br>|
| Active Comparator: Alpha/Theta Neurofeedback<br>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. | Device: eBrainFit Platform<br>* Alpha/Theta regulation with eyes open<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | administered at Initial Appointment (Week 0) and one week after the 15th neurofeedback session (approximately Week 22). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Post-Traumatic Stress Disorder, Acute Stress Syndrome, Emotion Regulation, Depression, Anxiety, Sexual Assault, Combat PTSD