Clinical trial NCT03858933: Train Your Brain: Neurofeedback Intervention for PTSD
Official title: Train Your Brain: A Neurofeedback Intervention for Individuals With Post-Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: PTSD
Post-Traumatic Stress Disorder
Acute Stress Syndrome
Emotion Regulation
Depression
Anxiety
Sexual Assault
Combat PTSD
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2019-03-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline PTSD severity using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5
timeFrame: administered at Initial Appointment (Week 0) and one week after the 15th neurofeedback session (approximately Week 22).
Secondary outcomes:
measure: Emotion Regulation Questionnaire
timeFrame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
measure: Beck Depression Inventory
timeFrame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
measure: Beck Anxiety Inventory
timeFrame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
measure: PTSD Checklist for DSM-5
timeFrame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
measure: Sleep Duration
timeFrame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
measure: Emotional Stroop Task
timeFrame: administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University Of Southern California
state: California
Study officials:
affiliation: Faculty Professor
name: Jeremy Goldbach, PhD
role: PRINCIPAL_INVESTIGATOR
References: