Train Your Brain: Neurofeedback Intervention for PTSD

University of Southern California

Status: Terminated

Conditions: Stress Disorders, Post-Traumatic

Treatments: Device: eBrainFit Platform

Study type: Interventional

Funder types: Other

Identifiers

NCT03858933

UP-16-00399-AM011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

Limbic Modulation Index Neurofeedback

Experimental group

Description:

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.

Treatment:

Device: eBrainFit Platform

Device: eBrainFit Platform

Alpha/Theta Neurofeedback

Active Comparator group

Description:

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.

Treatment:

Device: eBrainFit Platform

Device: eBrainFit Platform