Train Your Brain: Neurofeedback Intervention for PTSD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-19

Study Completion Date

2020-12-31

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.

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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.

Conditions

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Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The eBrainFit Platform is set to randomize each entered Subject Identification Number into either the alpha/theta or limbic modulation treatment arms. Neither the participant nor researcher will know the arm, to which the participant has been assigned.

Study Groups

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Limbic Modulation Index Neurofeedback

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.

Group Type EXPERIMENTAL

eBrainFit Platform

Intervention Type DEVICE

Amygdala regulation with eyes open

Alpha/Theta Neurofeedback

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.

Group Type ACTIVE_COMPARATOR

eBrainFit Platform

Intervention Type DEVICE

Alpha/Theta regulation with eyes open

Interventions

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eBrainFit Platform

Alpha/Theta regulation with eyes open

Intervention Type DEVICE

eBrainFit Platform

Amygdala regulation with eyes open

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No