Train Your Brain: Neurofeedback Intervention for PTSD

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03858933
• Other study ID #: UP-16-00399-AM011
• Status: Terminated
• Phase: N/A
• Start date: April 19, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2021
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The other half will receive the newly developed limbic modulation index neurofeedback.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: December 31, 2020
• Est. primary completion date: March 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• eBrainFit Platform
Alpha/Theta regulation with eyes open
• eBrainFit Platform
Amygdala regulation with eyes open

Locations

Country	Name	City	State
United States	University Of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Tel Aviv University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Online Eligibility Survey