Self-regulation of Prefrontal Cortex During Emotional Cognitive Control in PTSD (SPrC-PTSD)

Deficits in emotional cognitive control are present in a number of clinical psychiatric populations including depression, anxiety, and PTSD. Deficits in this domain of function limit one's ability to focus attention on goal-directed activities while inhibiting reactions to irrelevant emotional stimuli, and this contributes to the symptoms of these disorders and makes individuals less likely to be successful in existing treatments. The left dorsolateral prefrontal cortex (LDLPFC) and its connectivity with other regions (i.e., dorsal anterior cingulate cortex, ventromedial prefrontal cortex, insula, amygdala) is thought to play a central role in facilitating emotional cognitive control. However, past research has primarily utilized correlational approaches that limit conclusions about the directionality of these relationships. Enhancing our understanding of the neural underpinnings of emotional cognitive control could be valuable for informing treatment for populations with deficits in these processes, such as adults with PTSD.

The current study utilizes a neuromodulatory approach called real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) whereby participants observe their own neural activity in the moment and are taught to self-regulate this activity. Adult volunteers, who have been diagnosed with PTSD, will be trained to increase neural activity in LDLPFC while involved in mental tasks involving emotional cognitive control processes. The mental tasks will include counting, remembering words, or planning events while viewing negatively-valenced emotional words (e.g., kill, death, threat). Participants in this study will complete a non-randomized LDLPFC rtfMRI-nf protocol to assess tolerability and feasibility of the protocol in a clinical population of interest. Resting-state fMRI scans and behavioral testing sessions will take place before and after rtfMRI-nf.

The specific aims are to examine the impact of LDLPFC rtfMRI-nf on: (1) LDLPFC activity during emotional cognitive control, (2) LDLPFC functional connectivity with other brain regions during rest, and (3) cognitive control task performance. As this study is meant to be preliminary, the target sample size is not powered to detect statistical significance for these measures. However, effect size estimates will be calculated to provide potential justification for future work with this protocol in this clinical population.

To these ends, this study will use rtfMRI-nf to examine preliminary evidence of a novel protocol to regulate LDLPFC activity in adults diagnosed with PTSD. This research will improve our understanding of emotional cognitive control and demonstrate whether this is a modifiable target for intervention in this clinical population of interest.

Study Overview

• Status: Withdrawn
• Conditions: PTSD; Cognitive Function
• Intervention / Treatment: Other: Real-time functional magnetic resonance neurofeedback (rtfMRI-nf)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Laureate Institute for Brain Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• able to provide informed consent
• sufficient English proficiency to complete procedures
• primary DSM-5 psychiatric diagnosis of posttraumatic stress disorder (PTSD)

Exclusion Criteria:

• significant or unstable physical or mental health conditions (e.g., immediate suicidal intent) requiring medical attention
• meeting criteria in either the present or past for the following DSM-5 psychiatric disorders: Schizophrenia Spectrum and Other Psychotic Disorders, Obsessive- Compulsive disorders, or Bipolar and Related Disorders
• recent change (i.e., within 6 weeks) for prescription of psychiatric medication
• current, regular benzodiazepine use
• history of moderate to severe traumatic brain injury
• diagnosis of neurologic disorders
• current alcohol/drug abuse
• MRI contra-indications (e.g., metal in body)
• uncorrected vision/hearing problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Left Dorsolateral Prefrontal Cortex rtfMRI-nf; Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) will target left dorsolateral prefrontal cortex. Participants in this arm will receive active feedback while attempting to modulate their neural activity during an emotional cognitive control task.	Other: Real-time functional magnetic resonance neurofeedback (rtfMRI-nf); Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) is a procedure using an MRI scanner that allows participants to observe their own neural activity in the moment. They are taught to self-regulate this activity during a task.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left dorsolateral prefrontal cortex activity during emotional cognitive control (pre- to post-neurofeedback)	Individual ability to regulate left dorsolateral prefrontal cortex activity during an emotional cognitive control task will be assessed before and after neurofeedback.	Approximately 2 hours after baseline assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left dorsolateral prefrontal cortex functional connectivity with other brain regions during rest (pre- to post-neurofeedback)	Individual functional connectivity values between left dorsolateral prefrontal cortex and other brain regions during rest will be assessed before and after neurofeedback.	Approximately 2 hours after baseline assessment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional Stroop Average Reaction Time	Average reaction time on the emotion condition of the emotional Stroop task.	Approximately 1 day after baseline assessment.
Color Word Stroop Average Reaction Time	Average reaction time on the inhibition condition of the color word Stroop task.	Approximately 1 day after baseline assessment.
Flanker Task Average Reaction Time	Average reaction time on the incongruent condition of the Flanker task.	Approximately 1 day after baseline assessment.
Emotional Stroop Reaction Time Difference	Difference in reaction time for emotional versus neutral conditions of the emotional Stroop task.	Approximately 1 day after baseline assessment.
Color Word Stroop Reaction Time Difference	Difference in reaction time for inhibition versus reading conditions of the emotional Stroop task.	Approximately 1 day after baseline assessment.
Flanker task Reaction Time Difference	Difference in reaction time for incongruent versus congruent conditions of the Flanker task.	Approximately 1 day after baseline assessment.

Collaborators and Investigators

• Sponsor: Laureate Institute for Brain Research, Inc.
• Investigators: Principal Investigator: Robin L Aupperle, Ph.D., Laureate Institute for Brain Research

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2019-012 - Part 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be released publicly, but requests for group-averaged results will be considered by individual request following publication of findings from this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No