Clinical trial NCT04543513: Self-regulation of Prefrontal Cortex During Emotional Cognitive Control in PTSD
Official title: Self-regulation of Prefrontal Cortex During Emotional Cognitive Control in PTSD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: PTSD
Cognitive Function
Lead sponsor: Laureate Institute for Brain Research, Inc.
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Left dorsolateral prefrontal cortex activity during emotional cognitive control (pre- to post-neurofeedback)
timeFrame: Approximately 2 hours after baseline assessment
Secondary outcomes:
measure: Left dorsolateral prefrontal cortex functional connectivity with other brain regions during rest (pre- to post-neurofeedback)
timeFrame: Approximately 2 hours after baseline assessment
Other outcomes:
measure: Emotional Stroop Average Reaction Time
timeFrame: Approximately 1 day after baseline assessment.
measure: Color Word Stroop Average Reaction Time
timeFrame: Approximately 1 day after baseline assessment.
measure: Flanker Task Average Reaction Time
timeFrame: Approximately 1 day after baseline assessment.
measure: Emotional Stroop Reaction Time Difference
timeFrame: Approximately 1 day after baseline assessment.
measure: Color Word Stroop Reaction Time Difference
timeFrame: Approximately 1 day after baseline assessment.
measure: Flanker task Reaction Time Difference
timeFrame: Approximately 1 day after baseline assessment.
Locations:
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
Study officials:
affiliation: Laureate Institute for Brain Research
name: Robin L Aupperle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: