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

PTSD Clinical Trial

— SPrC-PTSD  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04543513
• Other study ID #: 2019-012 - Part 2
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: Laureate Institute for Brain Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Function
• PTSD

Intervention

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.

Locations

Country	Name	City	State
United States	Laureate Institute for Brain Research	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Laureate Institute for Brain Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Emotional Stroop Average Reaction Time	Average reaction time on the emotion condition of the emotional Stroop task.	Approximately 1 day after baseline assessment.
Other	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.
Other	Flanker Task Average Reaction Time	Average reaction time on the incongruent condition of the Flanker task.	Approximately 1 day after baseline assessment.
Other	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.
Other	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.
Other	Flanker task Reaction Time Difference	Difference in reaction time for incongruent versus congruent conditions of the Flanker task.	Approximately 1 day after baseline assessment.
Primary	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	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