N/A
N=30
Real-time fMRI and Neurofeedback of Brain Networks Mediating Trauma Memory Recall in PTSD
Stress Disorders, Post-Traumatic
Bottom Line
View on ClinicalTrials.gov: NCT02500719 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Patient Emotional Response to Volitional Engagement and Disengagement of Emotional Arousal as Measured Using Support Vector Machine Decodings When the Decoding is Provided as Real-time Neurofeedback Guidance or Not. — -.2104; .4659; -.2952; .0080 Standard score (decodings) — p=.029
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Computational Model - Real-time Support Vector Machine (Device)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- University of Arkansas
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Emotional Response to Volitional Engagement and Disengagement of Emotional Arousal as Measured Using Support Vector Machine Decodings When the Decoding is Provided as Real-time Neurofeedback Guidance or Not. |
-.2104; .4659; -.2952; .0080; -.0257; .5244 | .029 sig |
Summary
The purpose of the current study is to develop a better understanding of the brain mechanisms involved in psychological treatments for posttraumatic stress disorder (PTSD). This project will build on past research using script-driven imagery in our lab by investigating brain activity in areas activated during exposure to trauma-related cues. This project will also develop new knowledge concerning volitional control of those areas. The ultimate goal of this study is a better understanding of whether volitional control of these brain areas will improve therapeutic outcomes. This process will first be piloted in a sample of healthy controls. This will allow investigators to refine the methodology prior to recruiting a sample with PTSD.
Eligibility Criteria
Inclusion Criteria
- Female
- Aged 21-50
- Medically healthy
Exclusion Criteria
- Claustrophobia, or the inability to lie still in a confined space
- Major medical disorders (e.g., HIV, cancer)
- Magnetic metallic implants (such as screws, pins, shrapnel remnants, aneurysm clips, artificial heart valves, inner ear (cochlear) implants, artificial joints, and vascular stents)
- Electronic or magnetic implants, such as pacemakers
- Permanent makeup or tattoos with metallic dyes
- Currently pregnant
- A self-reported history of loss of consciousness (greater than 10 minutes)
- Physical disabilities that prohibit task performance (such as blindness or deafness)
- Psychotic disorders (e.g., schizophrenia)
- Any other condition that the investigator believes might put the participant at risk
Data sourced from ClinicalTrials.gov (NCT02500719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.