fMRI in Impulsivity

Study Overview
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Brief Summary
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This study aims to use resting-state and task based functional Magnetic Resonance Imaging (fMRI) as a tool to evaluate trait characteristics of impulsivity in subjects with borderline personality disorder.

Official Title
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Assessment of Longitudinal Functional Magnetic Resonance Imaging (fMRI) as a Brain Measure for Impulsivity in a Borderline Personality Disorder (BPD) Model

Conditions
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Impulse Control Disorders, Borderline Personality Disorder

Intervention / Treatment
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* Behavioral: Experimental


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy Controls: Volunteers (age 18-50 yrs) in generally good Psychiatric and non-Psychiatric medical health Borderline Personality Disorder subjects: Research volunteers (age 18-50 yrs) who meet DSM-5 criteria for Borderline Personality Disorder Exclusion criteria: All Participants: Current medications which affect the central nervous system or vascular activity, such as anti-depressants, anxiolytics, or blood-pressure medications Positive urine drug screen for cocaine, opioids, amphetamine, and benzodiazepines Positive breathalyzer test for alcohol History of clinically significant neurologic disorders or head trauma with loss of consciousness greater than 30 minutes Clinically significant non-psychiatric medical disorder requiring ongoing treatment. Unwillingness or inability to sign a written informed consent form Pregnancy as assessed by a urine test for ß-HCG at each visit Medical or physical contraindications for participation based on medical history interview, labs, and physical exam Metal fragments or other bodily metal (e.g., pacemaker, orthopedic prosthesis),claustrophobia, or any other condition that would put the subjects at risk for MRI scanning In addition, Healthy Controls excluded, if: DSM-5 diagnoses of Personality Disorders (based on SCID-II) DSM-5 diagnoses based on the SCID-I (including the eating disorders module) History of arrest or incarceration In addition, Borderline Personality Disorder Subjects excluded if: DSM-5 diagnoses DSM-5 Personality Disorder other than Cluster B Personality disorders Current psychoactive medications Further exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BPD<br>Borderline Personality Disorder as diagnosed by DSM-5 | Behavioral: Experimental<br>* with functional imaging and behavioural measurements at baseline and 4 weeks<br>|
| normal volunteers<br>normal volunteers | Behavioral: Experimental<br>* with functional imaging and behavioural measurements at baseline and 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Affective Faces Task (AFT) fMRI response |  | up to 5 weeks | 
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Monetary Incentive Delay (MID) fMRI task response |  | up to 5 weeks | 
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for resting-state functional magnetic resonance imaging (fMRI) activity |  | up to 5 weeks | 
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Go/ No Go functional magnetic resonance imaging (fMRI) response |  | up to 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 4 week follow-up visit for Eye Tracking |  | up to 5 weeks | 
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Immediate Memory Task (IMT) behavioral test |  | up to 5 weeks | 
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Computerized monetary choice procedure behavioral test |  | up to 5 weeks | 
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Stop-signal paradigm behavioral test |  | up to 5 weeks | 
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Barratt Impulsiveness Scale v.11 (BIS-11) |  | up to 5 weeks | 
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Profile of Mood States behavioral test |  | up to 5 weeks | 
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Go/ No Go task behavioral test |  | up to 5 weeks | 
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Urgency, Premeditation, Perseverance, Sensation Seeking, and Positive Urgency (UPPS-P) Impulsive behavior Scale, subscale for premeditation |  | up to 5 weeks | 
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Urgency, Premeditation, Perseverance, Sensation Seeking, and Positive Urgency (UPPS-P) Impulsive behavior Scale, subscale for perseverance |  | up to 5 weeks | 
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Urgency, Premeditation, Perseverance, Sensation Seeking, and Positive Urgency (UPPS-P) Impulsive behavior Scale, subscale for sensation seeking |  | up to 5 weeks | 
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Urgency, Premeditation, Perseverance, Sensation Seeking, and Positive Urgency (UPPS-P) Impulsive behavior Scale, subscale for urgency |  | up to 5 weeks |