Performance and fMRI BOLD Signal Changes in Impulsive Patients
NCT Number: NCT06491160
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Attention Deficit Hyperactivity Disorder|Borderline Personality Disorder
Sponsor: Simone Grimm
Collaborators: Charité Research Organisation GmbH|Boehringer Ingelheim
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2024-10
Locations: Charité Research Organisation GmbH, Berlin, Germany

Summary:
This study is a preceding study conducted to validate the methodology for assessing impulsivity by tasks and task-based fMRI measurements in patients with Attention Deficit Hyperactivity Disorder (ADHD) or Borderline Personality Disorder (BPD).

Primary Outcome Measures: Average percent BOLD signal change during the 4-Choice Serial-Reaction Time Task (4-CSRTT), Blood oxygen level dependent (BOLD) fMRI signal changes will be analyzed to identify brain regions with significant activation during the 4-CSRTT, During the 4-CSRTT on experimental day (visit number 2 (study day 1))|Average percent BOLD signal change during the Stop Signal Task (SST), Blood oxygen level dependent (BOLD) fMRI signal changes will be analyzed to identify brain regions with significant activation during the SST, During the SST on experimental day (visit number 2 (study day 1))|Average percent BOLD signal change during resting state, Blood oxygen level dependent (BOLD) fMRI signal magnitude and BOLD signal standard deviation during resting state, During resting state on experimental day (visit number 2 (study day 1))|Assessment of brain perfusion, Change in relative and absolute cerebral blood flow are measured through Arterial Spin Labeling (ASL), During asl on experimental day (visit number 2 (study day 1))
Other Outcome Measures: Correlation between BOLD signal during the 4-CSRTT and impulsivity scores on the BIS-11, Correlation between magnitude of BOLD signal during the 4-CSRTT and impulsivity scores on the BIS-11, Impulsivity scores were assessed on the screening day (visit number 1 (study days -28 to -1)), while BOLD signal changes during the 4-CSRTT were measured on the experimental day (visit number 2 (study day 1))|Correlation between BOLD signal during the SST and impulsivity scores on the BIS-11, Correlation between magnitude of BOLD signal during the SST and impulsivity scores on the BIS-11, Impulsivity scores were assessed on the screening day (visit number 1 (study days -28 to -1)), while BOLD signal changes during the SST were measured on the experimental day (visit number 2 (study day 1))|Correlation between BOLD signal during the 4-CSRTT and impulsivity scores on the S-UPPS, Correlation between magnitude of BOLD signal during the 4-CSRTT and impulsivity scores on the S-UPPS, Impulsivity scores were assessed on the screening day (visit number 1 (study days -28 to -1)), while BOLD signal changes during the 4-CSRTT were measured on the experimental day (visit number 2 (study day 1))|Correlation between BOLD signal during the SST and impulsivity scores on the S-UPPS, Correlation between magnitude of BOLD signal during the SST and impulsivity scores on the S-UPPS, Impulsivity scores were assessed on the screening day (visit number 1 (study days -28 to -1)), while BOLD signal changes during the SST were measured on the experimental day (visit number 2 (study day 1))|Reaction times in ms, Reaction times in ms extracted from the in- scanner protocol log files, During all tasks on experimental day (visit number 2 (study day 1))|Premature responses, Number of premature responses extracted from the in- scanner protocol log files, During all tasks on experimental day (visit number 2 (study day 1))|Reaction times during the 4-CSRTT after stress induction, Task performance is measured based on the reaction times (RTs) for choices. Stress is induced using the Mannheim Multicomponent Stress Test (MMST)., During the 4-CSRTT after stress is induced on experimental day (visit number 2 (study day 1))|Premature responses during the 4-CSRTT after stress induction, Task performance is measured based on the number of premature responses. Stress is induced using the Mannheim Multicomponent Stress Test (MMST)., During the 4-CSRTT after stress is induced on experimental day (visit number 2 (study day 1))|Impulsive choice ratio during the 4-CSRTT after stress induction, Task performance is measured based on the impulsive choice ratio. Stress is induced using the Mannheim Multicomponent Stress Test (MMST)., During the 4-CSRTT after stress is induced on experimental day (visit number 2 (study day 1))|Reaction times during the DDT after stress induction, Task performance is measured based on reaction times (RTs) for choices. Stress is induced using the Mannheim Multicomponent Stress Test (MMST)., During the DDT after stress is induced on experimental day (visit number 2 (study day 1))|Premature responses during the DDT after stress induction, Task performance is measured based on the number of premature responses. Stress is induced using the Mannheim Multicomponent Stress Test (MMST)., During the DDT after stress is induced on experimental day (visit number 2 (study day 1))|Correlation between BOLD signal and behavioral measures during 4-CSRTT, Correlation between magnitude of BOLD signal during 4-CSRTT and behavioral measures of the 4-CSRTT, during the 4-CSRTT conducted in the scanner on experimental day (visit number 2 (study day 1))|Correlation between BOLD signal and behavioral measures during SST, Correlation between magnitude of BOLD signal during SST and behavioral measures of the SST, during the SST conducted in the scanner on experimental day (visit number 2 (study day 1))