Ventral Tegmental Area (VTA) Self-Activation in Attention Deficit Hyperactivity Disorder (ADHD)
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|ClinicalTrials.gov Identifier: NCT02723708|
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : May 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|ADHD||Other: Real-Time functional Magnetic Resonance Imaging Feedback (RTFF)||Not Applicable|
The study involves a screening visit and 4 experimental task sessions.During the screening visit subjects will undergo psychiatric screening to determine if they meet criteria for a diagnosis of ADHD. Participants who meet criteria for a diagnosis of ADHD will also have the following tests done at screening: breath alcohol test, urine drug screen and urine cotinine (by product of tobacco) screening and intelligence quotient (IQ) assessment. Eligible participants will complete a battery of cognitive assessments.
Participants meeting study inclusion will then be scheduled for 4 fMRI sessions to assess and manipulate the ability to self-stimulate VTA activation. Each session will contain the same tasks and instructions. The experimental imaging task sessions will be done within a one month window and will consist of two types of runs: Test Runs (one pre-test and post-test each) and three Training Runs.
The purpose of the Pre-Test is to establish a baseline level of self-generated VTA activation prior to receiving RTFF.
The Post-Test is designed to assess whether participants are better able to self-induce VTA BOLD signal in the absence of feedback (after receiving RTFF).
Participants will begin and end each scanning session with a 2-minute resting state scan. Participants will rest and fixate at a cross hair.
The purpose of the first run is to acquire data in functional space to facilitate registration of the VTA probabilistic atlas (MNI space) to functional space.
The Pre-Test and Post-Test runs will be identical and will have two trial types: Activate and Count.
During the Activate trials participants will be instructed to try to increase activity (BOLD signal) within their VTA. Specifically, we will instruct participants to try to get themselves into a heightened state of motivation using personally relevant thoughts and imagery. Importantly, they will be encouraged to optimize strategies for themselves.
During the Count trials, participants will be instructed to count backwards. The purpose of these trials is to: standardize the baseline period and to provide a distractor task to prevent engagement in activation strategies. There will be 5 repetitions of both trial types, separated by a jittered inter-trial-interval (ITI; total duration 4 minutes, 5 seconds).
The purpose of the subsequent training runs (n=3/day on each of the 4 days) is to provide participants with RTFF to assist them in increasing their VTA BOLD signal.
The training runs will consist of three trial types: Activate, Count, and Rest. For both Activate and Count Trials, participants will be given the same instructions as during the test runs. During the Rest trials participants will be instructed to rest and not think of anything in particular. The Activate and Rest trials will include a thermometer display, as described below. Each trial type will be repeated 5 times per run, separated by a jittered ITI (total duration 6 minutes, 18 seconds).
Following the Post-Test each day, the Cognitive Battery assessments will be repeated with the subject out of the scanner.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Increasing Motivation in Attention Deficit Hyperactivity Disorder (ADHD) Via Self-activation of Ventral Tegmental Area (VTA)|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||August 2021|
Experimental: Self activation of VTA bold signal
Participants meeting study inclusion will then be scheduled for 4 fMRI sessions to assess and manipulate the ability to self-stimulate VTA activation. Each session will contain the same tasks and instructions. The experimental imaging task sessions will be done 24-72 hours apart and will consist of two types of runs: Test Runs (one pre-test and post-test each) and three Training Runs. Participants will be instructed to achieve heightened state of motivation using personally relevant thoughts and imagery.
Other: Real-Time functional Magnetic Resonance Imaging Feedback (RTFF)
During the Activate trials, the thermometer will display the weighted average of VTA BOLD activation, dynamically updated every second. This continuously updated thermometer is the primary feedback mechanism.
- Percent signal change in VTA BOLD activation [ Time Frame: experiment session 1, approximately 1 hour ]The investigators will examine the % signal change in VTA BOLD activation during "Activate" versus "Count" trials during the Pre-Test run on experimental session 1, prior to RTFF training.
- Change in VTA BOLD signal following RTFF [ Time Frame: Baseline and following real time fMRI feedback, up to 4 weeks ]Four imaging task sessions will be done within a one month window
- Change in goal-directed behavior, as measured by the Effort discounting task [ Time Frame: Baseline and following each of the RTFF sessions, up to 2 weeks ]The amount of time before the participant terminates will assess their willingness to persist in goal-directed behavior. Four task sessions will be done 24-72 hours apart
- Change in inhibitory control, as measured by the Conners' Continuous Performance Task (CPT) [ Time Frame: Baseline and following each of the RTFF sessions, up to 2 weeks ]Four task sessions will be done 24-72 hours apart
- Change in attention, as measured by reaction time (RT) variability on the CPT [ Time Frame: Baseline and following each of the RTFF sessions, up to 2 weeks ]Four task sessions will be done 24-72 hours apart
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723708
|Contact: Nilda Itchon-Ramosfirstname.lastname@example.org|
|Contact: Scott Kollins, PhDemail@example.com|
|United States, North Carolina|
|Duke ADHD Program||Recruiting|
|Durham, North Carolina, United States, 27705|
|Contact: Nilda Itchon-Ramos 919-681-0032 firstname.lastname@example.org|
|Principal Investigator: Scott Kollins, PhD|
|Principal Investigator:||Scott Kollins, PhD||Duke University|
|Principal Investigator:||R. Alison Adcock, MD, PhD||Duke University|