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Completed

NCT Number: NCT02723708

Ventral Tegmental Area (VTA) Self-Activation in Attention Deficit Hyperactivity Disorder (ADHD)

The purpose of this study is to see if a non-medication intervention can increase motivation in individuals with ADHD by observing brain activity using magnetic resonance imaging (MRI).

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke ADHD Program

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-45 years of age
  • Male or Female
  • Confirmed diagnosis, any subtype as determined by the clinician administered Conner's Adult ADHD Diagnostic Interview for DSM-IV (CAADID) and clinical interview using the Mini International Neuropsychiatric Interview (MINI)
  • T-Score > 65 on one of the DSM-IV relevant scales (Inattentive Symptoms, Hyperactive-Impulsive Symptoms, Total Symptoms or ADHD Index) on both the Self-Report and Observer versions of the Conner's Adult ADHD Rating Scales (CAARS)
  • Cognitive functioning eaqual or greater than 80 as assessed by the Kaufman Brief Intelligence test, Second Edition (KBIT-II)

Exclusion criteria

  • History of chronic/significant medical condition
  • Current or past 6 month use of prescription medications for ADHD or other psychiatric condition
  • Meets criteria for any other Axis I Disorder (determined the Mini International Neuropsychiatric Interview (MINI) other than nicotine dependence that is significantly impairing and would contraindicate participation in the present study
  • Meets criteria for any Axis II Disorder
  • Current substance abuse or dependence or history within the last 12 months; expired breath alcohol level > 0.0; Positive urine drug screen for any of the following: cannabis, amphetamines, opioids, benzodiazepines, barbiturates, cocaine
  • Inability to understand written and/or spoken English language
  • Claustrophobia or other contraindications to MRI scanning
  • If female, pregnancy as determined by urine pregnancy test on each day of MRI scanning
  • Presence of any metal in the body (e.g., implant, non-removable piercing, IUD)
  • Head injury resulting in loss of consciousness
  • Worked with metal (e.g., welding) or had an injury to the eye involving metal
  • Weigh more than 250 pounds

Treatment and study plan

Real-Time functional Magnetic Resonance Imaging Feedback (RTFF)

Other

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Increasing Motivation in Attention Deficit Hyperactivity Disorder (ADHD) Via Self-activation of Ventral Tegmental Area (VTA)

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Mar 30, 2016
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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