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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 : March 14, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Duke University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
ADHD Other: Real-Time functional Magnetic Resonance Imaging Feedback (RTFF) Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Nilda Itchon-Ramos 919-681-0032 nilda.itchonramos@dm.duke.edu
Contact: Scott Kollins, PhD 919-681-0014 scott.kollins@dm.duke.edu

Locations
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United States, North Carolina
Duke ADHD Program Recruiting
Durham, North Carolina, United States, 27705
Contact: Nilda Itchon-Ramos    919-681-0032    nilda.itchonramos@dm.duke.edu   
Principal Investigator: Scott Kollins, PhD         
Sponsors and Collaborators
Duke University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Scott Kollins, PhD Duke University
Principal Investigator: R. Alison Adcock, MD, PhD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02723708     History of Changes
Other Study ID Numbers: Pro00070749
1R01MH106751 ( Other Identifier: NIMH )
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders