Ventral Tegmental Area (VTA) Self-Activation in Attention Deficit Hyperactivity Disorder (ADHD)
Primary Purpose
ADHD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Real-Time functional Magnetic Resonance Imaging Feedback (RTFF)
Sponsored by
About this trial
This is an interventional other trial for ADHD
Eligibility 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
Sites / Locations
- Duke ADHD Program
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Self activation of VTA bold signal
Arm Description
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.
Outcomes
Primary Outcome Measures
Percent signal change in VTA BOLD activation
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
Four imaging task sessions will be done within a one month window
Secondary Outcome Measures
Change in goal-directed behavior, as measured by the Effort discounting task
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)
Four task sessions will be done 24-72 hours apart
Change in attention, as measured by reaction time (RT) variability on the CPT
Four task sessions will be done 24-72 hours apart
Full Information
NCT ID
NCT02723708
First Posted
March 24, 2016
Last Updated
August 17, 2023
Sponsor
Duke University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT02723708
Brief Title
Ventral Tegmental Area (VTA) Self-Activation in Attention Deficit Hyperactivity Disorder (ADHD)
Official Title
Increasing Motivation in Attention Deficit Hyperactivity Disorder (ADHD) Via Self-activation of Ventral Tegmental Area (VTA)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
October 5, 2021 (Actual)
Study Completion Date
October 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self activation of VTA bold signal
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Real-Time functional Magnetic Resonance Imaging Feedback (RTFF)
Intervention Description
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 Measure Information:
Title
Percent signal change in VTA BOLD activation
Description
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.
Time Frame
experiment session 1, approximately 1 hour
Title
Change in VTA BOLD signal following RTFF
Description
Four imaging task sessions will be done within a one month window
Time Frame
Baseline and following real time fMRI feedback, up to 4 weeks
Secondary Outcome Measure Information:
Title
Change in goal-directed behavior, as measured by the Effort discounting task
Description
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
Time Frame
Baseline and following each of the RTFF sessions, up to 2 weeks
Title
Change in inhibitory control, as measured by the Conners' Continuous Performance Task (CPT)
Description
Four task sessions will be done 24-72 hours apart
Time Frame
Baseline and following each of the RTFF sessions, up to 2 weeks
Title
Change in attention, as measured by reaction time (RT) variability on the CPT
Description
Four task sessions will be done 24-72 hours apart
Time Frame
Baseline and following each of the RTFF sessions, up to 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Alison Adcock, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke ADHD Program
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Ventral Tegmental Area (VTA) Self-Activation in Attention Deficit Hyperactivity Disorder (ADHD)
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