ADHDNCT02723708
Ventral Tegmental Area (VTA) Self-Activation in Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Real-Time functional Magnetic Resonance Imaging Feedback (RTFF) in people with ADHD, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- Real-Time functional Magnetic Resonance Imaging Feedback (RTFF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 5 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Motivation in Attention Deficit Hyperactivity Disorder (ADHD) Via Self-activation of Ventral Tegmental Area (VTA)
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).
Read the 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.
- Conditions
- ADHD
- Being tested
- Real-Time functional Magnetic Resonance Imaging Feedback (RTFF)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Self activation of VTA bold signal | Experimental | 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. Receives: Other: Real-Time functional Magnetic Resonance Imaging Feedback (RTFF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: experiment session 1, approximately 1 hour
Change in VTA BOLD signal following RTFF
Four imaging task sessions will be done within a one month window
Measured: Baseline and following real time fMRI feedback, up to 4 weeks
Secondary outcomes (3)
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
Measured: Baseline and following each of the RTFF sessions, up to 2 weeks
Change in inhibitory control, as measured by the Conners' Continuous Performance Task (CPT)
Four task sessions will be done 24-72 hours apart
Measured: Baseline and following each of the RTFF sessions, up to 2 weeks
Change in attention, as measured by reaction time (RT) variability on the CPT
Four task sessions will be done 24-72 hours apart
Measured: Baseline and following each of the RTFF sessions, up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startAug 2016
- Primary completion5 Oct 2021
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- R. Alison Adcock, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723708
- Sponsor's protocol ID
- Pro00070749
- Other IDs
- 1R01MH106751
- Status last verified
- Aug 2023
- First submitted
- 24 Mar 2016
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Motivation in Attention Deficit Hyperactivity Disorder (ADHD) Via Self-activation of Ventral Tegmental Area (VTA)
- ClinicalTrials.gov ID
- NCT02723708
- Acronym / sponsor ID
- Pro00070749
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2016
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self activation of VTA bold signal | Experimental | Other: Real-Time functional Magnetic Resonance Imaging Feedback (RTFF)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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Self activation of VTA bold signal |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Alison Adcock, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-Time functional Magnetic Resonance Imaging Feedback (RTFF) in people with ADHD, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent signal change in VTA BOLD activation (time frame: experiment session 1, approximately 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.