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

NCT02723708 | Completed

• 2 other identifiers: Pro000707491R01MH106751
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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).

Conditions

ADHD

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

  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)

  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

  Baseline and following each of the RTFF sessions, up to 2 weeks

Study Arms (1)

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.

Other: Real-Time functional Magnetic Resonance Imaging Feedback (RTFF)

Interventions

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.

Self activation of VTA bold signal

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Duke ADHD Program

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• R. Alison Adcock, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: March 30, 2016
• Study Start: August 1, 2016
• Primary Completion: October 5, 2021
• Study Completion: October 5, 2021
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)