Increasing Motivation in Attention Deficit Hyperactivity Disorder (ADHD) Via Self-activation of Ventral Tegmental Area (VTA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Percent signal change in VTA BOLD activation
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Percent signal change in VTA BOLD activation
时间窗: 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
时间窗: Baseline and following real time fMRI feedback, up to 4 weeks
Four imaging task sessions will be done within a one month window
次要结局
- 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)