Determining the Most Effective Training Region in ADHD Neurofeedback (NF) Therapy - Functional Near-infrared Spectroscopy NF of the Dorsolateral Prefrontal Cortex (DLPFC) vs. Inferior Frontal Gyrus (IFG) in Healthy Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change of n-back reaction times after neurofeedback training compared to baseline
研究概览
简要总结
The aim of the following study is to investigate which is the best region of interest (ROI) for a functional near-infrared spectroscopy (fNIRS)-based neurofeedback (NF) training for highly-impulsive individuals (and consequently also patients with attention-deficit/hyperactivity disorder, ADHD): the dorsolateral prefrontal cortex (DLPFC) or the inferior frontal gyrus (IFG). Generally, NF trainings aim to improve the neurophysiological as well as cognitive-behavioral deficits observed in many neuropsychiatric disorders and were shown to constitute an effective complementary treatment option for patients with ADHD. Some previous studies used the DLPFC as a ROI for NF training, while others focused on the IFG as the main target region. However, so far, no study has directly compared the effectiveness of NF trainings targeting the DLPFC vs. IFG using the same protocol or the specificity of regulation efforts between these two areas using fNIRS. Therefore, the aim of the current study is to compare the effectiveness of fNIRS-NF using the DLPFC as a ROI with fNIRS-NF using the IFG as a ROI in a randomized controlled study design with highly-impulsive, healthy participants.
Furthermore, the investigators aim to test the effect of fNIRS-NF training in the context of stress. Previous studies reported that there is a strong connection between ADHD and stress. However, the effect of fNIRS-NF training for the adaptation to stressful situations is uncertain.
To this end, the investigators will assess the brain activity of participants before and after an fNIRS-NF training period during performance of a Go/NoGo task, an n-back task and The Trier Social Stress Test (TSST). It is hypothesized that both trainings will be successful in reducing impulsive behavior; however, in the pre/post testing, specific effects of fNIRS-based NF of the DLPFC are expected on working memory function and of fNIRS-based NF of the IFG on inhibitory control (Go/NoGo task). Correlations between both functions and impulsive symptoms will give an indication which training ROI may be more promising for the treatment of (specific subgroups of) ADHD. Correlations between regulation of different training ROIs will indicate the specificity of feedback regulation of circumscribed cortical areas.
详细描述
Aims:
The investigators will assess the effects - and specificity - of two fNIRS-based NF protocols, one targeting the DLPFC and one targeting the IFG. Both groups will also be compared to a "sham" training group with regulation of the fNIRS signal outside of the frontal lobes. Pre/post testing will be conducted in all three groups, i.e., measures of brain activity, cognition and impulsive behavior will be obtained before the start of the NF training phase as well as following the last training session. Thereby, a Go/Nogo task and an n-back task will be applied to evaluate training-related changes in brain activity and neuropsychological performance. The study population will be highly impulsive (healthy) individuals, who were previously found to show a reduced DLPFC and IFG activity (similar to patients with ADHD), and the investigators expect their DLPFC and IFG function to increase after fNIRS-NF training. Our hypothesis is that both active NF groups (DLPFC and IFG) will improve more than the placebo (sham training) group on all relevant measures. Thereby, specific advantages are expected in the DLPFC group for working memory data (n-back task) and in the IFG group for measures of inhibitory control (Go/Nogo task). Further, the investigators will test the effect of fNIRS-NF on the stress response using the TSST as a standardized stress test. It is hypothesized that fNIRS-NF training is also effective in reducing stress by strengthening stress-related regulation (that has also been related to the frontal lobe).
It is hypothesized that both trainings will be successful in reducing impulsive behavior; however, in a pre/post testing, specific effects of fNIRS-based NF of the DLPFC on working memory function and of fNIRS-based NF of the IFG on inhibitory control is expected. Correlations between both functions and impulsive symptoms will give an indication which training ROI may be more promising for the treatment of (specific subgroups of) ADHD. Correlations between regulation of different training ROIs will indicate the specificity of feedback regulation of circumscribed cortical areas.
Functional near-infrared spectroscopy (fNIRS):
An fNIRS system (ETG-4000, Hitachi Medical Corporation, Japan) will be used to measure hemodynamic responses within the prefrontal cortex (PFC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed written consent
- •ASRS score in subscale (Items 10 bis 18) "hyperactivity/impulsivity" >=17
- •No additional serious physical, neurological or mental disorder.
排除标准
- •ASRS score "hyperactivity/impulsivity"<17
- •Self-reported diagnosis of one or more of the following
- •Serious physical or chronic illness such as lung disease, heart disease, diabetes (E10-E14 according to ICD-10), hypertension (I10.x according to ICD-10), and rheumatic diseases
- •Neurological disorders including stroke, multiple sclerosis and epilepsy
- •History of moderate or severe craniocerebral injury (GCS 3-12) / second or third degree craniocerebral injury with period of unconsciousness exceeding 30 minutes
- •Indicated psychiatric disorders including bipolar disorder, psychosis, obsessive-compulsive disorder, chronic tics, Tourette syndrome, and suicidal behavior; in addition to self-report, these will be screened for by using the SCID (Structured Clinical Interview for DSM-IV) screening questions
- •Prior participation in a NF training.
- •Other psychotherapeutic treatment or any kind of attention training, also in the course of an ergotherapeutic treatment, while participating in the study
结局指标
主要结局
Change of n-back reaction times after neurofeedback training compared to baseline
时间窗: Change from baseline to immediately after the 8th neurofeedback training session
Reaction times (mean and standard deviation) obtained during a block-design n-back (working memory) task (0-back, 1-back, and 3-back condition)
Change of n-back error rates after neurofeedback training compared to baseline
时间窗: Change from baseline to immediately after the 8th neurofeedback training session
Error rates (hits, misses, false alarms) obtained during a block-design n-back (working memory) task (0-back, 1-back, and 3-back condition)
Change of Go/NoGo error rates after neurofeedback training compared to baseline
时间窗: Change from baseline to immediately after the 8th neurofeedback training session
Error rates (hits, misses, false alarms) obtained during a Go/NoGo task (Go and NoGo blocks)
Change of Go/NoGo reaction times after neurofeedback training compared to baseline
时间窗: Change from baseline to immediately after the 8th neurofeedback training session
Reaction times (mean and standard deviation) obtained during a Go/NoGo task (Go and NoGo blocks)
Change of Go/NoGo brain activation data (fNIRS) after neurofeedback training compared to baseline
时间窗: Change from baseline to immediately after the 8th neurofeedback training session
Oxygenation changes (fNIRS data) during the Go and NoGo condition of the go-nogo task in pre-defined regions of interest (DLPFC \[BA9 and 46\], IFG, temporal cortex)
Neurofeedback learning success based on the online feedback signal (number of correct trials)
时间窗: Change from neurofeedback session 1 to session 8
Increase in the number of successful neurofeedback training trials from session 1 to session 8 (for feedback and transfer trials, up- and down-regulation)
Neurofeedback learning success based on an offline analysis of successful up- vs. down-regulation
时间窗: Change from neurofeedback session 1 to session 8
Increase in the differentiation between up- and down-regulation of the fNIRS signal from session 1 to session 8 (for feedback, transfer and all trials; offline analysis)
Change of N-back brain activation data (fNIRS) after neurofeedback training compared to baseline
时间窗: Change from baseline to immediately after the 8th neurofeedback training session
Oxygenation changes (fNIRS data) during the 3-back, 1-back, and 0-back condition of the n-back task in pre-defined regions of interest (DLPFC \[Brodman area/BA9 and 46\], IFG, temporal cortex)
Neurofeedback learning success based on the online feedback signal (percentage of correct time-points)
时间窗: Change from neurofeedback session 1 to session 8
Increase in the percentage of time-points (in the second half of all neurofeedback regulation trials) where the fNIRS feedback signal was regulated in the correct direction from session 1 to session 8 (for feedback and transfer trials, up- and down-regulation)
次要结局
- Correlation of internal-external control beliefs with neurofeedback learning outcome(Baseline/pre-intervention)
- Correlation of general self-efficacy with neurofeedback learning outcome(Baseline/pre-intervention)
- Correlation of trait impulsivity with neurofeedback learning outcome(Baseline/pre-intervention)
- Correlation of trait anxiety with neurofeedback learning outcome(Baseline/pre-intervention)