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临床试验/NCT04408521
NCT04408521Unknown不适用

Effect of Long-lasting EEG-Neurofeedback on Attention Control and Impulsivity in Adult Attention-Deficit/Hyperactivity Disorder (ADHD)

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
5
试验地点
1
主要终点
Change in assessor-evaluated clinical ADHD status

研究概览

简要总结

Mounting evidence suggests that closed-loop brain-training, commonly known as neurofeedback (NFB), may represent a new therapeutic opportunity for patients with Attentional Deficit/Hyperactivity Disorder (ADHD), which manifests as difficulties with attention and inhibitory control. In this context, the investigators have focused on an attention-enhancing form of NFB based on the EEG alpha rhythm, known to influence sensory detection and attention. In light of recent evidence showing that both attention and impulsivity can be modified with a single-session of alpha-NFB, the objective is to determine whether these effects stabilize in the long-term, after multiple, daily sessions of training at home.

A short- (single-session) and a long-term (multi-session) experimental design will be used to collect EEG, behavioral, and clinical data pre-to-post NFB. The single-blind study will recruit 48 adult ADHD participants randomly assigned to either NEUROFEEDBACK or CONTROL groups. Each participant will undergo individual at home sessions of 45-minute video-replay of popular television (TV) series while recording their 1-channel EEG (30 sessions, 5 sessions/week, 6 weeks total). In the NEUROFEEDBACK group, self-regulation of alpha rhythm will be reflected in the dynamically varying opacity of the video-replay window, i.e. the window would turn lighter/darker and reveal/obscure video content during episodes of low/high alpha amplitude, respectively. In the CONTROL group, the recording will be passive without real-time EEG neurofeedback (i.e. constant brightness and volume). Before and after at home training, each participant will have two visits in the lab: (1) complete clinical and neuropsychological evaluation and (2) EEG session including resting state and task-related EEG before and after a short NFB intervention (30 minutes). For the CONTROL group participants, the latter will be replaced by a sham intervention utilizing non-contingent feedback.

Given that stronger alpha rhythmicity is associated with increases in inhibitory/excitatory balance, it is expected that alpha-NFB (i) will homeostatically normalize alpha rhythm power and (ii) the degree of normalization will be a dimensional predictor of individual improvement in behavioral and clinical measures of executive function, impulsivity and inattention. These results should lay the foundation for building neurocognitive treatments, by harnessing neuroplasticity mechanisms intrinsic to the brain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, 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
否

入选标准

  • •Clinical diagnosis of ADHD
  • •Currently stabilized (euthymic)
  • •General good health
  • •Normal or corrected-to normal visual acuity

排除标准

  • •Mood Disorders
  • •Borderline Personality Disorder
  • •Substance Use Disorder
  • •Structural Brain Abnormalities
  • •Cerebrovascular Disease
  • •Head Trauma
  • •Cardiovascular Disease
  • •Renal Failure
  • •Hepatic Dysfunction
  • •Impaired visual acuity

研究组 & 干预措施

NEUROFEEDBACK

Experimental

Participants undergo individual at home sessions of 45-minute video-replay of popular TV series while recording their 1-channel EEG using a portable system. Self-regulation of alpha rhythm is reflected in the dynamically varying opacity of the video replay window, i.e. the window would turn lighter/darker and reveal/obscure video content during episodes of low/high alpha amplitude, respectively.

干预措施: NEUROFEEDBACK (Other)

CONTROL

Placebo Comparator

Participants undergo individual at home sessions of 45-minute video-replay of popular TV series while recording their 1-channel EEG using a portable system. The recording is passive without real-time EEG neurofeedback (i.e. constant brightness and volume).

干预措施: CONTROL (Other)

结局指标

主要结局

Change in assessor-evaluated clinical ADHD status

时间窗: Change between day 10 pre-intervention and day 10 post-intervention

Change in adult ADHD Child Evaluation (ACE+) scoring (min = 0, max = 36, higher score = worse outcome)

Change in self-reported clinical ADHD status

时间窗: Change between day 10 pre-intervention and day 10 post-intervention

Change in adult ADHD Self-Report Scale (ASRS) scoring (min = 0, max = 72, higher score = worse outcome)

Change in Alpha Spectral Power

时间窗: Change between day 2 pre-intervention and day 2 post-intervention

Absolute and relative spectral alpha power in the 8-12 Hz frequency range at rest (microvolts)

Change in reaction time at the Continuous Performance Task (CPT)

时间窗: Change between day 2 pre-intervention and day 2 post-intervention

Reaction time and reaction time variability (milliseconds)

Change in error rates at the CPT

时间窗: Change between day 2 pre-intervention and day 2 post-intervention

Number of omission and commission errors

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nader Perroud

MD, Associate Professor

University Hospital, Geneva

研究点 (1)

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