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临床试验/NCT04112082
NCT04112082Unknown不适用

Efficacy of Mobile Neurofeedback for Adult Attention-Deficit/Hyperactivity Disorder (ADHD)

Sheba Medical Center0 个研究点目标入组 70 人开始时间: 2019年12月22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
70
主要终点
Change in Continuous Performance Task (CPT) Response Time Variability

研究概览

简要总结

This study is an assessor-blind, parallel-group, controlled trial to evaluate the benefit of home-based training with a low-cost, mobile neurofeedback system (Myndlift) in adults with ADHD. Randomized controlled trials have shown significant benefit for neurofeedback, including persistent effects without the side effects of psychostimulants (i.e., diminished appetite, insomnia, anxiety, irritability). However, standard application requires clinic visits and significant expense, limiting training frequency and compromising potential efficacy. Additionally, extant evidence for efficacy comes almost exclusively from children and adolescents, with very few studies in adults. The present trial will measure the ability of home-based neurofeedback using a low-cost, user-friendly system to ameliorate symptomatology (e.g., enhancing attention, reducing impulsive behavior) in adults with ADHD. Participants will receive either neurofeedback or treatment as usual (TAU). Primary outcomes will be objective scores on a continuous performance task (CPT) and subjective report on a standardized adult ADHD symptoms questionnaire. Eligible participants recruited from an adult ADHD clinic will complete a baseline assessment (1.25 hours) including subjective questionnaires, computerized cognitive assessment, and resting-state EEG administered by a blinded assessor. The experimental group will train at home with a neurofeedback headset and tablet 4 times/week for ten weeks (session duration: 21-30 minutes). Neurofeedback will be provided via a conventional theta beta protocol in which participants train using gamified tasks, videos, or audio clips in a tablet-based app, and receive positive visual/auditory feedback when their brainwaves are in the desired range. The control group will follow the regular treatment plan set by the clinic (i.e., treatment as usual; TAU). Care may include pharmacological intervention, cognitive behavioral therapy (CBT), a combination of both, or no intervention. Care will often include pharmacological intervention (e.g., methylphenidate), with the specifics (e.g., type of medication, dosage) determined by psychiatrist recommendation. After completing the ten-week intervention period, all participants will return to the clinic for a follow-up assessment identical to the baseline assessment. It is hypothesized that home-based neurofeedback training will demonstrate non-inferiority to TAU as measured by improvement in subjective and objective symptoms.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (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

入选标准

  • willingness to provide consent
  • diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) of any type as ascertained by clinical interview conducted by a board-certified psychiatrist
  • at the time of enrollment, not receiving treatment for symptoms of ADHD

排除标准

  • comorbid psychotic or bipolar disorder or an active affective disorder
  • medical disorder with potentially confounding psychiatric effects (either due to direct effects of the condition or medication effects)
  • diagnosis of substance abuse disorder (SUD), sleep apnea, restless legs syndrome (RLS), or borderline intellectual functioning
  • unable to attend in-clinic follow-up assessment
  • antipsychotic agent in the three months prior to baseline assessment
  • any selective serotonin reuptake inhibitor (SSRI) treatment in the four weeks prior to baseline
  • other psychiatric medication in the two weeks prior to baseline that the principal investigator deems to be confounding
  • experimental group only: plans to start stimulant medication during the course of the study (use of nutritional supplements including "prescription medical foods" is not exclusionary)
  • neurofeedback treatment in the two years prior to baseline

研究组 & 干预措施

Home-Based Neurofeedback Training

Experimental

干预措施: Mobile Neurofeedback (Behavioral)

Treatment as Usual

Active Comparator

干预措施: Treatment as Usual (Other)

结局指标

主要结局

Change in Continuous Performance Task (CPT) Response Time Variability

时间窗: baseline, immediately after 10-week intervention period

standard deviation of response time for correct responses on a computerized CPT

Change in Continuous Performance Task (CPT) Response Time

时间窗: baseline, immediately after 10-week intervention period

mean response time for correct responses on a computerized CPT

Change in Self-Reported ADHD Symptoms

时间窗: baseline, immediately after 10-week intervention period

total score on the Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1)

次要结局

  • Continuous Performance Task (CPT) Omission Errors(baseline, immediately after 10-week intervention period)
  • EEG Theta/Beta Ratio(baseline, immediately after 10-week intervention period)
  • Continuous Performance Task (CPT) Commission Errors(baseline, immediately after 10-week intervention period)
  • Continuous Performance Task (CPT) Accuracy(baseline, immediately after 10-week intervention period)
  • Executive Function Domain Score from Cognitive Battery(baseline, immediately after 10-week intervention period)
  • ADHD Screener Score(baseline, immediately after 10-week intervention period)
  • ADHD Symptom Inattention Subtype Score(baseline, immediately after 10-week intervention period)
  • Global Cognitive Score from Cognitive Battery(baseline, immediately after 10-week intervention period)
  • Information Processing Speed Domain Score from Cognitive Battery(baseline, immediately after 10-week intervention period)
  • EEG Theta Amplitude(baseline, immediately after 10-week intervention period)
  • EEG Beta Amplitude(baseline, immediately after 10-week intervention period)
  • Attention Domain Score from Cognitive Battery(baseline, immediately after 10-week intervention period)
  • ADHD Symptom Hyperactivity/Impulsivity Subtype Score(baseline, immediately after 10-week intervention period)

研究者

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

Dr. Tamir Epstein

Head of Unit for Adult Developmental Disorders

Sheba Medical Center

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