Targeted Neurofeedback Training to Alleviate Tinnitus Distress
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 主要终点
- Score on the Tinnitus Functional Index
研究概览
简要总结
The broad goals of this project are to apply and validate the therapeutic utility of neurofeedback-guided intervention for tinnitus and its associated psychological sufferings. In this project, the investigators will evaluate whether targeted (non-auditory networks) neurofeedback-based training can restore emotional and cognitive health for individuals with bothersome tinnitus. The investigators will also link individual tinnitus scores with objective brain imaging measures before, during, and after the intervention. The investigators will accomplish these goals by using a combined brain imaging and behavioral experimental framework.
详细描述
Intervention via neurofeedback has shown promising results for many neurological disorders including schizophrenia, post-traumatic stress disorder, ADHD, anxiety and major depressive disorder, with benefits lasting over several weeks after the completion of training ; neurofeedback-guided training has led to participants successfully alter activity in brain regions that mediate emotional response, mood and cognitive control. Because these brain regions and functions are also implicated in bothersome tinnitus, real-time neurofeedback training based on ongoing activity in these targets can potentially improve the psychological distress associated with tinnitus severity. Real-time neurofeedback can provide a valuable training tool for coping with tinnitus-related distress and help underpin the development of intervention-based treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participant will not be made aware whether they are recieving sham or real feedback
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-pulsatile tinnitus for at least 6 months,
- •Bothersome tinnitus, based on a Tinnitus Functional Index score > 25,
- •Normal cognitive processing abilities, based on a Montreal Cognitive Assessment score> 25.
排除标准
- •Clinically diagnosed dementia or Parkinson's disease,
- •Meniere's disease,
- •Severe physical or cognitive impairments that prevent completion of study tasks or scanning,
- •History of drug or alcohol abuse,
- •History of psychological or neurological illness, except for managed anxiety or depression,
- •Severe chronic health problems other than hearing loss or tinnitus,
- •Vision that is not normal or not corrected to normal,
- •Unable to meet MRI clinical safety screening requirements (e.g., metal in the body, pregnancy, certain implantable devices).
结局指标
主要结局
Score on the Tinnitus Functional Index
时间窗: Screening, post-intervention
The Tinnitus Functional Index (TFI) is a 25-item self-report questionnaire designed to measure the impact of tinnitus on an individual's daily life and functioning. The scale produces a global score ranging from 0 to 100, where a minimum score of 0 represents no impact and a maximum score of 100 represents severe impact. Higher scores indicate a worse outcome (greater tinnitus severity and distress).
次要结局
- Score on the Hospital Anxiety and Depression Scale(Screening, post-intervention)
- Percent-change in Functional Connectivity Strength from Baseline to Post-Intervention, participant-level(Pre-intervention, post-intervention)
研究者
Fatima Husain
Professor
University of Illinois at Urbana-Champaign