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临床试验/NCT03550430
NCT03550430已完成不适用

Study Protocol for a Single-blind Randomized Controlled Trial, Assessing the Specificity of an Alpha/Delta Ratio Neurofeedback Training Protocol in Chronic Tinnitus.

Philipps University Marburg Medical Center1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Tinnitus Magnitude Index (TMI; Schmidt, Kerns, Griest, Theodoroff, Pietrzak, & Henry, 2014).

研究概览

简要总结

This study will evaluate the efficacy of an alpha/delta ratio (ADR) neurofeedback training protocol on tinnitus distress. 1/3 of the participants in the study will undergo ADR neurofeedback training, 1/3 an active comparator, beta/theta ratio (BTR) neurofeedback training, whilst the final 1/3 of participants will fill in daily diaries of tinnitus complaints and symptoms for two weeks.

详细描述

Tinnitus is hypothesized to originate as a result of a disturbance in the balance of excitatory and inhibitory neurons in central auditory structures. More specifically, inhibitory neurons hyperpolarize, by which their functional role is weakened . Consequently, this allows auditory neurons, deprived of input from a lesioned auditory system, to spontaneously synchronize their activity, resulting in the tinnitus percept.

In the normal functioning auditory system, neurons firing synchronously in the alpha frequency region (8 - 12 Hz) have a gating function of inhibiting task-irrelevant regions in the brain. In people with chronic tinnitus, it has been observed, that alpha activity over temporal regions is weakened, thus leading to the spontaneous activity characterizing the condition. By upregulating alpha activity with neurofeedback training, it is hypothesized that the excitatory/inhibitory balance in temporal regions can be restored, thus minimizing the tinnitus percept.

The coupling or exchange of information of distinct brain regions, leading to an integrated conscious perception, is assumed to be mediated by delta oscillations. In tinnitus, the distress associated with the condition arises as a consequence of coupling prefrontal areas, responsible for allocation of attentional resources with limbic (arousal) and temporal (auditory processing) regions. In neurofeedback, the downregulation of delta activity is hypothesized to lead to a de-coupling of the communication between the areas associated with the distress.

No studies to date have tested the specific role of alpha and delta in the origin and perpetuation of tinnitus distress and intrusiveness. The present study seeks to compensate for this, by comparing an alpha and delta neurofeedback ratio training protocol with one assumed to have no direct association with the pathophysiology of tinnitus.

In addition to the ten neurofeedback training sessions, all participants undergo diagnostic assessments at three time points throughout the trial (pre-neurofeedback training, post-neurofeedback training and at three months follow-up). For the first 40 participants, electroencephalographic (EEG) activity is recorded and cognitive capacity assessed with two attention tests, the Attention Network Test and Sustained Attention Response Task, respectively at all three time points. For the remaining 80 participants, the EEG recording is abandoned, and only cognitive capacity assessed in the pre- post, and follow-up phase of the study.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Chronic subjective tinnitus, i.e. tinnitus with a duration > 6 months
  • •At least mild tinnitus distress, corresponding to a score of ≥ 18 on the Tinnitus Handicap Inventory

排除标准

  • •Moderately severe or severe depression
  • •Objective tinnitus, where causes are classified according to whether they are vascular or non-vascular in origin
  • •Current use of psychotropic drugs for a mental health condition
  • •Bipolar disorder, Attention Deficit Hyperactivity Disorder (ADHD), Psychosis
  • •Substance abuse
  • •Current psychotherapeutic treatment for tinnitus, previous biofeedback- or neurofeedback treatment
  • •A history of seizures, strokes and/or brain hemorrhages

研究组 & 干预措施

ADR neurofeedback

Experimental

Ten ADR neurofeedback training sessions. The first five sessions comprise four training blocks. The latter five sessions consists of five training blocks each. All training blocks are seven minutes in duration. Participants take between two to three sessions each week.

干预措施: alpha/delta neurofeedback (Behavioral)

BTR neurofeedback

Active Comparator

Ten BTR neurofeedback training sessions. The first five sessions comprise four training blocks. The latter five sessions each consists of five training blocks. All training blocks are seven minutes in duration. Participants take between two to three sessions each week.

干预措施: beta/theta neurofeedback (Behavioral)

Diary Control Group

Active Comparator

Daily diary completion for two weeks in the period between baseline and end-point assessments (total period baseline to end-point = four weeks).

干预措施: Diary completion (Other)

结局指标

主要结局

Tinnitus Magnitude Index (TMI; Schmidt, Kerns, Griest, Theodoroff, Pietrzak, & Henry, 2014).

时间窗: 16 weeks

TMI measures tinnitus intensity, three-item scale assessing self-reported severity, loudness and awareness. - Visual analogue scale ranges from 0-10 or 0-100, respectively: item 1 (loudness): Range 0 (not at all strong or loud) to 10 (extremely strong or loud) item 2 (awareness): 0 to 100 in increments of 10, with verbal anchors of 0="never aware" and 100="always aware" item 3 (severity): 0-100 with verbal anchors of 0="no tinnitus present" to 100="the worst tinnitus you can imagine" * for all items higher values indicate higher tinnitus magnitude * values of the three items can be summed up to a total score. For standardisation, items are converted from 0-100 to 0-10.

Tinnitus Handicap Inventory (THI; Newman, Sandridge, & Jacobson, 1998)

时间窗: 16 weeks

Self-report measure of tinnitus handicap assessed pre-intervention, mid-treatment (five sessions), post-intervention and at three month follow-up. The Tinnitus Handicap Inventory is a 25 item questionnaire. Each item is scored 0 - 4 (0 = No, 2 = Sometimes, 4 = Yes), yielding a total between 0 (no handicap) - 100 (catastrophic impact).

次要结局

  • Credibility and Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)(4 weeks)
  • Attention Network Test (ANT; Fan, McCandliss, Sommer, Raz, & Posner, 2002)(16 weeks)
  • Brief Illness Perception Questionnaire (B-IPQ; Broadbent, Petrie, Main, & Weinman, 2006)(4 weeks)
  • Insomnia Severity Index (ISI; Bastien, Vallières, & Morin, 2001)(4 weeks)
  • Tinnitus Functional Index (TFI; Brüggemann, Szczepek, Kleinjung, Ojo, & Mazurek, 2017)(16 weeks)
  • Sustained Attention Response Task (SART; Robertson, Manly, Andrade, Baddeley, & Yiend, 1997)(16 weeks)
  • Patient Health Questionnaire (PHQ-9; Gräfe, Zipfel, Herzog, & Löwe, 2004)(16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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