A Comparative, Randomized Trial on HD-tDCS and Sham Control Group: Effects on Tinnitus Severity and Cognition Including Objective Measures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Tinnitus Functional Index
研究概览
简要总结
This randomized, placebo-controlled study will compare the effects of HD-tDCS (a non-invasive neuromodulation technique) with a sham stimulation. In the sham situation, patients will undergo an identical treatment but no stimulation will be applied, allowing to control for placebo effects. This study will assess the effects of HD-tDCS on chronic, non-pulsatile tinnitus in a reliable way, as confounding factors such as anxiety, depression, hearing impairment, tinnitus gradation, age, and sex will be controlled for. Ultimately, this study will result in final recommendations for a standardised protocol for the use of HD-tDCS in tinnitus patients. When accurate, individualised, and effective therapy is available for the patient, the total cost (both economical and personal) will decrease significantly. The investigation's findings will be relevant for all caretakers dealing with tinnitus patients (psychologists, psychiatrists, manual therapists, general practitioners, ENT specialists, audiologists, etc.).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duration of tinnitus: > 6 months
- •24 < TFI score < 90
- •HADS depression subscale < 12
- •HADS anxiety subscale < 12
- •Hyperacusis questionnaire < 40
- •Dutch- or Flemish-speaking
排除标准
- •Somatic tinnitus
- •Pregnancy
- •Active middle ear pathology
- •Hearing implants
- •Known tumors in the head/neck region
- •Patients having already had any other tinnitus treatment within the last 2 months
研究组 & 干预措施
Active group
tDCS
干预措施: tDCS (Device)
Sham group
Sham tDCS
干预措施: sham tDCS (Device)
结局指标
主要结局
Tinnitus Functional Index
时间窗: 3 months
The Tinnitus Functional Index (TFI) is a self-reported questionnaire, consisting of 25 questions, assessing the impact of tinnitus on patients' daily lives. The patient answers each question on a Likert scale ranging from 0 to 10. Questions 1 and 3 are expressed in percentages, and the Likert scale ranges from 0% to 100% (they are transformed to a 0-10 scale). The total score is then calculated as the mean of all questions multiplied by 10 to express this as a number between 0 and 100. In addition to the total score, the score of eight subscales can be determined. The subscales are the following: intrusiveness, reduced sense of control, cognitive interference, sleep disturbance, auditory difficulties attributed to tinnitus, interference with relaxation, reduced quality of life and emotional distress. A decrease of 13 points on the scale is considered as a clinical relevant difference.
次要结局
- Speech-in-quiet (SPIQ) and speech-in-noise (SPIN) understanding(3 months)
- Speech, Spatial and Qualities of Hearing Scale-12 (SSQ-12)(3 months)
- Visual Analogue Scale (VAS)(3 months)
- Hyperacusis Questionnaire (HQ)(3 months)
- Big Five Inventory-2 (BFI2)(3 months)
- Cortical Auditory Evoked Potentials (CAEP)(3 months)
- Tinnitus Questionnaire (TQ)(3 months)
- Health Utility Index (HUI23)(3 months)
- Repeatable Battery for the Assessment of Neuropsychological Status, adjusted to test Hearing impaired individuals (RBANS-H)(3 months)
- Hospital Anxiety and Depression Scale (HADS)(3 months)
研究者
ethisch.comite@uza.be
Prof dr Annick Gilles (PhD), principal investigator
University Hospital, Antwerp