The Transcranial Direct Current Stimulation Treatment of Tinnitus and Its Psychiatric Comorbidities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Tinnitus Functional Index (TFI) at T1 (baseline)
研究概览
简要总结
The study was designed to evaluate a therapeutic effect of tDCS in the treatment of tinnitus and its comorbidities (anxiety, depresion) and to evaluate the associated quality of life.
In the randomized, double-blinded, sham-controlled trial, 39 participants (active n=19, sham n=20) underwent bilateral dorsolateral prefrontal cortex (DLPFC) tDCS (anode over right DLPFC, cathode left DLPFC, current of 1.5 mA, 20 minutes, 6 sessions in 2 weeks). Tinnitus Functional Index (TFI), Iowa Tinnitus Handicap Questionnaire (ITHQ), Beck Anxiety Inventory (BAI), Zung Self-Rating Depression Scale (SDS), and WHO-Quality of Life-BREF were employed in 4 evaluation points, including the follow-ups of 6 weeks and six months.
详细描述
A prospective, randomized, double-blinded, placebo-controlled, two-arm trial was conducted at the Department of Psychiatry, General University Hospital in Prague, Czechia. The research was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of General University Hospital in Prague, Czechia, in 2019 under the reference number 531/19 S-IV.
Participants were recruited through the recruitment campaign of the Department of Psychiatry, which was supported by outpatient services of several neurological, psychiatric, internal, and otorhinolaryngological departments in several university hospitals around Prague. All participants were required to sign written consent with the trial, anonymized data, the European Union General Data Protection Regulation (GDPR), and were fully informed about the trial's goals, risks, and requirements. Participation was not associated with any financial reward.
The participation was offered to persons at least 18 years of age (on the day of signing the consent) with a history of tinnitus lasting at least six months. The investigators excluded persons contraindicated to tDCS - such as those with epilepsy, intracranial masses or metallic objects, pregnancy, and heart conditions. The investigators also excluded persons with a history of alcohol and drug abuse, persons unwilling to sign the informed consent or persons who underwent any other tinnitus therapy in the last six months. The investigators intended to discontinue the treatment in any participant developing any severe adverse effect (significant exacerbation of tinnitus, epileptic seizure, severe headache, or any adverse effect deemed severe enough by the participants) and in participants noncompliant or unwilling to participate further with the trial and its follow-ups. The investigators required the participants not to alter their medication at least six months before the trial if any was used.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participants were distributed between 2 arms using an aperiodic, nondeterministic, atmospheric random noise randomization algorithm. The stimulation type was unblinded upon completing all the follow-ups or dropping out. The blinding was ensured by a dedicated team member with no direct access to the participants or their data.
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
- •Nonpulsatile tinnitus for at least 6 months
- •18 and more years of age
排除标准
- •Pregnancy
- •Unstable cardiovascular condition
- •History of seizures
- •Intracranial masses
- •Intracranial metalic objects
- •History of alcohol or drug abuse
- •Unwillingness to sign the informed consent
- •Inability to pass the follow-up
- •Unstable medication for at least 6 months prior to the enrollment
- •Other stimulation method for at least 6 months prior to the enrollmment
结局指标
主要结局
Tinnitus Functional Index (TFI) at T1 (baseline)
时间窗: The measurement was established as a baseline prior to the stimulation series. (at T1)
A questionaire evaluating 8 subdomains of tinnitus. A total minimal score=0, maximum score=250. Higher score means generally more severe form of tinnitus.
Changes in Tinnitus Functional Index (TFI) at T2
时间窗: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes compared to the baseline (T2-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in Tinnitus Functional Index (TFI) at T3
时间窗: Measured at T3 (6 weeks since T1)
Changes compared to the baseline (T3-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in Tinnitus Functional Index (TFI) at T4
时间窗: Measured at T4 (6 months since T1)
Changes compared to the baseline (T4-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Iowa Tinnitus Handicap Questionnaire version 1 (ITHQ) at T1 (baseline)
时间窗: The measurement was established as a baseline prior to the stimulation series. (at T1)
A questionnaire evaluating 3 subdomains of tinnitus and its handicap. A total minimal score=0 %, maximum score=100%. Higher score means generally more severe form of tinnitus.
Changes in Iowa Tinnitus Handicap Questionnaire version 1 (ITHQ) at T2
时间窗: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes compared to the baseline (T2-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in Iowa Tinnitus Handicap Questionnaire version 1 (ITHQ) at T3
时间窗: Measured at T3 (6 weeks since T1)
Changes compared to the baseline (T3-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in Iowa Tinnitus Handicap Questionnaire version 1 (ITHQ) at T4
时间窗: Measured at T4 (6 months since T1)
Changes compared to the baseline (T4-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Beck Anxiety Inventory (BAI) at T1 (baseline)
时间窗: The measurement was established as a baseline prior to the stimulation series. (at T1)
A standardized questionaire to evaluate the symptoms of anxiety. Minimum=0 points, maximum=63 points. A higher score means generally more severe anxiety.
Changes in Beck Anxiety Inventory (BAI) at T2
时间窗: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes compared to the baseline (T2-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in Beck Anxiety Inventory (BAI) at T3
时间窗: Measured at T3 (6 weeks since T1)
Changes compared to the baseline (T3-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in Beck Anxiety Inventory (BAI) at T4
时间窗: Measured at T4 (6 months since T1)
Changes compared to the baseline (T4-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Zung Self-Rating Depression Scale (SDS) at T1 (baseline)
时间窗: The measurement was established as a baseline prior to the stimulation series. (at T1)
A standardized questionaire focusing on symptoms of depression. The scale calculates SDS index from the raw data - minimal SDS index=25 points; maximal SDS index=100 points. Higher SDS index means generally more severe depression.
Changes in Zung Self-Rating Depression Scale (SDS) at T2
时间窗: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes compared to the baseline (T2-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in Zung Self-Rating Depression Scale (SDS) at T3
时间窗: Measured at T3 (6 weeks since T1)
Changes compared to the baseline (T3-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in Zung Self-Rating Depression Scale (SDS) at T4
时间窗: Measured at T4 (6 months since T1)
Changes compared to the baseline (T4-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
The World Health Organization Quality Of Life (WHOQOL)-BREF at T1 (baseline)
时间窗: The measurement was established as a baseline prior to the stimulation series. (at T1)
An abbreviated version of WHO questionaire evaluating 4 domains of quality of life during the therapy. The outcomes are calculatefd are on a scale ranging between 0-100%. Higher scores mean generally higher perceived quality of life.
Changes in The World Health Organization Quality Of Life (WHOQOL)-BREF at 2
时间窗: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Changes compared to the baseline (T2-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in The World Health Organization Quality Of Life (WHOQOL)-BREF at 3
时间窗: Measured at T3 (6 weeks since T1)
Changes compared to the baseline (T3-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
Changes in The World Health Organization Quality Of Life (WHOQOL)-BREF at 4
时间窗: Measured at T4 (6 months since T1)
Changes compared to the baseline (T4-T1) were calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement.
次要结局
未报告次要终点
研究者
Jozef Buday
Head of the Neurostimulation Center; Assistant Professor
Charles University, Czech Republic