A Double Blind Sham Controlled Trial of tDCS in Treating Schizophrenia and Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Clinical Scales
研究概览
简要总结
The project will investigate the use of a novel technique, transcranial direct current stimulation (tDCS) in the treatment of patients with schizophrenia and patients with depression. tDCS involves the application of an extremely weak continuous electrical current to the brain through the placement of anode and a cathode on the scalp. The electrical current is generally completely imperceptible after initial period of tingling which takes about 30 seconds. Stimulation under the anode appears to increase brain activity where as stimulation under the cathode has the opposite effect. This research plan involves two clinical trials:
- A study using tDCS to treat both the positive and negative symptoms of schizophrenia. The negative symptoms of schizophrenia such as lack of motivation and energy appear to arise due to a lack of activity in frontal brain areas. Positive symptoms such as hallucinations and confused thoughts may arise through over activity of brain areas more on the side and towards the back of the brain called the temporal cortex. We plan to apply tDCS such that it can simultaneously increased activity in these frontal brain areas and reduce activity over temporal cortex. We will compare active stimulation to a placebo condition which involves turning the stimulator off after 30 seconds. The capacity to target multiple symptom clusters is unique with this type of brain stimulation.
- The study using tDCS in treatment resistant depression builds on a work with transcranial magnetic stimulation (TMS). TMS techniques in depression seem to work which increased left frontal brain activity or decrease right frontal brain activity. tDCS will be used to do the same thing with the anode used to increase left-sided brain activity and the cathode used to simultaneously decreased right-sided brain activity.
tDCS is potentially a better tolerated procedure than TMS and does not appear to have the same risk of seizure induction. Importantly, the equipment is quite inexpensive and this may prove to be an extremely safe and effective low-cost treatment for psychiatric disorders in Third World countries.
详细描述
TREATMENT OF MAJOR DEPRESSION USING TRANSCRANIAL DIRECT CURRENT STIMULATION
Rationale:
Depression and tDCS Major depression is a disorder with major clinical and economic significance locally and internationally. It is a disorder of high prevalence and results in substantial disease burden and health-care costs. Critically, a significant percentage of patients, usually estimated at around 30%, fail to respond to standard treatments (Fitzgerald 2003). Techniques such as repetitive transcranial magnetic stimulation (rTMS) are being investigated widely for the treatment of this disorder with considerable success in recent years (Fitzgerald, Benitez et al. 2006)(Hasey 2001). However, TMS equipment is expensive and requires specialist application. Additionally, TMS is associated with some side-effects. Given that depression occurs in all cultures and countries, there would be considerable value in developing a low-cost, non-invasive technique that can be applied in a wide variety of settings, including in the Third World.
RTMS based treatments for depression are based on an understanding that there are abnormalities in activity in frontal brain regions in this disorder (George, Ketter et al. 1994; Fitzgerald, Brown et al. 2003; Speer, Kimbrell et al. 2000). High-frequency stimulation which increases brain activity is usually applied to the left prefrontal cortex in a way that increases activity, although previous literature is somewhat inconsistent. In contrast, low-frequency stimulation which decreases brain activity is applied to the right prefrontal cortex to reduce activity in this region. Both these techniques have therapeutic efficacy (Fitzgerald, Brown et al. 2003). Recent studies, including those conducted by this research group, suggest that a combination of these two approaches is also effective; potentially more effective than either one used independently (Garcia-Toro, Salva et al. 2006; Fitzgerald, 2006).
Transcranial direct current stimulation (tDCS) is a novel, non-invasive and non-convulsive technique for altering brain function (Ardolino, Bossi et al. 2005). It involves the application of a small current (usually 1 to 2 mA) between an anodal and cathodal electrode placed on the scalp (Miranda, Lomarev et al. 2006). Typically, an increase in neuronal excitability occurs under the anode, and a decrease under the cathode, probably through respective depolarisation and hyperpolarisation of neurons (Miranda, Lomarev et al. 2006). It has been shown to be safe in a number of experimental and clinical trials (Fregni, Boggio et al. 2005; Fregni, Boggio et al. 2005; Fregni, Boggio et al. 2006; Fregni, Boggio et al. 2006; Nitsche, Liebetanz et al. 2003; Lang, Nitsche et al. 2004; Boggio, Castro et al. 2006).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schizophrenia
- •Participants will be included if they:
- •Are voluntary and competent to consent;
- •Have a diagnosis of Schizophrenia or Schizoaffective Disorder as confirmed by the Structure Clinical Interview for the DSM-IV (SCID-IV)
- •Have persistent positive and negative symptoms despite having trialled, or being currently medicated, with antipsychotic medication; and
- •are between the ages of 18 and
- •Concomitant medications including:
- •Benzodiazepines,
- •Mood stabilizers (lithium, valproic acid)
- •Antidepressants (including serotonin reuptake inhibitors and tricyclic antidepressants) and anticholinergics will be allowed. Since carbamazepine has been shown to interfere with the effects of anodal tDCS, potential participants taking it will not be suitable for inclusion in the trial.
- •Depression
- •Participants will be included if they:
- •Are competent to consent;
- •Have a diagnosis of Major Depression and are currently experiencing a Major Depressive Episode as confirmed by the Structure Clinical Interview for the DSM-IV (SCID-IV);
- •Are treatment resistant, defined as a failure to achieve a clinical response, or an inability to tolerate, an antidepressant trial of sufficient dose for at least 6 weeks; and
- •Are between the ages of 18 and
- •Concomitant medications including:
- •Benzodiazepines,
- •Mood stabilizers (lithium, valproic acid)
- •Antidepressants (including serotonin reuptake inhibitors and tricyclic antidepressants) and anticholinergics will be allowed. Since carbamazepine has been shown to interfere with the effects of anodal tDCS, potential participants taking it will not be suitable for inclusion in the trial.
排除标准
- •Patients will be excluded if they:
- •Have a DSM-IV history of substance abuse or dependence in the last 6 months;
- •Have a concomitant major and unstable medical or neurologic illness;
- •Are currently taking carbamazepine; or,
- •Are pregnant.
- •Patients will be withdrawn from the study if they:
- •Withdraw consent;
- •Experience significant clinical deterioration;
- •Fail to tolerate the procedure; or,
- •Develop a serious adverse event. In the event that a patient is withdrawn or drops out of the study, efforts will be made to obtain a final set of clinical, cognitive and neurophysiological measures at the time of withdrawal for a last observation carried forward analysis.
结局指标
主要结局
Clinical Scales
时间窗: 3 weeks
次要结局
未报告次要终点