跳至主要内容
临床试验/NCT02268578
NCT02268578撤回1 期

Efficacy of Transcranial Direct Current Stimulation for Treating Working Memory Dysfunction and Depression For Patients With Temporal Lobe Epilepsy

NYU Langone Health1 个研究点 分布在 1 个国家开始时间: 2012年11月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
撤回
试验地点
1
主要终点
Change in EEG Power

研究概览

简要总结

Memory difficulty ranks among the most common complaints for patients with temporal lobe epilepsy. While these cognitive problems may affect quality of life more than seizure frequency, no effective therapy exists. Transcranial Direct Current Stimulation (tDCS) is a method of safe, noninvasive, and painless brain stimulation delivering low intensity direct current through scalp electrodes to modulate brain activity. Several recently published studies demonstrate the enhancement of working memory and mood with stimulation of the frontal region of the brain. Furthermore, tDCS has never been reported to have induced a seizure. The aim of our study is to determine whether real tDCS can improve memory function and mood. The investigators are enrolling patients with well-controlled temporal lobe epilepsy who have not undergone brain surgery.

详细描述

Transcranial direct current stimulation (tDCS) is a powerful technique to modulate brain activity:

TDCS is based on the application of a weak direct current to the scalp that flows between two relatively large electrodes-anode and cathode. During tDCS, low amplitude (1-2 mA), constant currents are applied via the scalp electrodes and penetrate the skull to enter the brain. Although there is substantial shunting of current in the scalp, sufficient current penetrates the brain to modify the trans-membrane neuronal potential as shown by two recent modeling studies (Miranda et al. 2006; Wagner et al. 2007a), and thus influence the level of excitability and modulate the firing rate of individual neurons. When tDCS is applied for a sufficient duration, cortical function can be altered beyond the stimulation period (Nitsche and Paulus 2001) and the direction of the cortical excitability changes depends on current orientation.

Several well-conducted animal studies on the effects of tDCS dating back to the 1950s and 60s showed that tDCS is a powerful technique to modulate brain function. These studies demonstrated that polarizing currents applied to the surface of the brain result in a modulation of the cortical activity. Surface anodal polarization of the cortex increases spontaneous unit discharges (Burns 1954; Creutzfeld et al. 1962) and initiates paroxysmal activity (Goldring and O'Leary 1951), whereas cathodal polarization generally depresses these events. Furthermore, low-level surface polarization facilitates acquisition of learned motor responses and induces prolonged changes in patterns of evoked cortical unit discharges (Bindman et al. 1964). Finally, Purpura et al. (1964), studying pyramidal tract cells from cats, showed that prolonged periods of polarization may produce progressive membrane and post-synaptic potential changes as well as after-effects (Purpura and McMurtry 1965).

Based on this evidence, recent human studies have been performed and collectively have shown that motor cortex (M1) stimulation with tDCS changes motor cortex excitability depending on the stimulation polarity: while anodal stimulation increases cortical excitability, cathodal stimulation decreases it (Nitsche et al. 2003; Nitsche and Paulus 2000; Nitsche and Paulus 2001). Similar modulatory effects have also been described in the visual cortex (Antal et al. 2004; Antal et al. 2001). A recent tDCS study has shown that anodal tDCS of the primary motor cortex not only affects cortical activity, but induces significant changes on thalamic activity (Lang et al. 2005). It should be noted that application of tDCS in humans has advanced significantly in the last 10 years and it is therefore different from the human application used in the '60s and '70s (Wagner et al. 2007b)

Furthermore, tDCS offers several advantages as compared with other techniques of noninvasive brain stimulation (i.e., repetitive transcranial magnetic stimulation (rTMS)): (1) small size of the electrodes and stimulator, thus allowing portable use for instance to be used at home, (2) simple and non-expensive technique that can easily be translated for use in clinical practice, (3) long-lasting effects - the modulatory effects of tDCS last longer as compared to rTMS - for instance, 13 minutes of stimulation changes brain excitability for up to 2 hours (Nitsche and Paulus 2001), and (4) more easily blinded with sham tDCS in the setting of clinical trials (Gandiga 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, Investigator)

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

  • •age between 18-70 years
  • •diagnosis of temporal lobe epilepsy, with seizure focus defined by seizure semiology, EEG, MRI Brain, PET and/or ictal and interictal SPECT.
  • •Must have a stable seizure frequency in the two (2) months prior to enrollment, as verified by the patient's seizure log and/or clinic notes and without recent antiepileptic medication changes.
  • •Must score above 22/30 on the Montreal Cognitive Assessment (MoCA).
  • •Must be able to provide informed consent.

排除标准

  • •Patient has a progressive or unstable neurological or systemic disease
  • •Patient has an ictal focus over the F3 or F4 (DLPFC) field
  • •Patient has a history of severe depression, as determined by a screen inventory test such as the Beck Depression Inventory or a psychiatrist
  • •Patient has a history of severe traumatic brain injury or prior brain surgery with skull defect
  • •Contraindictations to tDCS, including metal in the head or implanted brain medical devices
  • •Any implanted electrical medical device, including pacers and implanted cardiac defibrillators
  • •History of schizophrenia, schizoaffective disorder, other psychosis, rapid-cycling bipolar illness, alcohol/drug abuse within the past year
  • •History of dementia

研究组 & 干预措施

Transcranial Direct Current Stimulation

Active Comparator

Subjects will receive a total of 5 sessions on consecutive days. During each session, 2 mA of tDCS will be applied for 20 minutes over the left DLPFC (active or sham). The electrodes will have the size of 35cm2 each. Direct current will be transferred by a saline-soaked pair of surface sponge electrodes and delivered b y a specially developed, battery driven, constant current stimulator with a maximum output of 2mA.

干预措施: Transcranial Direct Current Stimulation (Device)

Sham TDCS

Sham Comparator

For sham-controlled tDCS subjects, the same montage will be used; however current will be applied for only 30 seconds - this is a reliable method of sham stimulation as sensations arising from tDCS treatment occur only at the beginning of application as also demonstrated by a randomized study (Gandiga et al. 2006).

干预措施: Sham Transcranial Direct Current Stimulation (Procedure)

结局指标

主要结局

Change in EEG Power

时间窗: Visits 1, 5, 6 & 7 over 5 weeks

次要结局

  • Cognitive Tests(Visits 1, 5, 6 & 7 over 5 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验