Transcranial Direct Current to Treat Epilepsy at Home
试验速览
- 阶段
- 早期 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Change in seizures per month
研究概览
简要总结
This is a placebo-controlled study of the effectiveness of transcranial direct current stimulation (tDCS) at home to reduce seizures and EEG spikes.
详细描述
Electrical stimulation is a promising new therapy to reduce seizures, but current methods require inserting wires under the skull or into brain. This project will use direct-current electrical stimulation pulses delivered from scalp electrodes to provide stimulation. The goal is to reduce seizures without the need for surgery.
- PROCEDURES:
2.1. Baseline: Upon signing of consent, subjects will have an initial screening clinic visit with a neurological history and examination. You will record a seizure diary for one month prior to start of stimulation.
2.2. Baseline EEGs: A 2-hour recording will be done with the 256 channel hydrogel electrocap (currently used for clinical studies). Subjects will be maintained awake for consistency, since sleep affects EEG activity.
2.3. Seizure Diary: The subject (and/or family) will maintain a seizure diary during the baseline, treatment, and for one month after their final stimulation treatment. The seizure diary will be reviewed by the study coordinator in a phone contact once per week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Since the subject sets the stimulation settings for each day of treatment, it is not possible to employ a full placebo with this device. We will inform the subjects that we are uncertain whether short stimulation of 1 minute is less effective than is longer stimulation of 30 minutes, which is a true statement according to our current state of knowledge. We will use a balanced deck of randomized cards setting the initial treatment arm as SHORT in 15 cases and LONG in 15 cases.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-100, inclusive.
- •Has a clinical diagnosis of epilepsy
- •Has at least 4 countable seizures per month
- •Has not had control with at least 2 anti-seizure medicines
- •Able to maintain a constant medication for duration of the study (rescue meds allowed)
- •Subject or legally authorized representative is able to understand consent and keep a seizure diary in English
排除标准
- •A disease likely to progress over course of the study
- •Psychogenic non-epileptic seizures
- •Suicide attempt or psychiatric hospitalization past 2 years
- •A skin condition interfering with scalp electrodes or allergy to silver
- •Women will verify not pregnant, and if applicable, have a serum pregnancy test
结局指标
主要结局
Change in seizures per month
时间窗: Recorded at time of study entry (BASELINE) and within 1 week of end of the LONG treatment
Number of seizures recorded in the patient diary
次要结局
- Change in severity of seizures(Within 1 week of end of the SHORT treatment and within 1 week of end of the LONG treatment)
- Change in duration of seizures(Within 1 week of end of the SHORT treatment and within 1 week of end of the LONG treatment)
- Number of epileptiform EEG spikes(Within 1 week of end of the SHORT treatment and within 1 week of end of the LONG treatment)
研究者
Robert S Fisher
Maslah Saul MD Professor of Neurology
Stanford University