Pilot Study of Transcranial Direct Current Stimulation (tDCS) to Treat Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Seizure Count
研究概览
简要总结
The purpose of this research is to see to what extent electrical stimulation applied to the scalp (transcranial direct current stimulation or tDCS) can reduce the number and intensity of epileptic seizures.
详细描述
tDCS for treatment of epilepsy has been studied previously with results suggesting that it can lead to a notable seizure reduction for a limited time period after the cessation of stimulation, e.g., about one month. Here, we assess further aspects of tDCS treatment protocols, including the feasibility and safety of at-home use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of generalized onset or focal epilepsy or sleep-related epileptic encephalopathy.
- •Estimated to have at least 2 countable seizures per month or spike-wave index ≥50%.
- •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.
- •Implanted devices (e.g. pacemakers)-except VNS, which is allowed.
研究组 & 干预措施
tDCS Treatment A (Low Amplitude)
Subjects with focal epilepsy that is not well-controlled on anti-seizure medications will receive 2 different treatments periods, each lasting 2 months, of transcranial direct current stimulation (tDCS). The initial treatment stimulation will be completed during the first 2-months.
干预措施: ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS) (Device)
tDCS Treatment B (High Amplitude)
Subjects with focal epilepsy that is not well-controlled on anti-seizure medications will receive 2 different treatments periods, each lasting 2 months, of transcranial direct current stimulation (tDCS). The last treatment stimulation will be completed during the following 2-months.
干预措施: ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS) (Device)
结局指标
主要结局
Seizure Count
时间窗: 2 months
Number of seizures experienced by subjects as determined by self-reported seizure diary
次要结局
- EEG interictal discharge frequency(2 months)
研究者
Brian N. Lundstrom
Principal Investigator
Mayo Clinic