A Pilot Study of the Tolerability and Efficacy of Transcranial Direct Current Stimulation (tDCS) in Children and Adolescents With Epilepsy and Comorbid Depression
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 1
- 主要终点
- Children's Depression Rating Scale - Revised (CDRS-R) total score
研究概览
简要总结
The proposed study seeks to obtain preliminary signal of the tolerability and efficacy of transcranial direct current stimulation (tDCS) for depressive symptoms in a sample of adolescents with depression and epilepsy. Additionally, effects of tDCS will be assessed via electroencephalographic, cognitive, and psychosocial measures.
详细描述
Transcranial direct current stimulation (tDCS) has been investigated extensively in recent years for the treatment of depression. Meta-analysis of individual patient data indicates that tDCS results in improvement in depressive symptoms, with efficacy comparable to antidepressant medications and repetitive transcranial magnetic stimulation (rTMS), while tDCS offers advantages over other treatments, including side effect profile, cost, and portability. tDCS has been employed to a more limited extent in children and adolescents for psychiatric conditions other than depression, as well as in both adults and children with epilepsy, with excellent tolerability and a mild adverse effect profile. The proposed protocol aims to extend the use of tDCS for treatment of depression in children with epilepsy (CWE), a population with a very high prevalence of depression and a significant need for additional treatment options, particularly nonpharmacologic treatments, due to challenges with the use of antidepressant medications and other non-invasive brain stimulation (NIBS) techniques in CWE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of generalized epilepsy (confirmed by neurologist)
- •Diagnosis of depressive disorder (confirmed by psychiatrist), with CDRS-R score ≥ 40
- •Parent/guardian ability to provide written informed consent in English, with child/adolescent participant able to provide assent (for participants <18 years of age), or participant ability to provide written informed consent in English (for participants ≥18 years of age)
- •Antidepressant medications (SSRI or SNRI) permitted, provided that no dosing change has occurred in two months prior to baseline assessments; antidepressant medication not required for enrollment
- •AED medications (with exceptions listed below in
排除标准
- •) permitted, provided that no change in AED regimen has occurred in two months prior to baseline assessments (except for weight/growth-related dosing changes); AED not required for enrollment
- •Exclusion Criteria:
- •Presence of pacemaker or metallic implant (with the exception of orthodontic hardware)
- •Prior surgical intervention for epilepsy
- •More than one generalized tonic-clonic (GTC) seizure during two months prior to enrollment
- •AED regimen change during two months prior to baseline assessments (except dosing adjustments made strictly due to growth/weight change)
- •Antidepressant medication change during two months prior to baseline assessments
- •Lifetime history of manic/hypomanic episode or psychotic disorder
- •Autism spectrum disorder (ASD) diagnosis
- •Documented history of intellectual disability (documented full-scale IQ greater than two standard deviations below mean)
- •Current or recent (two months prior to baseline assessments) active substance use disorder
- •Imminent risk of suicide or medically serious self-injurious behavior (as evaluated by board-certified child and adolescent psychiatrist)
- •Current pregnancy or positive urine pregnancy test
- •Prohibited concomitant medications include: regularly scheduled benzodiazepines (except clobazam); barbiturates; neuroleptic/antipsychotic medications; lithium.
研究组 & 干预措施
transcranial direct current stimulation
Transcranial direct current stimulation (35 sq cm anode over left dorsolateral prefrontal cortex, 35 sq cm cathode over right supraorbital area, 1 mA current, 20 min per treatment session, 1 session per day, 10 treatment sessions over two weeks)
干预措施: transcranial direct current stimulation (Device)
结局指标
主要结局
Children's Depression Rating Scale - Revised (CDRS-R) total score
时间窗: 2 weeks
clinician-rated continuous measure of depression severity based on participant and parent interviews
次要结局
- Quick Inventory of Depressive Symptoms - Adolescent - Self-Report (QIDS-A17-SR) total score(day 1, day 5, day 10, 3 months, 6 months)
- Young Mania Rating Scale (YMRS)(day 5, 2 weeks)
- Affective Reactivity Index (ARI)(2 weeks, 3 months, 6 months)
- Mayo Seizure Frequency Assessment(2 weeks, 3 months, 6 months)
- Children's Depression Rating Scale - Revised (CDRS-R) total score(3 months, 6 months)
- Columbia Suicide Severity Rating Scale (C-SSRS)(day 1, day 5, day 10, 2 weeks, 3 months, 6 months)
- tDCS Adverse Effects Survey(days 1-10, 2 weeks, 3 months, 6 months)
- Quality of Life in Epilepsy Inventory for Adolescents (QOLIE-AD-48)(2 weeks, 3 months, 6 months)
- Liverpool Seizure Severity Scale (1998 revision)(2 weeks, 3 months, 6 months)
- Impact of Pediatric Epilepsy Scale (IPES)(2 weeks, 3 months, 6 months)
- NIH Toolbox® for Assessment of Neurological and Behavioral Function(2 weeks)
- Electroencephalography (EEG)(2 weeks)
研究者
Paul E. Croarkin
Principal Investigator
Mayo Clinic