Transcranial Direct Current Stimulation (tDCS) in Children and Adolescents With Epilepsy and Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-23

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depressive Disorder Generalized Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

transcranial direct current stimulation

Intervention Type DEVICE

The Soterix Medical 1×1 Low Intensity Transcranial DC Stimulator Model 1300A is an investigational device manufactured by Soterix Medical, Inc. (New York, NY, USA). It is designed for use in noninvasive transcranial stimulation of the brain by delivering low-intensity electrical current to the scalp through two electrodes.

Interventions

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transcranial direct current stimulation

The Soterix Medical 1×1 Low Intensity Transcranial DC Stimulator Model 1300A is an investigational device manufactured by Soterix Medical, Inc. (New York, NY, USA). It is designed for use in noninvasive transcranial stimulation of the brain by delivering low-intensity electrical current to the scalp through two electrodes.

Intervention Type DEVICE

Other Intervention Names

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Soterix Medical Model 1300A

Eligibility Criteria

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Inclusion Criteria

* 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

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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No