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

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.

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

- AED medications (with exceptions listed below in exclusion criteria) 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.