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

Sponsor

Mayo Clinic (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03368469

Collaborator

(none)

Enrollment

Location

Arm

10.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder Generalized Epilepsy	Device: transcranial direct current stimulation	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pilot Study of the Tolerability and Efficacy of Transcranial Direct Current Stimulation (tDCS) in Children and Adolescents With Epilepsy and Comorbid Depression

Actual Study Start Date :

Feb 23, 2018

Anticipated Primary Completion Date :

Jan 1, 2019

Anticipated Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	Device: 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. Other Names: Soterix Medical Model 1300A

Arm

Intervention/Treatment

Experimental: 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)

Device: 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.

Other Names:

Soterix Medical Model 1300A

Outcome Measures

Primary Outcome Measures

Children's Depression Rating Scale - Revised (CDRS-R) total score [2 weeks]
clinician-rated continuous measure of depression severity based on participant and parent interviews

Secondary Outcome Measures

Children's Depression Rating Scale - Revised (CDRS-R) total score [3 months, 6 months]
clinician-rated continuous measure of depression severity based on participant and parent interviews
Quick Inventory of Depressive Symptoms - Adolescent - Self-Report (QIDS-A17-SR) total score [day 1, day 5, day 10, 3 months, 6 months]
participant-reported continuous measure of depression severity
tDCS Adverse Effects Survey [days 1-10, 2 weeks, 3 months, 6 months]
standardized self-report questionnaire for active reporting of adverse effects; will be used to calculate incidence of all adverse effects (AEs) and severe adverse effects (SAEs) as well as incidence of specific AEs/SAEs
Columbia Suicide Severity Rating Scale (C-SSRS) [day 1, day 5, day 10, 2 weeks, 3 months, 6 months]
measure of suicidal ideation and behavior based on clinician interview
Young Mania Rating Scale (YMRS) [day 5, 2 weeks]
measure of manic symptoms based on clinician interview/observation
Affective Reactivity Index (ARI) [2 weeks, 3 months, 6 months]
parent- and participant-report questionnaires regarding symptoms of irritability
Mayo Seizure Frequency Assessment [2 weeks, 3 months, 6 months]
parent- and participant-report questionnaires regarding seizure frequency
Liverpool Seizure Severity Scale (1998 revision) [2 weeks, 3 months, 6 months]
parent-/participant-report questionnaire regarding seizure severity and quality
Impact of Pediatric Epilepsy Scale (IPES) [2 weeks, 3 months, 6 months]
parent-report questionnaire regarding impact of epilepsy of quality of life
Quality of Life in Epilepsy Inventory for Adolescents (QOLIE-AD-48) [2 weeks, 3 months, 6 months]
participant-report questionnaire regarding impact of epilepsy of quality of life
NIH Toolbox® for Assessment of Neurological and Behavioral Function [2 weeks]
validated and age-normed computer-administered battery of measures assessing cognitive functioning
Electroencephalography (EEG) [2 weeks]
objective electrophysiologic data on brain activity; a board-certified epileptologist will manually quantify the maximal number of spike-wave discharges per 20-second recording, the longest run of epileptiform discharges, and, if sleep EEG is obtained, the spike-wave index; additionally, broadband EEG will be obtained to assess indices of cortical excitability, such as relationships between slow oscillations, interictal epileptiform discharges, and sleep architecture

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.