Clinical trial NCT03368469: Transcranial Direct Current Stimulation (tDCS) in Children and Adolescents With Epilepsy and Depression
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depressive Disorder
Generalized Epilepsy
Keywords: Transcranial
Stimulation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Children's Depression Rating Scale - Revised (CDRS-R) total score
timeFrame: 2 weeks
Secondary outcomes:
measure: Children's Depression Rating Scale - Revised (CDRS-R) total score
timeFrame: 3 months, 6 months
measure: Quick Inventory of Depressive Symptoms - Adolescent - Self-Report (QIDS-A17-SR) total score
timeFrame: day 1, day 5, day 10, 3 months, 6 months
measure: tDCS Adverse Effects Survey
timeFrame: days 1-10, 2 weeks, 3 months, 6 months
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: day 1, day 5, day 10, 2 weeks, 3 months, 6 months
measure: Young Mania Rating Scale (YMRS)
timeFrame: day 5, 2 weeks
measure: Affective Reactivity Index (ARI)
timeFrame: 2 weeks, 3 months, 6 months
measure: Mayo Seizure Frequency Assessment
timeFrame: 2 weeks, 3 months, 6 months
measure: Liverpool Seizure Severity Scale (1998 revision)
timeFrame: 2 weeks, 3 months, 6 months
measure: Impact of Pediatric Epilepsy Scale (IPES)
timeFrame: 2 weeks, 3 months, 6 months
measure: Quality of Life in Epilepsy Inventory for Adolescents (QOLIE-AD-48)
timeFrame: 2 weeks, 3 months, 6 months
measure: NIH Toolbox® for Assessment of Neurological and Behavioral Function
timeFrame: 2 weeks
measure: Electroencephalography (EEG)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Paul E Croarkin, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JC, Lewis CP, Daskalakis ZJ, Croarkin PE. Transcranial Direct Current Stimulation: Considerations for Research in Adolescent Depression. Front Psychiatry. 2017 Jun 7;8:91. doi: 10.3389/fpsyt.2017.00091. eCollection 2017.
citation: Hameed MQ, Dhamne SC, Gersner R, Kaye HL, Oberman LM, Pascual-Leone A, Rotenberg A. Transcranial Magnetic and Direct Current Stimulation in Children. Curr Neurol Neurosci Rep. 2017 Feb;17(2):11. doi: 10.1007/s11910-017-0719-0.
citation: Muszkat D, Polanczyk GV, Dias TG, Brunoni AR. Transcranial Direct Current Stimulation in Child and Adolescent Psychiatry. J Child Adolesc Psychopharmacol. 2016 Sep;26(7):590-7. doi: 10.1089/cap.2015.0172. Epub 2016 Mar 30.
citation: Godinho MM, Junqueira DR, Castro ML, Loke Y, Golder S, Neto HP. Safety of transcranial direct current stimulation: Evidence based update 2016. Brain Stimul. 2017 Sep-Oct;10(5):983-985. doi: 10.1016/j.brs.2017.07.001. Epub 2017 Jul 8. No abstract available.
citation: Krishnan C, Santos L, Peterson MD, Ehinger M. Safety of noninvasive brain stimulation in children and adolescents. Brain Stimul. 2015 Jan-Feb;8(1):76-87. doi: 10.1016/j.brs.2014.10.012. Epub 2014 Oct 28.