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

Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03368469
• Other study ID #: 17-001007
• Status: Withdrawn
• Phase: N/A
• Start date: February 23, 2018
• Est. completion date: January 2019

Study information

• Verified date: January 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Epilepsy
• Epilepsy, Generalized
• Generalized Epilepsy

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Depression Rating Scale - Revised (CDRS-R) total score	clinician-rated continuous measure of depression severity based on participant and parent interviews	2 weeks
Secondary	Children's Depression Rating Scale - Revised (CDRS-R) total score	clinician-rated continuous measure of depression severity based on participant and parent interviews	3 months, 6 months
Secondary	Quick Inventory of Depressive Symptoms - Adolescent - Self-Report (QIDS-A17-SR) total score	participant-reported continuous measure of depression severity	day 1, day 5, day 10, 3 months, 6 months
Secondary	tDCS Adverse Effects Survey	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	days 1-10, 2 weeks, 3 months, 6 months
Secondary	Columbia Suicide Severity Rating Scale (C-SSRS)	measure of suicidal ideation and behavior based on clinician interview	day 1, day 5, day 10, 2 weeks, 3 months, 6 months
Secondary	Young Mania Rating Scale (YMRS)	measure of manic symptoms based on clinician interview/observation	day 5, 2 weeks
Secondary	Affective Reactivity Index (ARI)	parent- and participant-report questionnaires regarding symptoms of irritability	2 weeks, 3 months, 6 months
Secondary	Mayo Seizure Frequency Assessment	parent- and participant-report questionnaires regarding seizure frequency	2 weeks, 3 months, 6 months
Secondary	Liverpool Seizure Severity Scale (1998 revision)	parent-/participant-report questionnaire regarding seizure severity and quality	2 weeks, 3 months, 6 months
Secondary	Impact of Pediatric Epilepsy Scale (IPES)	parent-report questionnaire regarding impact of epilepsy of quality of life	2 weeks, 3 months, 6 months
Secondary	Quality of Life in Epilepsy Inventory for Adolescents (QOLIE-AD-48)	participant-report questionnaire regarding impact of epilepsy of quality of life	2 weeks, 3 months, 6 months
Secondary	NIH Toolbox® for Assessment of Neurological and Behavioral Function	validated and age-normed computer-administered battery of measures assessing cognitive functioning	2 weeks
Secondary	Electroencephalography (EEG)	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	2 weeks

External Links

•   Mayo Clinic Clinical Trials