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

Primary Purpose

Depressive Disorder, Generalized Epilepsy

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

transcranial direct current stimulation

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Transcranial, Stimulation

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

transcranial direct current stimulation

Arm Description

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)

Outcomes

Primary Outcome Measures

Children's Depression Rating Scale - Revised (CDRS-R) total score

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

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

participant-reported continuous measure of depression severity

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

Columbia Suicide Severity Rating Scale (C-SSRS)

measure of suicidal ideation and behavior based on clinician interview

Young Mania Rating Scale (YMRS)

measure of manic symptoms based on clinician interview/observation

Affective Reactivity Index (ARI)

parent- and participant-report questionnaires regarding symptoms of irritability

Mayo Seizure Frequency Assessment

parent- and participant-report questionnaires regarding seizure frequency

Liverpool Seizure Severity Scale (1998 revision)

parent-/participant-report questionnaire regarding seizure severity and quality

Impact of Pediatric Epilepsy Scale (IPES)

parent-report questionnaire regarding impact of epilepsy of quality of life

Quality of Life in Epilepsy Inventory for Adolescents (QOLIE-AD-48)

participant-report questionnaire regarding impact of epilepsy of quality of life

NIH Toolbox® for Assessment of Neurological and Behavioral Function

validated and age-normed computer-administered battery of measures assessing cognitive functioning

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

Full Information

NCT ID

NCT03368469

First Posted

December 1, 2017

Last Updated

January 15, 2020

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03368469

Brief Title

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

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Withdrawn

Why Stopped

The study team was unable to recruit and enroll subjects. The study is now closed.

Study Start Date

February 23, 2018 (Actual)

Primary Completion Date

January 2019 (Anticipated)

Study Completion Date

January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Generalized Epilepsy

Keywords

Transcranial, Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

transcranial direct current stimulation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

transcranial direct current stimulation

Other Intervention Name(s)

Soterix Medical Model 1300A

Intervention Description

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.

Primary Outcome Measure Information:

Title

Children's Depression Rating Scale - Revised (CDRS-R) total score

Description

clinician-rated continuous measure of depression severity based on participant and parent interviews

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Children's Depression Rating Scale - Revised (CDRS-R) total score

Description

clinician-rated continuous measure of depression severity based on participant and parent interviews

Time Frame

3 months, 6 months

Title

Quick Inventory of Depressive Symptoms - Adolescent - Self-Report (QIDS-A17-SR) total score

Description

participant-reported continuous measure of depression severity

Time Frame

day 1, day 5, day 10, 3 months, 6 months

Title

tDCS Adverse Effects Survey

Description

Time Frame

days 1-10, 2 weeks, 3 months, 6 months

Title

Columbia Suicide Severity Rating Scale (C-SSRS)

Description

measure of suicidal ideation and behavior based on clinician interview

Time Frame

day 1, day 5, day 10, 2 weeks, 3 months, 6 months

Title

Young Mania Rating Scale (YMRS)

Description

measure of manic symptoms based on clinician interview/observation

Time Frame

day 5, 2 weeks

Title

Affective Reactivity Index (ARI)

Description

parent- and participant-report questionnaires regarding symptoms of irritability

Time Frame

2 weeks, 3 months, 6 months

Title

Mayo Seizure Frequency Assessment

Description

parent- and participant-report questionnaires regarding seizure frequency

Time Frame

2 weeks, 3 months, 6 months

Title

Liverpool Seizure Severity Scale (1998 revision)

Description

parent-/participant-report questionnaire regarding seizure severity and quality

Time Frame

2 weeks, 3 months, 6 months

Title

Impact of Pediatric Epilepsy Scale (IPES)

Description

parent-report questionnaire regarding impact of epilepsy of quality of life

Time Frame

2 weeks, 3 months, 6 months

Title

Quality of Life in Epilepsy Inventory for Adolescents (QOLIE-AD-48)

Description

participant-report questionnaire regarding impact of epilepsy of quality of life

Time Frame

2 weeks, 3 months, 6 months

Title

NIH Toolbox® for Assessment of Neurological and Behavioral Function

Description

validated and age-normed computer-administered battery of measures assessing cognitive functioning

Time Frame

2 weeks

Title

Electroencephalography (EEG)

Description

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul E Croarkin, DO

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28638351

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.

Results Reference

background

PubMed Identifier

28229395

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.

Results Reference

background

PubMed Identifier

27027666

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.

Results Reference

background

PubMed Identifier

28751225

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.

Results Reference

background

PubMed Identifier

25499471

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.

Results Reference

background

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

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