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

NCT03368469 | Withdrawn DMC FDA Device

• 1 other identifier: 17-001007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Generalized Epilepsy

Keywords

Transcranial; Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

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

  3 months, 6 months

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

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

• tDCS Adverse Effects Survey

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

• Columbia Suicide Severity Rating Scale (C-SSRS)

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

• Young Mania Rating Scale (YMRS)

  day 5, 2 weeks

Study Arms (1)

transcranial direct current stimulation

EXPERIMENTAL

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

Interventions

transcranial direct current stimulation DEVICE

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.

Also known as: Soterix Medical Model 1300A

transcranial direct current stimulation

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (5)

• 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.

  PMID: 28638351 BACKGROUND

• 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.

  PMID: 28229395 BACKGROUND

• 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.

  PMID: 27027666 BACKGROUND

• 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.

  PMID: 28751225 BACKGROUND

• 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.

  PMID: 25499471 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Depressive Disorder; Epilepsy, Generalized

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Paul E Croarkin, DO

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 11, 2017
• Study Start: February 23, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (1)