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

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ClinicalTrials.gov Identifier: NCT03368469
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Paul E. Croarkin, Mayo Clinic

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : February 23, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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 Name: Soterix Medical Model 1300A




Primary Outcome Measures :
  1. Children's Depression Rating Scale - Revised (CDRS-R) total score [ Time Frame: 2 weeks ]
    clinician-rated continuous measure of depression severity based on participant and parent interviews


Secondary Outcome Measures :
  1. Children's Depression Rating Scale - Revised (CDRS-R) total score [ Time Frame: 3 months, 6 months ]
    clinician-rated continuous measure of depression severity based on participant and parent interviews

  2. Quick Inventory of Depressive Symptoms - Adolescent - Self-Report (QIDS-A17-SR) total score [ Time Frame: day 1, day 5, day 10, 3 months, 6 months ]
    participant-reported continuous measure of depression severity

  3. tDCS Adverse Effects Survey [ Time Frame: 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

  4. Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: day 1, day 5, day 10, 2 weeks, 3 months, 6 months ]
    measure of suicidal ideation and behavior based on clinician interview

  5. Young Mania Rating Scale (YMRS) [ Time Frame: day 5, 2 weeks ]
    measure of manic symptoms based on clinician interview/observation

  6. Affective Reactivity Index (ARI) [ Time Frame: 2 weeks, 3 months, 6 months ]
    parent- and participant-report questionnaires regarding symptoms of irritability

  7. Mayo Seizure Frequency Assessment [ Time Frame: 2 weeks, 3 months, 6 months ]
    parent- and participant-report questionnaires regarding seizure frequency

  8. Liverpool Seizure Severity Scale (1998 revision) [ Time Frame: 2 weeks, 3 months, 6 months ]
    parent-/participant-report questionnaire regarding seizure severity and quality

  9. Impact of Pediatric Epilepsy Scale (IPES) [ Time Frame: 2 weeks, 3 months, 6 months ]
    parent-report questionnaire regarding impact of epilepsy of quality of life

  10. Quality of Life in Epilepsy Inventory for Adolescents (QOLIE-AD-48) [ Time Frame: 2 weeks, 3 months, 6 months ]
    participant-report questionnaire regarding impact of epilepsy of quality of life

  11. NIH Toolbox® for Assessment of Neurological and Behavioral Function [ Time Frame: 2 weeks ]
    validated and age-normed computer-administered battery of measures assessing cognitive functioning

  12. Electroencephalography (EEG) [ Time Frame: 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



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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368469


Contacts
Contact: Marjorie Gresbrink, MA 507-255-0624 gresbrink.marjorie@mayo.edu
Contact: Paul E Croarkin, DO (507) 293-2557 croarkin.paul@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Marjorie A Gresbrink, MA    507-255-0624    gresbrink.marjorie@mayo.edu   
Contact: Paul E Croarkin, DO    (507) 293-2557    croarkin.paul@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Paul E Croarkin, DO Mayo Clinic

Publications:
Responsible Party: Paul E. Croarkin, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03368469     History of Changes
Other Study ID Numbers: 17-001007
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Paul E. Croarkin, Mayo Clinic:
Transcranial
Stimulation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Epilepsy
Epilepsy, Generalized
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases