An interventional study of transcranial direct current stimulation in Depressive Disorder and Generalized Epilepsy, sponsored by Mayo Clinic. Withdrawn at 1 site in United States. Open to participants aged 10 Years to 21 Years. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Also known as: Soterix Medical Model 1300A
Children's Depression Rating Scale - Revised (CDRS-R) total score
clinician-rated continuous measure of depression severity based on participant and parent interviews
Time frame: 2 weeks
Children's Depression Rating Scale - Revised (CDRS-R) total score
clinician-rated continuous measure of depression severity based on participant and parent interviews
Time frame: 3 months, 6 months
Quick Inventory of Depressive Symptoms - Adolescent - Self-Report (QIDS-A17-SR) total score
participant-reported continuous measure of depression severity
Time frame: day 1, day 5, day 10, 3 months, 6 months
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
Time frame: days 1-10, 2 weeks, 3 months, 6 months
Columbia Suicide Severity Rating Scale (C-SSRS)
measure of suicidal ideation and behavior based on clinician interview
Time frame: day 1, day 5, day 10, 2 weeks, 3 months, 6 months
Young Mania Rating Scale (YMRS)
measure of manic symptoms based on clinician interview/observation
Time frame: day 5, 2 weeks
Affective Reactivity Index (ARI)
parent- and participant-report questionnaires regarding symptoms of irritability
Time frame: 2 weeks, 3 months, 6 months
Mayo Seizure Frequency Assessment
parent- and participant-report questionnaires regarding seizure frequency
Time frame: 2 weeks, 3 months, 6 months
Liverpool Seizure Severity Scale (1998 revision)
parent-/participant-report questionnaire regarding seizure severity and quality
Time frame: 2 weeks, 3 months, 6 months
Impact of Pediatric Epilepsy Scale (IPES)
parent-report questionnaire regarding impact of epilepsy of quality of life
Time frame: 2 weeks, 3 months, 6 months
Quality of Life in Epilepsy Inventory for Adolescents (QOLIE-AD-48)
participant-report questionnaire regarding impact of epilepsy of quality of life
Time frame: 2 weeks, 3 months, 6 months
NIH Toolbox® for Assessment of Neurological and Behavioral Function
validated and age-normed computer-administered battery of measures assessing cognitive functioning
Time frame: 2 weeks
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
Time frame: 2 weeks
This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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