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Depressive DisorderNCT03368469

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

A study testing transcranial direct current stimulation in people with Depressive Disorder and Generalized Epilepsy, run by Mayo Clinic at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 10 to 21 years
Conditions the study is for
Depressive Disorder, Generalized Epilepsy
What is being tested?
transcranial direct current stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
23 Feb 2018to Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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.

Read the 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.

Keywords
Transcranial, Stimulation
Medical subject headings
Depressive Disorder, Epilepsy, Generalized

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcranial direct current stimulationDevice

    Also called Soterix Medical Model 1300A

    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.

Study groups in NCT03368469
Study groupRoleWhat they receive
transcranial direct current stimulationExperimentalTranscranial 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)
Receives: Device: transcranial direct current stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 2 weeks

Secondary outcomes (12)

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

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

    Measured: 3 months, 6 months

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

    participant-reported continuous measure of depression severity

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

  3. 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

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

  4. Columbia Suicide Severity Rating Scale (C-SSRS)

    measure of suicidal ideation and behavior based on clinician interview

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

  5. Young Mania Rating Scale (YMRS)

    measure of manic symptoms based on clinician interview/observation

    Measured: day 5, 2 weeks

  6. Affective Reactivity Index (ARI)

    parent- and participant-report questionnaires regarding symptoms of irritability

    Measured: 2 weeks, 3 months, 6 months

  7. Mayo Seizure Frequency Assessment

    parent- and participant-report questionnaires regarding seizure frequency

    Measured: 2 weeks, 3 months, 6 months

  8. Liverpool Seizure Severity Scale (1998 revision)

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

    Measured: 2 weeks, 3 months, 6 months

  9. Impact of Pediatric Epilepsy Scale (IPES)

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

    Measured: 2 weeks, 3 months, 6 months

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

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

    Measured: 2 weeks, 3 months, 6 months

  11. NIH Toolbox® for Assessment of Neurological and Behavioral Function

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

    Measured: 2 weeks

  12. 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

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2017
  2. Study start23 Feb 2018
  3. Primary completionJan 2019 (estimated)
  4. Study completionJan 2019 (estimated)

Why it stopped: The study team was unable to recruit and enroll subjects. The study is now closed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03368469
Sponsor's protocol ID
17-001007
Status last verified
Jan 2020
First submitted
1 Dec 2017
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 28638351

  • 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.

    PubMed 28229395

  • 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.

    PubMed 27027666

  • 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.

    PubMed 28751225

  • 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.

    PubMed 25499471

Questions about this trial

What is this clinical trial studying?

A study testing transcranial direct current stimulation in people with Depressive Disorder and Generalized Epilepsy, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Children's Depression Rating Scale - Revised (CDRS-R) total score (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03368469, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.

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