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

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-001007
    NCT ID: NCT03368469
    Sponsor Protocol Number: 17-001007

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Paul Croarkin, D.O., M.S.

Open for enrollment

Contact information:

Marjorie Gresbrink

(507)255-0624

Gresbrink.Marjorie@mayo.edu

More information

Publications

Adolescent depression is a prevalent disorder with substantial morbidity and mortality. Current treatment interventions do not target relevant pathophysiology and are frequently ineffective, thereby leading to a substantial burden for individuals, families, and society. During adolescence, the prefrontal cortex undergoes extensive structural and functional changes. Recent work suggests that frontolimbic development in depressed adolescents is delayed or aberrant. The judicious application of non-invasive brain stimulation techniques to the prefrontal cortex may present a promising opportunity for durable interventions in adolescent depression. Transcranial direct current stimulation (tDCS) applies a low-intensity, continuous current that alters cortical excitability. While this modality does not elicit action potentials, it is thought to manipulate neuronal activity and neuroplasticity. Specifically, tDCS may modulate -methyl-d-aspartate receptors and L-type voltage-gated calcium channels and effect changes through long-term potentiation or long-term depression-like mechanisms. This mini-review considers the neurobiological rationale for developing tDCS protocols in adolescent depression, reviews existing work in adult mood disorders, surveys the existing tDCS literature in adolescent populations, reviews safety studies, and discusses distinct ethical considerations in work with adolescents. Read More on PubMed
Promising results in adult neurologic and psychiatric disorders are driving active research into transcranial brain stimulation techniques, particularly transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), in childhood and adolescent syndromes. TMS has realistic utility as an experimental tool tested in a range of pediatric neuropathologies such as perinatal stroke, depression, Tourette syndrome, and autism spectrum disorder (ASD). tDCS has also been tested as a treatment for a number of pediatric neurologic conditions, including ASD, attention-deficit/hyperactivity disorder, epilepsy, and cerebral palsy. Here, we complement recent reviews with an update of published TMS and tDCS results in children, and discuss developmental neuroscience considerations that should inform pediatric transcranial stimulation. Read More on PubMed
Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that consists of applying a weak electric current over the scalp to modulate cortical excitability. tDCS has been extensively investigated in adults with psychiatric disorders. The aim of this study was to review the current literature regarding the use of tDCS in children and adolescents with psychiatric disorders. Read More on PubMed
Noninvasive brain stimulation (NIBS) techniques such as transcranial magnetic stimulation (TMS) and transcranial current stimulation (tCS) have the potential to mitigate a variety of symptoms associated with neurological and psychiatric conditions, including stroke, cerebral palsy, autism, depression, and Tourette syndrome. While the safety of these modalities has been established in adults, there is a paucity of research assessing the safety of NIBS among children. Read More on PubMed

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20383786

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