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

Withdrawn before enrolling · Not applicable

Conditions studied: Depressive Disorder, Generalized Epilepsy

In brief

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.

Key facts

Study ID

NCT03368469

Run by

Mayo Clinic

People needed

0

Starts

2018-02-23

Expected to finish

2019-01-01

Last updated by the study team

2020-01-18

Who can join

Age: 10 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

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
• 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

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.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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