Transcranial Direct Current Stimulation (tDCS) in Children and Adolescents With Epilepsy and Depression
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Paul Croarkin, D.O., M.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available