NCT01718730

Cortical Excitability and Inhibition in MDD

Cortical Excitability and Inhibition in Children and Adolescents With Major Depressive Disorder

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 13 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn if measures of brain activity are different in children and adolescents with depression who are in different stages of treatment. This is important because it may identify a biological marker for depression that could one day be used to identify depressed children who would benefit from certain treatments (medications for example), or to monitor how well treatments are working. Brain activity measures(known as cortical excitability and inhibition) will be collected by Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive (no surgery or implants) brain stimulation technology which can make parts of the brain work without putting any wires or chemicals into the body. Measurements will take place over one 3-hour visit. This study does not provide any form of treatment. \*There is an optional portion of the study that uses a brain scan to gather measures of brain structure and brain chemicals. The brain scan is called magnetic resonance and spectroscopy (MRI/MRS). MRI/MRS uses magnetic fields to study the structure of the brain and brain chemicals. The PI will determine eligibility for the MRI/MRS portion of the study.

Detailed description

This study is focused on understanding the neurophysiology of major depressive disorder (MDD), and the impact of selective serotonin reuptake inhibitors (SSRIs) in children and adolescents. This is a cross-sectional study which will utilize single and paired-pulse transcranial magnetic stimulation (TMS) to collect measures of glutamatergic cortical excitability (the motor threshold and intracortical facilitation), and GABAergic cortical inhibition (the cortical silent period and intracortical inhibition) of the motor cortex in chilren and adolescents in various disease states of MDD. The optional proton magnetic resonance spectroscopy and imaging scans (MRS/MRI) at 3 Tesla (3T) will examine glutamate concentrations in the motor cortex and anterior cingulate cortex. This is a biomarker study (MRI/MRS and TMS neurophysiology measures); treatment is not provided in any form. This study will not utilize Repetitive Transcranial Magnetic Stimulation (rTMS).

Conditions

• Major Depressive Disorder, Recurrent, Mild
• Depressive Disorder, Major

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Stimulation (TMS)	Single and paired-pulse TMS applied to the motor cortex will collect measures of cortical excitability and inhibition.
DEVICE	Magnetic Resonance Spectroscopy and Imaging	MRS/MRI Scans will examine glutamate concentrations in the motor cortex and anterior cingulate cortex.

Timeline

• Start date: 2012-10-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2012-10-31
• Last updated: 2019-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study