Neuromarkers Identification in Major Depressive Disorder Based on Monitoring Measures

Depression Clinical Trial

Official title: Identification of Neuromarkers in Novel Neuromodulation Treatment in Major Depressive Disorder Based on Integration of Multiple Monitoring Measures

Status Not yet recruiting

Clinical Trial Summary

The investigators propose a multi-source pattern which integrates neuroimaging data associated with multiple, symptom-related neural processes relevant in depression to improve classification accuracy. The investigators conclude that combining brain activation related to the core-symptoms of depression using the multi-source monitoring data substantially increases classification accuracy while providing a sparse relational neuromarkers-model for future prediction.

Clinical Trial Description

The "Multiway stimulator coil®" (Brainsway Ltd.) is a novel TMS stimulator with several new and unique properties. Currently standard TMS devices include a single channel, and can operate only a single coil. The "Multiway stimulator coil®" (Brainsway Ltd.) includes two channels which can operate two independent TMS coils, either simultaneously or sequentially.

The "Multiway stimulator coil®" (Brainsway Ltd.) may be used to obtain a differential activation of various brain regions. For instance it can be used to induce high frequency stimulation of a certain brain region, thus inducing facilitation, while simultaneously stimulate at low frequency in another brain region, leading to inhibition.

In the current study the investigators propose a multi-source pattern which integrates neuroimaging data associated with multiple, symptom-related neural processes relevant in depression to improve classification accuracy. The investigators conclude that combining brain activation related to the core-symptoms of depression using the multi-source monitoring data substantially increases classification accuracy while providing a sparse relational neuromarkers-model for future prediction.

The purpose of the study is to to monitor and optimize the anti depressive effect of brain modulation technique using novel multi model monitoring approach.

Subjects will be treated with one of two designs of the study device (the "Multiway Coil®"):

1. Single Channel with a coil placed over the left PFC (10 Hz).

2. Two channels: a. 10 Hz over the left PFC. b. 1 Hz over the right PFC.

All subjects in the current study will undergo monitoring procedure inclusive of functional MRI and electroencephalogram. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

• NCT number: NCT02222012
• Study type: Interventional
• Source: Shalvata Mental Health Center
• Contact: Yuval Bloch, MD, Phd
• Phone: 097478644
• Email: yuvalbl@clalit.org.il
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2014
• Completion date: September 2017