NCT02222012

Neuromarkers Identification in Major Depressive Disorder Based on Monitoring Measures

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shalvata Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Depression

Interventions

Type	Name	Description
DEVICE	single channel "Multiway Coil®"	During the single channel treatment trial period the patients will receive the following dose of rTMS: 10 Hz - left DLPFC ( 10 Hz, at 120% MT, 3 sec pulse train, 20 second inter-train interval, 55 trains, i.e. a total of 1650 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 33,000pulses in 4 weeks).
DEVICE	Two channels "Multiway stimulator coil®" (Brainsway Ltd.)	During the two channels treatment trial period the patients will receive the following dose of rTMS: 10 Hz- left DLPFC, 1Hz - right DLPFC together. 10 Hz protocol: ( 10 Hz, at 120% MT, 3 sec pulse train, 20 second inter-train interval, 55 trains, i.e. a total of 1650 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 33,000pulses in 4 weeks) 1 Hz protocol: 1 Hz, at 120% MT, 5 min pulse train, 1 min inter-train interval, 6 trains, i.e. a total of 1800 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 36,000 pulses in 4 weeks).

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-09-01
• Completion: 2017-09-01
• First posted: 2014-08-21
• Last updated: 2014-08-21

Locations

1 site across 1 country: Israel