A Prospective, Comparative Study to Explore the Efficacy and Safety of the Five Channels Multiway Deep Transcranial Magnetic Stimulation (TMS) Device in Subjects With Major Depression Disorder (MDD)
|ClinicalTrials.gov Identifier: NCT01501825|
Recruitment Status : Unknown
Verified December 2011 by Shalvata Mental Health Center.
Recruitment status was: Not yet recruiting
First Posted : December 29, 2011
Last Update Posted : July 4, 2012
The Multiway stimulator 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 includes five channels which can operate up to five independent TMS coils, either simultaneously or sequentially.
The Multiway device 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.
The purpose of the study is to explore the efficacy and safety of Multiway deep TMS in comparison to a single channel DTMS treatment in subjects with MDD.
Subjects will be treated with one of two designs of the study device (the Multiway Coil TMS Device):
- Single Channel with a coil placed over the left PFC (10 Hz).
- Four channels: a. 10 Hz over the left PFC. b. 1 Hz over the right PFC. c. 10 Hz over the left parietal cortex. d. 1 Hz over the right parietal cortex.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Device: 5 channels Multiway deep Transcranial Magnetic Stimulator Device: five channels Multiway deep Transcranial Magnetic Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2013|
Active Comparator: single channel
Single Channel with a coil placed over the left PFC (10 Hz).
Device: 5 channels Multiway deep Transcranial Magnetic Stimulator
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)
Experimental: four channels
Device: five channels Multiway deep Transcranial Magnetic Stimulation
During the four channels treatment trial period the patients will receive the following dose of rTMS: 10 Hz- left DLPFC, 1Hz - right DLPFC together, and than 10 Hz- left parietal cortex, 1Hz - right parietal cortex 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)
- Clinical antidepressant response [ Time Frame: day 20 ]Clinical antidepressant response at the end of the treatment, defined as a decline in Hamilton depression rating scale (HDRS-21) from the baseline rating by 50%.
- Clinical antidepressant remission [ Time Frame: day 20 ]Clinical antidepressant remission at the end of the treatment, define as exit HDRS-21 <10.
- Symptomatic improvement [ Time Frame: day 20 ]Symptomatic improvement at the 4-week end point as measured with Hamilton Anxiety Rating Scale ( HARS), Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) , Clinical Global Impression (CGI), Cognitive improvement measured by a computerized battery of tests (CANTAB).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501825
|Contact: yechiel Levkovitz, MD, Phdfirstname.lastname@example.org|
|Hod HAsharon, Israel|
|Shalvata Mental Health Center||Not yet recruiting|
|Contact: Yechiel Levkovitz, MD,Phd 972-9-7478644 email@example.com|
|Principal Investigator: Yechiel Levkovitz, MD, Phd|
|Principal Investigator:||Yechiel Levkovitz, MD, Phd||Shalvata Medical Health Center|