Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Brainsway-moach Ltd. | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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):
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single channel | Active Comparator | Single Channel with a coil placed over the left PFC (10 Hz). |
|
| four channels | Experimental | Four channels:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5 channels Multiway deep Transcranial Magnetic Stimulator | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical antidepressant response | 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%. | day 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical antidepressant remission | Clinical antidepressant remission at the end of the treatment, define as exit HDRS-21 <10. | day 20 |
| Symptomatic improvement | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yechiel Levkovitz, MD, Phd | Contact | 097478644 | ylevk@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Yechiel Levkovitz, MD, Phd | Shalvata Medical Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shalvata Mental Health Center | Hod HaSharon | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| five channels Multiway deep Transcranial Magnetic Stimulation | Device | 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) |
|
| day 20 |
| shalvata MHC | Hod HaSharon | Israel |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided