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)

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):

1. Single Channel with a coil placed over the left PFC (10 Hz).
2. 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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Device: 5 channels Multiway deep Transcranial Magnetic Stimulator; Device: five channels Multiway deep Transcranial Magnetic Stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yechiel Levkovitz, MD, Phd; Phone Number: 097478644; Email: ylevk@clalit.org.il

Study Locations

• Israel
  • Hod HAsharon, Israel
    • Shalvata MHC
  • Hod-HaSharon, Israel
    • Shalvata Mental health Center
    • Contact: Yechiel Levkovitz, MD,Phd; Phone Number: 972-9-7478644; Email: ylevk@clalit.org.il
    • Principal Investigator: yechiel levkovitz, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Outpatient
• Diagnosed by senior psychiatrist as suffering from major depression episode according to DSM IV using the Structured Clinical Interview for DSM-4 (SCID).
• Rating on HDRS-21>20.
• Age: 18-68 years.
• Treated for the current depressive episode, at least four weeks, with at least one antidepressant in accepted dose, without improvement, according to their medical chart and ATHF ( antidepressant treatment history form) instruction guidelines .
• Gave informed consent for participation in the study.
• Negative answers on safety screening questionnaire for transcranial magnetic stimulation.

Exclusion Criteria:

• Diagnosis as suffering from other diagnosis on axis 1 ( like: schizophrenia, bipolar disorder, psychotic depression, geriatric depression).
• Diagnosis as suffering from Severe Borderline Personality Disorder or hospitalized due to exacerbation related to of borderline personality disorder.
• Substantial suicidal risk as judged by the treating psychiatrist.
• Attempted suicide in the past year.
• Any current unstable medical or surgical illness.
• History of seizure or heat convulsion.
• History of epilepsy or seizure in first degree relatives.
• History of head injury.
• History of any metal in the head (outside the mouth).
• Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips, cochlear implants or any medical pumps.
• History of hearing loss.
• History of drug abuse or alcoholism in the last 6 month.
• Pregnancy or not using a reliable method of birth control.
• Systematic and metabolic unstable disorders.
• Inadequate communication with the patient.
• Under custodial care.
• Participation in current clinical study or clinical study within 30 days prior to this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Four channels: 10 Hz over the left PFC.; 1 Hz over the right PFC.; 10 Hz over the left parietal cortex.; 1 Hz over the right parietal cortex.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	day 20

Collaborators and Investigators

• Sponsor: Shalvata Mental Health Center
• Collaborators: Brainsway-moach Ltd.
• Investigators: Principal Investigator: Yechiel Levkovitz, MD, PhD, Shalvata Medical Health Center

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: December 27, 2011
• First Submitted That Met QC Criteria: December 28, 2011
• First Posted (Estimate): December 29, 2011

Study Record Updates

• Last Update Posted (Estimate): July 4, 2012
• Last Update Submitted That Met QC Criteria: July 3, 2012
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: sha-16-11