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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)

This study is not yet open for participant recruitment.
Verified December 2011 by Shalvata Mental Health Center
Sponsor:
Collaborator:
Brainsway-moach Ltd.
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01501825
First received: December 27, 2011
Last updated: July 3, 2012
Last verified: December 2011
History of Changes
  Purpose

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.

Condition Intervention
Depression
 Device: 5 channels Multiway deep Transcranial Magnetic Stimulator
Device: five channels Multiway deep Transcranial Magnetic Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • Clinical antidepressant response [ Time Frame: day 20 ] [ Designated as safety issue: No ]
    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%.


Secondary Outcome Measures:
  • Clinical antidepressant remission [ Time Frame: day 20 ] [ Designated as safety issue: No ]
    Clinical antidepressant remission at the end of the treatment, define as exit HDRS-21 <10.

  • Symptomatic improvement [ Time Frame: day 20 ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  1. 10 Hz over the left PFC.
  2. 1 Hz over the right PFC.
  3. 10 Hz over the left parietal cortex.
  4. 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)

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501825

Contacts
Contact: yechiel Levkovitz, MD, Phd 097478644 ylevk@clalit.org.il

Locations
Israel
shalvata MHC
Hod HAsharon, Israel
Shalvata Mental Health Center Not yet recruiting
Hod-HaSharon, Israel
Contact: Yechiel Levkovitz, MD,Phd     972-9-7478644     ylevk@clalit.org.il    
Principal Investigator: Yechiel Levkovitz, MD, Phd            
Sponsors and Collaborators
Shalvata Mental Health Center
Brainsway-moach Ltd.
Investigators
Principal Investigator: Yechiel Levkovitz, MD, Phd Shalvata Medical Health Center
  More Information

No publications provided

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01501825     History of Changes
Other Study ID Numbers: sha-16-11
Study First Received: December 27, 2011
Last Updated: July 3, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013