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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)

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
5 channels Multiway deep Transcranial Magnetic Stimulator
five channels Multiway deep Transcranial Magnetic Stimulation
Sponsored by
Shalvata Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • shalvata MHC
  • Shalvata Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

single channel

four channels

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

Clinical antidepressant remission
Clinical antidepressant remission at the end of the treatment, define as exit HDRS-21 <10.
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).

Full Information

First Posted
December 27, 2011
Last Updated
July 3, 2012
Sponsor
Shalvata Mental Health Center
Collaborators
Brainsway-moach Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01501825
Brief Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shalvata Mental Health Center
Collaborators
Brainsway-moach Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single channel
Arm Type
Active Comparator
Arm Description
Single Channel with a coil placed over the left PFC (10 Hz).
Arm Title
four channels
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
5 channels Multiway deep Transcranial Magnetic Stimulator
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
five channels Multiway deep Transcranial Magnetic Stimulation
Intervention Description
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)
Primary Outcome Measure Information:
Title
Clinical antidepressant response
Description
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%.
Time Frame
day 20
Secondary Outcome Measure Information:
Title
Clinical antidepressant remission
Description
Clinical antidepressant remission at the end of the treatment, define as exit HDRS-21 <10.
Time Frame
day 20
Title
Symptomatic improvement
Description
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).
Time Frame
day 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yechiel Levkovitz, MD, Phd
Phone
097478644
Email
ylevk@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yechiel Levkovitz, MD, Phd
Organizational Affiliation
Shalvata Medical Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
shalvata MHC
City
Hod HAsharon
Country
Israel
Facility Name
Shalvata Mental Health Center
City
Hod-HaSharon
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yechiel Levkovitz, MD,Phd
Phone
972-9-7478644
Email
ylevk@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Yechiel Levkovitz, MD, Phd

12. IPD Sharing Statement

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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)

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