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)

NCT01501825 | Unknown DMC

• 1 other identifier: sha-16-11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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):

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

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical antidepressant remission

  day 20

• Symptomatic improvement

  day 20

Study Arms (2)

single channel

ACTIVE COMPARATOR

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

Device: 5 channels Multiway deep Transcranial Magnetic Stimulator

four channels

EXPERIMENTAL

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

Interventions

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)

single channel

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)

four channels

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shalvata Mental Health Center: lead
• Brainsway-moach Ltd.: collaborator

Study Sites (2)

Shalvata Mental Health Center

Hod HaSharon, Israel

Location

shalvata MHC

Hod HaSharon, Israel

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Yechiel Levkovitz, MD, Phd

  Shalvata Medical Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yechiel Levkovitz, MD, Phd

CONTACT

097478644; ylevk@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2011
• First Posted: December 29, 2011
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 4, 2012

Record last verified: 2011-12

Locations

IL (2)