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)

Shalvata Mental Health Center

Status: Unknown

Conditions: Depression

Treatments: Device: five channels Multiway deep Transcranial Magnetic Stimulation; Device: 5 channels Multiway deep Transcranial Magnetic Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT01501825

sha-16-11

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 67 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

single channel

Active Comparator group

Description:

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

Treatment:

Device: 5 channels Multiway deep Transcranial Magnetic Stimulator

four channels

Experimental group

Description:

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.

Treatment:

Device: five channels Multiway deep Transcranial Magnetic Stimulation