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):
- 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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Hod HAsharon, Izrael
- Shalvata MHC
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Hod-HaSharon, Izrael
- Shalvata Mental Health Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: single channel
Single Channel with a coil placed over the left PFC (10 Hz).
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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)
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Experimentální: four channels
Four channels:
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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) |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Clinical antidepressant response
Časové okno: day 20
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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%.
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day 20
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Clinical antidepressant remission
Časové okno: day 20
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Clinical antidepressant remission at the end of the treatment, define as exit HDRS-21 <10.
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day 20
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Symptomatic improvement
Časové okno: day 20
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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).
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day 20
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Yechiel Levkovitz, MD, PhD, Shalvata Medical Health Center
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- sha-16-11
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