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Neurostimulation
Safety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar Depression
N/A
Waitlist Available
Led By Yechiel Levkovitz, MD
Research Sponsored by Brainsway
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial will test if a new brain stimulation treatment is effective and safe for people with bipolar depression who have not responded to other medications.
Eligible Conditions
- Depression, Bipolar Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Deep TMS TreatmentActive Control1 Intervention
Deep TMS treatment is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The H-coil is a novel DTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions.
Group II: Sham TreatmentPlacebo Group1 Intervention
In the sham treatment,the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the brain.
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Who is running the clinical trial?
BrainswayLead Sponsor
37 Previous Clinical Trials
2,632 Total Patients Enrolled
Yechiel Levkovitz, MDPrincipal InvestigatorShalvata Mental Health Center
1 Previous Clinical Trials
100 Total Patients Enrolled