Deep TMS Treatment for Depression, Bipolar Disorder

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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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