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Neurostimulation

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 6 weeks from baseline
Awards & highlights

Study 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 weeks
Treatment ~ Varies
Follow Up ~6 weeks from baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks from baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
HDRS-21 Score measured by change from baseline.
Secondary outcome measures
Clinical antidepressant remission rate at the 6-week visit

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.

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar Depression
2012. "Safety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01566591.
All > Transcranial Magnetic Stimulation
~9 spots leftby May 2025
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