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Deep Transcranial Magnetic Stimulation

Deep TMS for Depression

N/A
Recruiting
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 week
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a device that uses magnetic pulses to stimulate the brain. It aims to help people with Major Depressive Disorder who have depressive episodes. The study will check if this new method is as safe and effective as current treatments. Magnetic seizure therapy (MST) is a potential alternative to electroconvulsive therapy (ECT) that may not adversely affect memory.

Who is the study for?
This trial is for individuals with Major Depressive Disorder (MDD) who are experiencing a depressive episode. The specific details about eligibility criteria were not provided, so it's important to contact the study organizers for more information on who can participate.
What is being tested?
The trial is testing an accelerated form of Theta Burst Stimulation using the Brainsway Deep TMS System. It aims to show that this new treatment method works as well as the current standard High Frequency stimulation protocol in treating MDD.
What are the potential side effects?
While side effects were not detailed, common ones from similar TMS treatments include headache, scalp discomfort at the site of stimulation, tingling or spasms of facial muscles.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Hamilton Depression Rating Scale (HDRS)-21 score in the investigational group
Secondary study objectives
Change in Clinical Global Impression Improvement (CGI-I) scores in the investigational group
Change in Clinical Global Impression-Severity (CGI-S) scores in the investigational group
Remission rate in the investigational group
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Investigational stimulation groupExperimental Treatment1 Intervention
The experimental group will receive the new investigational deep TMS protocol
Group II: Standard-of-care stimulation groupActive Control1 Intervention
The control group will receive the currently FDA-cleared standard-of-care deep TMS protocol.

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Who is running the clinical trial?

BrainswayLead Sponsor
37 Previous Clinical Trials
2,648 Total Patients Enrolled
14 Trials studying Depression
1,465 Patients Enrolled for Depression
~13 spots leftby Dec 2024
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