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Deep Transcranial Magnetic Stimulation

Investigational stimulation group for Depression

N/A

Waitlist Available

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

Study Summary

This trial aims to test a new treatment device called BrainsWay Deep Transcranial Magnetic Stimulation for Major Depressive Disorder. The study will compare the safety and effectiveness of this device to the current

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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 week

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Hamilton Depression Rating Scale (HDRS)-21 score in the investigational group

Secondary outcome measures

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

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.

Do I qualify?Apply below to find out

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to participate in this research study?

"Participants must be diagnosed with depression and fall within the age range of 22 to 68 years old in order to meet eligibility criteria for this trial, which aims to enroll approximately 104 individuals."

Answered by AI

At present, how many locations are hosting this particular clinical trial?

"Five sites are currently enrolling participants for this clinical trial, such as Complete Mind Care of PA in Abington, Fermata Health in Brooklyn, and Novus Neurology in Tuscaloosa. Additionally, there are five more locations where enrollment is taking place."

Answered by AI

Does this study allow participation for individuals older than 20 years of age?

"Patients eligible for participation in this research endeavor must fall within the age range of 22 to 68 years. Notably, there are a total of 116 investigations geared towards individuals younger than 18 and 650 studies focused on those older than 65."

Answered by AI

Are there any available openings for patients to participate in this medical study?

"As per the details available on clinicaltrials.gov, at present, this particular clinical trial is not in need of participants. Originally posted on April 15th, 2024 and last updated on April 5th, 2024. Although recruitment for this study has concluded, there are currently a total of 888 other active trials seeking participants."

Answered by AI