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Transcranial Magnetic Stimulation
iTBS in Bipolar I Depression
N/A
Waitlist Available
Led By Peter Zandi, PhD
Research Sponsored by Johns Hopkins University
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 baseline and post treatment up to 5 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will study a new type of brain stimulation to see if it's safe and effective for treating mental health issues.
Eligible Conditions
- Bipolar Disorder
- Depression, Bipolar Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and post treatment up to 5 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post treatment up to 5 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Open label study, all participants will receive novel iTBS
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnus Transcranial Magnetic Neuromodulation System (MNS) with SAINT®(Stanford Accelerated Intelligent Neuromodulation Therapy)
2023
N/A
~10
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Who is running the clinical trial?
Baszucki Brain Research FundOTHER
7 Previous Clinical Trials
323 Total Patients Enrolled
Magnus MedicalIndustry Sponsor
4 Previous Clinical Trials
1,240 Total Patients Enrolled
University of Texas at AustinOTHER
378 Previous Clinical Trials
86,599 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,621 Total Patients Enrolled
Peter Zandi, PhDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
1,650 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently experiencing a mix of manic and depressive symptoms, as determined by your doctor using specific criteria.You have a history of epilepsy, metal in your head or skull, heart problems, Obsessive Compulsive Disorder (OCD), or autism spectrum disorder.You have received electroconvulsive therapy (ECT) within the last 3 months.You have been diagnosed with Bipolar I disorder according to a book called the DSM-5.You have a serious health condition that is not stable or under control.You have a serious neurological disorder, such as seizures or a history of severe head injury that caused loss of consciousness for more than 10 minutes, or evidence of brain injury.You have a condition that the investigator believes could make it difficult for you to complete the study, such as a significant physical disability that affects your ability to perform memory tasks or neuropsychological tests.The doctor thinks you are currently at risk of hurting yourself.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.