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Transcranial Magnetic Stimulation
Intensive TMS for Bipolar Disorder
N/A
Waitlist Available
Led By Yvette Sheline, MD
Research Sponsored by University of Pennsylvania
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 upon study completion, approximately 1 week
Awards & highlights
Study Summary
This trial will test if high-dose, spaced out theta-burst transcranial magnetic stimulation (rTMS) can help reduce symptoms of bipolar depression better than a sham treatment. It will enroll patients who are 18-70 years old, have failed two prior treatments, and still have depressive symptoms.
Who is the study for?
This trial is for adults aged 18-70 with bipolar depression who haven't improved after at least two treatments. Participants must score ≥20 on the MADRS, be right or left-handed, able to consent, and on a stable medication regimen including one mood stabilizer. Exclusions include those with certain implants, psychotic disorders, rapid cycling Bipolar illness, major neurological disorders or medical illnesses like advanced cancer.Check my eligibility
What is being tested?
The study tests if high dose spaced theta-burst rTMS can significantly reduce depressive symptoms in bipolar depression compared to sham treatment. It targets patients who have not responded well to previous therapies and aims to determine the effectiveness of this intensive TMS approach.See study design
What are the potential side effects?
While specific side effects are not listed here, TMS generally may cause discomfort at the stimulation site, headache, lightheadedness or seizures in rare cases. The intensity of these side effects could vary based on individual response to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ upon study completion, approximately 1 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon study completion, approximately 1 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical efficacy of high dose spaced theta burst (HDS-TBS)
Secondary outcome measures
Relationship between change in brain resting state functional connectivity and treatment effects
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active Transcranial Magnetic StimulationActive Control1 Intervention
Active Intensive iTBS involves intermittent theta-burst stimulation (iTBS), a patterned form of repetitive transcranial magnetic stimulation (rTMS) over the left dorsal lateral prefrontal cortex (L-DLPFC).
Group II: Sham Transcranial Magnetic StimulationPlacebo Group1 Intervention
Sham Intensive iTBS involves using the coil's electric stimulation functionality that allows for the delivery of a brief electric pulse to the scalp simultaneous to the TMS pulse, which mimics the scalp sensation from active stimulation.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,015 Previous Clinical Trials
42,873,992 Total Patients Enrolled
Yvette Sheline, MDPrincipal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
30 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have any implants, medical conditions, or reasons that would make it unsafe for you to have TMS or MRI.You have been diagnosed with bipolar depression according to the DSM 5 criteria.You have a mental illness that causes you to have hallucinations or delusions, or you currently experience these symptoms. However, if your psychiatrist believes that your personality disorder would not interfere with your ability to participate in the study, it may not be a reason for exclusion.If you have had more than 4 mood swings in the past year, you will not be able to participate in the study because you have a higher risk of experiencing manic episodes.You can be right-handed or left-handed.You do not have depression as your main health problem.You have depression that has not improved with at least two different antidepressant treatments, even when following specific guidelines for measuring improvement.
Research Study Groups:
This trial has the following groups:- Group 1: Active Transcranial Magnetic Stimulation
- Group 2: Sham Transcranial Magnetic Stimulation
Awards:
This trial has 0 awards, including: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.
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