Intensive TMS for Bipolar Disorder

Recruiting in Palo Alto (17 mi)

Overseen byYvette Sheline, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Trial Summary

What is the purpose of this trial?

The research study is being conducted to test whether using high dose spaced theta-burst rTMS (a form of transcranial magnetic stimulation) produces a significant reduction in depressive symptoms compared with sham. This project will recruit patients aged 18-70 with symptoms of bipolar depression who have failed (or not shown signs of improvement) after at least two prior treatments.

Eligibility Criteria

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.

Inclusion Criteria

You have been diagnosed with bipolar depression according to the DSM 5 criteria.

Able to provide informed consent to participate in the study

Depression severity as represented by scoring at least 20 on Montgomery-Asberg Depression Rating Scale (MADRS)

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Exclusion Criteria

You have any implants, medical conditions, or reasons that would make it unsafe for you to have TMS or MRI.

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.

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Treatment Details

Interventions

Intensive intermittent theta-burst stimulation (iTBS) (Transcranial Magnetic Stimulation)

Trial OverviewThe 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.

Participant Groups

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.