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Brain Stimulation

Theta Burst Stimulation for Bipolar Disorder

N/A

Recruiting

Led By Fabio Ferrarelli, MD, PhD

Research Sponsored by Mary Phillips, MD MD (Cantab)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No family history of BD

Not in a current depressive episode

Must not have

<18 years of age or >35 year of age

In current depressive episode

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in magnitude immediately before and immediately after each ctbs condition at scan visits (30-60 mins)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of transcranial brain stimulation on brain activity and emotions in adults with and without bipolar disorder, in order to better understand the predisposing brain mechanisms of bipolar disorder.

Who is the study for?

This trial is for adults aged 18-35 with Bipolar Disorder I/II in remission or mild-moderate hypomania. They must score low on depression and mania scales, can be unmedicated or on certain stable medications (excluding antidepressant monotherapy), and have no severe psychiatric disorders, substance abuse issues, head injuries, neurological diseases, or family history of epilepsy.

What is being tested?

The study tests the effects of Theta Burst Stimulation (TBS) on brain activity and emotions in people with Bipolar Disorder. It compares Continuous TBS (cTBS), which is an active treatment, to a sham version that mimics the procedure without real stimulation to see if cTBS reduces symptoms like negative emotions.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of TBS may include headache, scalp discomfort at the stimulation site during treatment sessions, lightheadedness immediately following treatment sessions, and rare risk of seizure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My family does not have a history of bipolar disorder.

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I am not currently experiencing a depressive episode.

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I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am either younger than 18 or older than 35.

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I am currently experiencing a depressive episode.

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My diagnosis is not bipolar I or II disorder.

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I am not taking SNRI antidepressants or bupropion.

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I am not taking any psychotropic medications not allowed in the study.

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I have been diagnosed with depression and scored 8 or higher on a depression scale.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in magnitude immediately before and immediately after each ctbs condition at scan visits (30-60 mins)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in magnitude immediately before and immediately after each ctbs condition at scan visits (30-60 mins)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in magnitude immediately before and immediately after each ctbs condition at scan visits (30-60 mins) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reward expectancy-related left amygdala activity

Reward expectancy-related left orbitofrontal cortex activity

Reward expectancy-related left ventral striatum activity

+16 more

Secondary study objectives

Left amygdala activity

Left orbitofrontal cortex activity

Left ventral lateral prefrontal cortex-wholebrain functional connectivity

+13 more

Other study objectives

Left ventrolateral prefrontal cortex-left amygdala resting state functional connectivity

Left ventrolateral prefrontal cortex-left orbitofrontal cortex resting state functional connectivity

Left ventrolateral prefrontal cortex-left ventral striatum resting state functional connectivity

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Left vlPFC/Left vlPFC sham/Left SSExperimental Treatment2 Interventions

A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned: * left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex) * left SS cTBS (cTBS applied to the left somatosensory area) * left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.

Group II: Left vlPFC sham/Left vlPFC/Left SSExperimental Treatment2 Interventions

Group III: Left vlPFC sham/Left SS/Left vlPFCExperimental Treatment2 Interventions

Group IV: Left ventrolateral prefrontal cortex (vlPFC)/Left SS/Left vlPFC shamExperimental Treatment2 Interventions

Group V: Left SS/Left vlPFC/Left vlPFC shamExperimental Treatment2 Interventions

Group VI: Left SS/Left vlPFC sham/Left vlPFCExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous Theta Burst Stimulation (cTBS)

2020

N/A