Examining the Effect of EEG-guided Theta Burst Stimulation in Bipolar Disorder

Recruiting in Palo Alto (17 mi)

Overseen by Mary L Phillips, MD, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mary Phillips, MD MD (Cantab)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses a special type of brain stimulation guided by brain activity measurements to help adults with bipolar disorder. The goal is to balance brain activity by calming overactive areas and stimulating underactive areas, which may help manage mood and behavior.

Eligibility Criteria

Inclusion Criteria

18-35 years of age

Provides the contact information of a medical provider (including but not limited to a PCP) that we may communicate with for any concerns of escalating symptoms of mania

You do not have any mental health conditions that cause hallucinations or delusions.

Exclusion Criteria

You have a history of head injury, neurological conditions like autism, or other medical conditions that require ongoing treatment.

You have taken certain medications in the past month that can increase the risk of seizures.

You have been diagnosed with bipolar disorder and are currently experiencing symptoms of depression or are in a state of partial remission or euthymia, which means your symptoms are not fully resolved for at least 2 months.

Treatment Details

Interventions

• Continuous Theta Burst Stimulation (cTBS) (Non-invasive Brain Stimulation)
• Intermittent Theta Burst Stimulation (iTBS) (Non-invasive Brain Stimulation)

Participant Groups

Group I: right dlPFC iTBS/left Som cTBS/Left vLPFC cTBS Experimental Treatment 2 Interventions

A random number sequence will be generated for randomization of the 3 EEG/TBS session order to which each participant is assigned: right dlPFC iTBS (iTBS applied to the right dorsolateral prefrontal cortex) left Som cTBS (cTBS applied to the left somatosensory cortex) left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)

Group II: right dlPFC iTBS/Left vLPFC cTBS/left Som cTBS Experimental Treatment 2 Interventions

A random number sequence will be generated for randomization of the 3 EEG/TBS session order to which each participant is assigned: right dlPFC iTBS (iTBS applied to the right dorsolateral prefrontal cortex) left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex) left Som cTBS (cTBS applied to the left somatosensory cortex)

Group III: left Som cTBS/right dlPFC iTBS/Left vLPFC cTBS Experimental Treatment 2 Interventions

A random number sequence will be generated for randomization of the 3 EEG/TBS session order to which each participant is assigned: left Som cTBS (cTBS applied to the left somatosensory cortex) right dlPFC iTBS (iTBS applied to the right dorsolateral prefrontal cortex) left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)

Group IV: left Som cTBS/Left vLPFC cTBS/right dlPFC iTBS Experimental Treatment 2 Interventions

A random number sequence will be generated for randomization of the 3 EEG/TBS session order to which each participant is assigned: left Som cTBS (cTBS applied to the left somatosensory cortex) left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex) right dlPFC iTBS (iTBS applied to the right dorsolateral prefrontal cortex)

Group V: Left vLPFC cTBS/right dlPFC iTBS/left Som cTBS Experimental Treatment 2 Interventions

A random number sequence will be generated for randomization of the 3 EEG/TBS session order to which each participant is assigned: left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex) right dlPFC iTBS (iTBS applied to the right dorsolateral prefrontal cortex) left Som cTBS (cTBS applied to the left somatosensory cortex)

Group VI: Left vLPFC cTBS/left Som cTBS/right dlPFC iTBS Experimental Treatment 2 Interventions

A random number sequence will be generated for randomization of the 3 EEG/TBS session order to which each participant is assigned: left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex) left Som cTBS (cTBS applied to the left somatosensory cortex) right dlPFC iTBS (iTBS applied to the right dorsolateral prefrontal cortex)

Continuous Theta Burst Stimulation (cTBS) is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Transcranial Magnetic Stimulation (TMS) for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)

🇪🇺 Approved in European Union as Transcranial Magnetic Stimulation (TMS) for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)

🇨🇦 Approved in Canada as Transcranial Magnetic Stimulation (TMS) for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Pittsburgh Pittsburgh, PA

Who Is Running the Clinical Trial?

Mary Phillips, MD MD (Cantab) Lead Sponsor

Milken Institute Collaborator

References