Examining the Effect of EEG-guided Theta Burst Stimulation in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Bipolar Disorder (BD) is a common and highly debilitating psychiatric disorder, however, the
      predisposing brain mechanisms are poorly understood. Here, the investigators will conduct a
      proof of concept study that will examine the effect of electroencephalography (EEG)-guided
      theta burst stimulation (TBS) on reducing mania/hypomania-related affect and reward driven
      behavior in adults with BD. The investigators hypothesize that TBS will reduce
      mania/hypomania-related affect and reward driven behavior in adults with BD.
    

Detailed description: 
      This study aims to examine the effect of electroencephalography (EEG)-guided theta burst
      stimulation (TBS) on reducing mania/hypomania-related affect and reward driven behavior in
      adults with BD. Eligible participants will undergo 6 study visits: a screening visit, a
      baseline MRI visit, TBS motor thresholding visit, and 3 cTBS/EEG visits. Participants will
      receive brain stimulation and have brain activity recorded by EEG at each of the 3 cTBS/EEG
      study visits. The research associates (except for the research associate administering the
      TBS) and participants will be blinded to the brain area receiving TBS, which will be
      randomized and counterbalanced beforehand. Certain information is withheld to protect the
      scientific integrity of the study design.

      The goal of the study is to reduce overactivity in the reward neural network (RNet) and
      increase activity in the central executive control network (CEN) using theta burst
      stimulation (TBS). The region in the RNet to be targeted by inhibitory (continuous, cTBS) is
      the left ventrolateral prefrontal cortex (vlPFC); and the region in the CEN to be targeted by
      excitatory (intermittent, iTBS) is the right dorsolateral prefrontal cortex (dlPFC)
    

Intervention name(s): Continuous Theta Burst Stimulation (cTBS); Intermittent Theta Burst Stimulation (iTBS)
Intervention type(s): Device; Device
Intervention description(s): cTBS is a brief stimulation of a part of the brain with a magnetic field that passes through the scalp and skull safely that can decrease the excitability of cortical neurons. It is FDA-approved as a treatment for psychological conditions including depression; however, this device is not approved for the treatment of adults with Bipolar Disorder I or for use in healthy adults. This research study is using the cTBS off label in all participants (those with and without Bipolar Disorder I) to examine research questions; iTBS is a brief stimulation of a part of the brain with a magnetic field that passes through the scalp and skull safely to increase the excitability of cortical neurons. It is FDA-approved as a treatment for psychological conditions including depression; however, this device is not approved for the treatment of adults with Bipolar Disorder I or for use in healthy adults. This research study is using the cTBS off label in all participants (those with and without Bipolar Disorder I) to examine research questions.
Other intervention name(s): Transcranial Magnetic Stimulation (TMS); Transcranial Magnetic Stimulation (TMS)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Bipolar Disorder; Transcranial Magnetic Stimulation; Electroencephalography