Examining the Effect of EEG-guided Theta Burst Stimulation in Bipolar Disorder
- Conditions
- Bipolar Disorder
- Interventions
- Device: Continuous Theta Burst Stimulation (cTBS)Device: Intermittent Theta Burst Stimulation (iTBS)
- Registration Number
- NCT05179785
- Lead Sponsor
- Mary Phillips, MD MD (Cantab)
- Brief 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Left vLPFC cTBS/left Som cTBS/right dlPFC iTBS Continuous Theta Burst Stimulation (cTBS) 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) Left vLPFC cTBS/right dlPFC iTBS/left Som cTBS Continuous Theta Burst Stimulation (cTBS) 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) Left vLPFC cTBS/left Som cTBS/right dlPFC iTBS Intermittent Theta Burst Stimulation (iTBS) 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) right dlPFC iTBS/left Som cTBS/Left vLPFC cTBS Continuous Theta Burst Stimulation (cTBS) 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) left Som cTBS/right dlPFC iTBS/Left vLPFC cTBS Continuous Theta Burst Stimulation (cTBS) 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) left Som cTBS/Left vLPFC cTBS/right dlPFC iTBS Continuous Theta Burst Stimulation (cTBS) 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) right dlPFC iTBS/left Som cTBS/Left vLPFC cTBS Intermittent Theta Burst Stimulation (iTBS) 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) Left vLPFC cTBS/right dlPFC iTBS/left Som cTBS Intermittent Theta Burst Stimulation (iTBS) 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) left Som cTBS/right dlPFC iTBS/Left vLPFC cTBS Intermittent Theta Burst Stimulation (iTBS) 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) right dlPFC iTBS/Left vLPFC cTBS/left Som cTBS Continuous Theta Burst Stimulation (cTBS) 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) left Som cTBS/Left vLPFC cTBS/right dlPFC iTBS Intermittent Theta Burst Stimulation (iTBS) 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) right dlPFC iTBS/Left vLPFC cTBS/left Som cTBS Intermittent Theta Burst Stimulation (iTBS) 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)
- Primary Outcome Measures
Name Time Method Brain Activity (Beta Power) in Left vLPFC Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) The difference in brain activity (Beta power) in left vLPFC from pre TBS to post TBS. Higher numbers indicate more brain activity after TBS, while lower numbers indicate less brain activity (Beta power) after TBS.
Brain Activity (Beta Power) in Right vLPFC Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) The difference in brain activity (Beta power) in right vLPFC from pre TBS to post TBS. Higher numbers indicate more brain activity (Beta power) after TBS, while lower numbers indicate less brain activity (Beta power) after TBS.
Brain Activity (Beta Power) in Left dlPFC Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) The difference in brain activity (Beta power) in left dLPFC from pre TBS to post TBS. Higher numbers indicate more brain activity (Beta power) after TBS, while lower numbers indicate less brain activity (Beta power) after TBS.
Brain Activity (Beta Power) in Right dlPFC Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) The difference in brain activity (Beta power) in right dLPFC from pre TBS to post TBS. Higher numbers indicate more brain activity (Beta power) after TBS, while lower numbers indicate less brain activity (Beta power) after TBS.
Functional Connectivity Between Left and Right vLPFC Change in magnitude of the functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) The difference in functional connectivity (a measure of interactions between 2 brain regions) among left and right vLPFC from preTBS to post TBS. Higher numbers indicate more functional connectivity after TBS, while lower numbers indicate less functional connectivity after TBS.
Functional Connectivity Between vLPFC and Other RNet Regions Change in magnitude of functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) The difference in functional connectivity (a measure of interactions between 2 brain regions) among vLPFC and other RNet regions from pre TBS to post TBS. Higher numbers indicate more functional connectivity after TBS, while lower numbers indicate less functional connectivity after TBS.
Functional Connectivity Between dlPFC With Other CEN Regions Change in magnitude of functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) The difference in functional connectivity (a measure of interactions between 2 brain regions) among dlPFC and other RNet regions from pre TBS to post TBS. Higher numbers indicate more functional connectivity after TBS, while lower numbers indicate less functional connectivity after TBS.
- Secondary Outcome Measures
Name Time Method Brain Activity (Beta Power) in Other RNet and CEN Regions Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) The difference in brain activity (Beta power) among other RNet and CEN regions from pre TBS to post TBS. Higher numbers indicate more brain activity (Beta power) after TBS, while lower numbers indicate less brain activity (Beta power) after TBS.
Functional Connectivity Among Other RNet and CEN Regions Change in magnitude of functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) The difference in functional connectivity (a measure of interactions between 2 brain regions) among other RNet and CEN regions from pre TBS to post TBS. Higher numbers indicate more functional connectivity after TBS, while lower numbers indicate less functional connectivity after TBS.
Immediate Choices Made on the Delay Discounting Task 15-30 minutes The sum (overall total) of the immediate choices (choosing to receive a small immediate reward) made on the delay discounting task
Trial Locations
- Locations (1)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States