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| Name | Class |
|---|---|
| Milken Institute | OTHER |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left vLPFC cTBS/right dlPFC iTBS/left Som cTBS | Experimental | 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) |
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| Left vLPFC cTBS/left Som cTBS/right dlPFC iTBS | Experimental | 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) |
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| left Som cTBS/right dlPFC iTBS/Left vLPFC cTBS | Experimental | 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) |
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| left Som cTBS/Left vLPFC cTBS/right dlPFC iTBS |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Theta Burst Stimulation (cTBS) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Activity (Beta Power) in Left vLPFC | 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. | Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
| Brain Activity (Beta Power) in Right vLPFC | 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. | Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
| Brain Activity (Beta Power) in Left dlPFC | 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. | Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
| Brain Activity (Beta Power) in Right dlPFC | 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. | Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
| Functional Connectivity Between Left and Right vLPFC | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Activity (Beta Power) in Other RNet and CEN Regions | 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. | Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary L Phillips, MD, MD | University of Pittsburgh | Principal Investigator |
| Fabio Ferrarelli, MD, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38336341 | Result | Mayeli A, Wang Y, Graur S, Ghane M, Keihani A, Kim A, Janssen S, Huston C, Coffman BA, Ferrarelli F, Phillips ML. Effects of theta burst stimulation on reward processing and decision-making in bipolar disorder: A pilot study. Brain Stimul. 2024 Mar-Apr;17(2):163-165. doi: 10.1016/j.brs.2024.02.002. Epub 2024 Feb 7. No abstract available. |
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Informed consent will be collected from study participants that allows for broad sharing of participants' de-identified data. Data transfer procedures will be in accordance with all Institutional Review Board guidelines and federal regulations including HIPAA.
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The PIs reserve the right to publish on the stated aims in a timely manner during the period of the award. Data will be available for addressing other research questions (i.e. which are not described in funded/pending grants) as soon as the data have been checked for accuracy (a period which will be no later than one year after the completion of each assessment). After the award has ended, the study investigators will continue to test the stated aims, but will also continue to solicit collaborations with outside researchers and to consider data requests in a timely manner.
Outside investigators must submit a 1)proposal of the study aims, hypotheses, variables/constructs, analytic approach, and estimated duration of the proposed research; 2)resume, qualifications, source of financial support, and conflict of interest statement; 3)sign a data-sharing agreement and confidentiality statement that stipulates using the data for the stated research purposes only, securing the data using appropriate computer technology, not manipulating the data in order to identify participants, acknowledging the grant that supported data collection and management in publications/presentations, and destroying or returning the data after analyses are complete; 4)obtain approval from their Institutional Review Board, and along with other staff members who have access to the data, submit certificates of the University of Pittsburgh Education and Certification Program in Research Practice Fundamentals or provide written documentation pf similar human subjects protection training.
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| ID | Title | Description |
|---|---|---|
| FG000 | Left vLPFC cTBS/Right dlPFC iTBS/Left Som 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) Continuous Theta Burst Stimulation (cTBS): 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 Intermittent Theta Burst Stimulation (iTBS): 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. |
| FG001 | Left vLPFC cTBS/Left Som cTBS/Right dlPFC 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) Continuous Theta Burst Stimulation (cTBS): 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 Intermittent Theta Burst Stimulation (iTBS): 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. |
| FG002 | Left Som cTBS/Right dlPFC iTBS/Left vLPFC 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) Continuous Theta Burst Stimulation (cTBS): 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 Intermittent Theta Burst Stimulation (iTBS): 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. |
| FG003 | Left Som cTBS/Left vLPFC cTBS/Right dlPFC 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) Continuous Theta Burst Stimulation (cTBS): 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 Intermittent Theta Burst Stimulation (iTBS): 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. |
| FG004 | Right dlPFC iTBS/Left Som cTBS/Left vLPFC 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) Continuous Theta Burst Stimulation (cTBS): 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 Intermittent Theta Burst Stimulation (iTBS): 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. |
| FG005 | Right dlPFC iTBS/Left vLPFC cTBS/Left Som 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) Continuous Theta Burst Stimulation (cTBS): 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 Intermittent Theta Burst Stimulation (iTBS): 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Left vLPFC cTBS/Right dlPFC iTBS/Left Som 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) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brain Activity (Beta Power) in Left vLPFC | 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. | One participant was excluded from the EEG data analysis due to lack of immediate choices on the delayed discounting task | Posted | Mean | Standard Deviation | Percentage of change post versus pre | Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
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Total participation up to 1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Left vLPFC cTBS | Continuous Theta Burst Stimulation (cTBS): 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Phillips | University of Pittsburgh | 4123838206 | fmristudies@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2021 | Jul 24, 2024 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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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) |
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| right dlPFC iTBS/left Som cTBS/Left vLPFC cTBS | Experimental | 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) |
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| right dlPFC iTBS/Left vLPFC cTBS/left Som cTBS | Experimental | 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) |
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| Intermittent Theta Burst Stimulation (iTBS) | Device | 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. |
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| Change in magnitude of the functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
| Functional Connectivity Between vLPFC and Other RNet Regions | 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. | Change in magnitude of functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
| Functional Connectivity Between dlPFC With Other CEN Regions | 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. | Change in magnitude of functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
| Functional Connectivity Among Other RNet and CEN Regions | 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. | Change in magnitude of functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
| Immediate Choices Made on the Delay Discounting Task | The sum (overall total) of the immediate choices (choosing to receive a small immediate reward) made on the delay discounting task | 15-30 minutes |
| BG001 | Left vLPFC cTBS/Left Som cTBS/Right dlPFC 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) |
| BG002 | Left Som cTBS/Right dlPFC iTBS/Left vLPFC 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) |
| BG003 | Left Som cTBS/Left vLPFC cTBS/Right dlPFC 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) |
| BG004 | Right dlPFC iTBS/Left Som cTBS/Left vLPFC 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) |
| BG005 | Right dlPFC iTBS/Left vLPFC cTBS/Left Som 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) |
| BG006 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Right dlPFC iTBS | Intermittent Theta Burst Stimulation (iTBS): 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. |
| OG002 | Left SS cTBS | Continuous Theta Burst Stimulation (cTBS): 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 |
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| Primary | Brain Activity (Beta Power) in Right vLPFC | 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. | Initially, 10 main outcome measures were stated based on the assumption that 25 participants with bipolar disorder (BD) would be recruited and all data (neuroimaging and behavioral) would be collected from at least 20 participants. However, all data was collected from only 12 BD participants. As such, to not jeopardize the power for the 10 main outcome measures, statistical analyses were performed on only 4 of the 10 outcome measures. | Posted | Mean | Standard Deviation | Percentage of change post versus pre | Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
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| Primary | Brain Activity (Beta Power) in Left dlPFC | 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. | Initially, 10 main outcome measures were stated based on the assumption that 25 participants with bipolar disorder (BD) would be recruited and all data (neuroimaging and behavioral) would be collected from at least 20 participants. However, all data was collected from only 12 BD participants. As such, to not jeopardize the power for the 10 main outcome measures, statistical analyses were performed on only 4 of the 10 outcome measures. | Posted | Mean | Standard Deviation | Percentage of change post versus pre | Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
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| Primary | Brain Activity (Beta Power) in Right dlPFC | 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. | One participant was excluded from the EEG data analysis due to lack of immediate choices on the delayed discounting task | Posted | Mean | Standard Deviation | Percentage of change post versus pre | Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
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| Primary | Functional Connectivity Between Left and Right vLPFC | 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. | Initially, 10 main outcome measures were stated based on the assumption that 25 participants with bipolar disorder (BD) would be recruited and all data (neuroimaging and behavioral) would be collected from at least 20 participants. However, all data was collected from only 12 BD participants. As such, to not jeopardize the power for the 10 main outcome measures, statistical analyses were performed on only 4 of the 10 outcome measures. | Posted | Mean | Standard Deviation | Percentage of change post versus pre | Change in magnitude of the functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
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| Primary | Functional Connectivity Between vLPFC and Other RNet Regions | 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. | One participant was excluded from the EEG data analysis due to lack of immediate choices on the delayed discounting task | Posted | Mean | Standard Deviation | Percentage of change post versus pre | Change in magnitude of functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
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| Primary | Functional Connectivity Between dlPFC With Other CEN Regions | 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. | Initially, 10 main outcome measures were stated based on the assumption that 25 participants with bipolar disorder (BD) would be recruited and all data (neuroimaging and behavioral) would be collected from at least 20 participants. However, all data was collected from only 12 BD participants. As such, to not jeopardize the power for the 10 main outcome measures, statistical analyses were performed on only 4 of the 10 outcome measures. | Posted | Mean | Standard Deviation | Percentage of change post versus pre | Change in magnitude of functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
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| Secondary | Brain Activity (Beta Power) in Other RNet and CEN Regions | 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. | Initially, 10 main outcome measures were stated based on the assumption that 25 participants with bipolar disorder (BD) would be recruited and all data (neuroimaging and behavioral) would be collected from at least 20 participants. However, all data was collected from only 12 BD participants. As such, to not jeopardize the power for the 10 main outcome measures, statistical analyses were performed on only 4 of the 10 outcome measures. | Posted | Mean | Standard Deviation | Percentage of change post versus pre | Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
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| Secondary | Functional Connectivity Among Other RNet and CEN Regions | 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. | Initially, 10 main outcome measures were stated based on the assumption that 25 participants with bipolar disorder (BD) would be recruited and all data (neuroimaging and behavioral) would be collected from at least 20 participants. However, all data was collected from only 12 BD participants. As such, to not jeopardize the power for the 10 main outcome measures, statistical analyses were performed on only 4 of the 10 outcome measures. | Posted | Mean | Standard Deviation | Percentage of change post versus pre | Change in magnitude of functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins) |
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| Secondary | Immediate Choices Made on the Delay Discounting Task | The sum (overall total) of the immediate choices (choosing to receive a small immediate reward) made on the delay discounting task | Posted | Mean | Standard Deviation | percentage of immediate choices changes | 15-30 minutes |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Right dlPFC iTBS | Intermittent Theta Burst Stimulation (iTBS): 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Left Som cTBS | Continuous Theta Burst Stimulation (cTBS): 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 | 0 | 13 | 0 | 13 | 0 | 13 |
Not provided
Not provided
Not provided
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| t-test, 2 sided |
| 0.37517380 |
| Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.47876971 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.21798816 | Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.47876971 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.21798816 | Other |
|
| t-test, 2 sided |
| 0.16043787 |
| Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.67902693 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.33832977 | Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.67902693 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.33832977 | Other |
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| t-test, 2 sided |
| 0.43954526 |
| Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.44198980 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.39565784 | Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.35602382 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.30499144 | Other |
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| t-test, 2 sided |
| 0.20563452 |
| Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.21947623 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.45535329 | Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.21947623 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.45535329 | Other |
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| t-test, 2 sided |
| 0.21582586 |
| Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.59574875 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.75948776 | Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.72384140 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.00477281 | Other |
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| t-test, 2 sided |
| 0.77922802 |
| Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.29196708 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.05605962 | Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.57368284 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.56397238 | Other |
| Immediate Choice (small immediate reward) (dorsal anterior cingulate cortex) |
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| Delayed Choice (larger reward in the future) (posterior parietal cortex) |
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| Immediate Choice (small immediate reward) (posterior parietal cortex) |
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| t-test, 2 sided |
| 0.62228799 |
| Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.79477883 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.12634435 | Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.79477883 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.12634435 | Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.62461968 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.51324793 | Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.60543603 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.75565448 | Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.60543603 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.75565448 | Other |
| Immediate Choice (small immediate reward) (Left vLPFC and Posterior Parietal Cortex) |
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| t-test, 2 sided |
| 0.53980185 |
| Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.30223686 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.39166649 | Other |
| Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.30223686 | Other |
| Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task | t-test, 2 sided | 0.39166649 | Other |
| 0.1053 |
| Other |
| Paired t-test (post versus pre) | t-test, 2 sided | 0.0033 | Other |