Trial Outcomes & Findings for Examining the Effect of EEG-guided Theta Burst Stimulation in Bipolar Disorder (NCT NCT05179785)
NCT ID: NCT05179785
Last Updated: 2024-09-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
1
|
2
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
1
|
2
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Examining the Effect of EEG-guided Theta Burst Stimulation in Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Left vLPFC cTBS/Right dlPFC iTBS/Left Som cTBS
n=3 Participants
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
n=2 Participants
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 Som cTBS/Right dlPFC iTBS/Left vLPFC cTBS
n=1 Participants
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
n=2 Participants
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
n=3 Participants
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)
|
Right dlPFC iTBS/Left vLPFC cTBS/Left Som cTBS
n=2 Participants
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)
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
13 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)Population: One participant was excluded from the EEG data analysis due to lack of immediate choices on the delayed discounting task
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.
Outcome measures
| Measure |
Left vLPFC cTBS
n=12 Participants
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
|
Right dlPFC iTBS
n=12 Participants
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.
|
Left SS cTBS
n=12 Participants
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
|
|---|---|---|---|
|
Brain Activity (Beta Power) in Left vLPFC
Delayed Choice (larger reward in the future)
|
-88.78 Percentage of change post versus pre
Standard Deviation 224.54
|
1437.64 Percentage of change post versus pre
Standard Deviation 4411.75
|
13.43 Percentage of change post versus pre
Standard Deviation 346.26
|
|
Brain Activity (Beta Power) in Left vLPFC
Immediate Choice (small immediate reward)
|
-128.00 Percentage of change post versus pre
Standard Deviation 105.32
|
-612.44 Percentage of change post versus pre
Standard Deviation 1487.43
|
89.70 Percentage of change post versus pre
Standard Deviation 940.52
|
PRIMARY outcome
Timeframe: Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)Population: 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.
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.
Outcome measures
| Measure |
Left vLPFC cTBS
n=12 Participants
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
|
Right dlPFC iTBS
n=12 Participants
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.
|
Left SS cTBS
n=12 Participants
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
|
|---|---|---|---|
|
Brain Activity (Beta Power) in Right vLPFC
Delayed Choice (larger reward in the future)
|
-162.37 Percentage of change post versus pre
Standard Deviation 799.00
|
5.13 Percentage of change post versus pre
Standard Deviation 312.18
|
-498.71 Percentage of change post versus pre
Standard Deviation 1022.00
|
|
Brain Activity (Beta Power) in Right vLPFC
Immediate Choice (small immediate reward)
|
131.99 Percentage of change post versus pre
Standard Deviation 409.07
|
-136.62 Percentage of change post versus pre
Standard Deviation 702.68
|
-117.6 Percentage of change post versus pre
Standard Deviation 893.74
|
PRIMARY outcome
Timeframe: Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)Population: 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.
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.
Outcome measures
| Measure |
Left vLPFC cTBS
n=12 Participants
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
|
Right dlPFC iTBS
n=12 Participants
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.
|
Left SS cTBS
n=12 Participants
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
|
|---|---|---|---|
|
Brain Activity (Beta Power) in Left dlPFC
Delayed Choice (larger reward in the future)
|
33.83 Percentage of change post versus pre
Standard Deviation 446.73
|
-286.13 Percentage of change post versus pre
Standard Deviation 628.89
|
-623.68 Percentage of change post versus pre
Standard Deviation 1950.2
|
|
Brain Activity (Beta Power) in Left dlPFC
Immediate Choice (small immediate reward)
|
32.04 Percentage of change post versus pre
Standard Deviation 322.62
|
-182.53 Percentage of change post versus pre
Standard Deviation 494.97
|
99.64 Percentage of change post versus pre
Standard Deviation 512.78
|
PRIMARY outcome
Timeframe: Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)Population: One participant was excluded from the EEG data analysis due to lack of immediate choices on the delayed discounting task
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.
Outcome measures
| Measure |
Left vLPFC cTBS
n=12 Participants
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
|
Right dlPFC iTBS
n=12 Participants
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.
|
Left SS cTBS
n=12 Participants
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
|
|---|---|---|---|
|
Brain Activity (Beta Power) in Right dlPFC
Immediate Choice (small immediate reward)
|
-128.27 Percentage of change post versus pre
Standard Deviation 363.79
|
-70.27 Percentage of change post versus pre
Standard Deviation 520.40
|
-383.76 Percentage of change post versus pre
Standard Deviation 849.28
|
|
Brain Activity (Beta Power) in Right dlPFC
Delayed Choice (larger reward in the future)
|
-74.21 Percentage of change post versus pre
Standard Deviation 104.49
|
-83.74 Percentage of change post versus pre
Standard Deviation 2072.87
|
-398.00 Percentage of change post versus pre
Standard Deviation 1039.5
|
PRIMARY outcome
Timeframe: Change in magnitude of the functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)Population: 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.
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.
Outcome measures
| Measure |
Left vLPFC cTBS
n=12 Participants
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
|
Right dlPFC iTBS
n=12 Participants
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.
|
Left SS cTBS
n=12 Participants
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
|
|---|---|---|---|
|
Functional Connectivity Between Left and Right vLPFC
Immediate Choice (small immediate reward)
|
3.26 Percentage of change post versus pre
Standard Deviation 8.36
|
-1.28 Percentage of change post versus pre
Standard Deviation 6.19
|
1.07 Percentage of change post versus pre
Standard Deviation 4.16
|
|
Functional Connectivity Between Left and Right vLPFC
Delayed Choice (larger reward in the future)
|
-0.34 Percentage of change post versus pre
Standard Deviation 5.10
|
-1.84 Percentage of change post versus pre
Standard Deviation 4.92
|
0.36 Percentage of change post versus pre
Standard Deviation 3.37
|
PRIMARY outcome
Timeframe: Change in magnitude of functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)Population: One participant was excluded from the EEG data analysis due to lack of immediate choices on the delayed discounting task
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.
Outcome measures
| Measure |
Left vLPFC cTBS
n=12 Participants
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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Right dlPFC iTBS
n=12 Participants
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.
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Left SS cTBS
n=12 Participants
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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Functional Connectivity Between vLPFC and Other RNet Regions
Immediate Choice (small immediate reward)
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3.50 Percentage of change post versus pre
Standard Deviation 8.29
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0.69 Percentage of change post versus pre
Standard Deviation 5.91
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7.03 Percentage of change post versus pre
Standard Deviation 7.58
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Functional Connectivity Between vLPFC and Other RNet Regions
Delayed Choice (larger reward in the future)
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0.52 Percentage of change post versus pre
Standard Deviation 6.68
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-1.03 Percentage of change post versus pre
Standard Deviation 7.97
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-0.38 Percentage of change post versus pre
Standard Deviation 4.99
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PRIMARY outcome
Timeframe: Change in magnitude of functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)Population: 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.
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.
Outcome measures
| Measure |
Left vLPFC cTBS
n=12 Participants
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
|
Right dlPFC iTBS
n=12 Participants
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.
|
Left SS cTBS
n=12 Participants
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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Functional Connectivity Between dlPFC With Other CEN Regions
Delayed Choice (larger reward in the future)
|
2.43 Percentage of change post versus pre
Standard Deviation 5.64
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2.03 Percentage of change post versus pre
Standard Deviation 5.81
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1.13 Percentage of change post versus pre
Standard Deviation 6.16
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Functional Connectivity Between dlPFC With Other CEN Regions
Immediate Choice (small immediate reward)
|
-0.41 Percentage of change post versus pre
Standard Deviation 4.47
|
3.86 Percentage of change post versus pre
Standard Deviation 6.18
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1.44 Percentage of change post versus pre
Standard Deviation 6.17
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SECONDARY outcome
Timeframe: Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)Population: 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.
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.
Outcome measures
| Measure |
Left vLPFC cTBS
n=12 Participants
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
|
Right dlPFC iTBS
n=12 Participants
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.
|
Left SS cTBS
n=12 Participants
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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Brain Activity (Beta Power) in Other RNet and CEN Regions
Delayed Choice (larger reward in the future)(dorsal anterior cingulate cortex)
|
248.65 Percentage of change post versus pre
Standard Deviation 647.87
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-55.98 Percentage of change post versus pre
Standard Deviation 124.11
|
41.73 Percentage of change post versus pre
Standard Deviation 335.39
|
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Brain Activity (Beta Power) in Other RNet and CEN Regions
Immediate Choice (small immediate reward) (dorsal anterior cingulate cortex)
|
-45.54 Percentage of change post versus pre
Standard Deviation 235.51
|
-352.34 Percentage of change post versus pre
Standard Deviation 1075.2
|
928.72 Percentage of change post versus pre
Standard Deviation 2473.59
|
|
Brain Activity (Beta Power) in Other RNet and CEN Regions
Delayed Choice (larger reward in the future) (posterior parietal cortex)
|
-77.80 Percentage of change post versus pre
Standard Deviation 330.51
|
40.06 Percentage of change post versus pre
Standard Deviation 217.51
|
142.64 Percentage of change post versus pre
Standard Deviation 444.57
|
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Brain Activity (Beta Power) in Other RNet and CEN Regions
Immediate Choice (small immediate reward) (posterior parietal cortex)
|
-3.29 Percentage of change post versus pre
Standard Deviation 65.09
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-89.97 Percentage of change post versus pre
Standard Deviation 266.20
|
-156.72 Percentage of change post versus pre
Standard Deviation 289.48
|
SECONDARY outcome
Timeframe: Change in magnitude of functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)Population: 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.
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.
Outcome measures
| Measure |
Left vLPFC cTBS
n=12 Participants
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
|
Right dlPFC iTBS
n=12 Participants
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.
|
Left SS cTBS
n=12 Participants
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
|
|---|---|---|---|
|
Functional Connectivity Among Other RNet and CEN Regions
Delayed Choice (larger reward in the future)(Left vLPFC and Posterior Parietal Cortex)
|
2.45 Percentage of change post versus pre
Standard Deviation 4.33
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-2.10 Percentage of change post versus pre
Standard Deviation 7.23
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1.18 Percentage of change post versus pre
Standard Deviation 4.97
|
|
Functional Connectivity Among Other RNet and CEN Regions
Immediate Choice (small immediate reward) (Left vLPFC and Posterior Parietal Cortex)
|
2.33 Percentage of change post versus pre
Standard Deviation 9.95
|
3.83 Percentage of change post versus pre
Standard Deviation 13.52
|
1.27 Percentage of change post versus pre
Standard Deviation 7.24
|
SECONDARY outcome
Timeframe: 15-30 minutesThe sum (overall total) of the immediate choices (choosing to receive a small immediate reward) made on the delay discounting task
Outcome measures
| Measure |
Left vLPFC cTBS
n=13 Participants
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
|
Right dlPFC iTBS
n=13 Participants
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.
|
Left SS cTBS
n=13 Participants
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
|
|---|---|---|---|
|
Immediate Choices Made on the Delay Discounting Task
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-18.47 percentage of immediate choices changes
Standard Deviation 29.74
|
-9.78 percentage of immediate choices changes
Standard Deviation 29.74
|
-26.28 percentage of immediate choices changes
Standard Deviation 27.38
|
Adverse Events
Left vLPFC cTBS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Right dlPFC iTBS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Left Som cTBS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place