NCT05179785

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

Completed NA Results posted Last updated 19 September 2024

What this trial tests

NA trial testing Continuous Theta Burst Stimulation (cTBS) in Bipolar Disorder in 13 participants. Completed in 31 July 2023.

Timeline

23 March 2022

Primary endpoint
31 July 2023

31 July 2023

Quick facts

Lead sponsor	Mary Phillips, MD MD (Cantab)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	basic science
Enrollment	13
Start date	23 March 2022
Primary completion	31 July 2023
Estimated completion	31 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Continuous Theta Burst Stimulation (cTBS)
• Intermittent Theta Burst Stimulation (iTBS)

Conditions studied

• Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

Mary Phillips, MD MD (Cantab)

Who can join

Adults 18 to 35, any sex, with Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Brain Activity (Beta Power) in Left vLPFC Primary · Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)

The difference in brain activity (Beta power) in left vLPFC from pre TBS to post TBS. Higher numbers indicate more brain activity after TBS, while lower numbers indicate less brain activity (Beta power) after TBS.

Delayed Choice (larger reward in the future)

Group	Value	95% CI
Left vLPFC cTBS	-88.78	± 224.54
Right dlPFC iTBS	1437.64	± 4411.75
Left SS cTBS	13.43	± 346.26

Immediate Choice (small immediate reward)

Group	Value	95% CI
Left vLPFC cTBS	-128.00	± 105.32
Right dlPFC iTBS	-612.44	± 1487.43
Left SS cTBS	89.70	± 940.52

Brain Activity (Beta Power) in Right vLPFC Primary · Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)

The difference in brain activity (Beta power) in right vLPFC from pre TBS to post TBS. Higher numbers indicate more brain activity (Beta power) after TBS, while lower numbers indicate less brain activity (Beta power) after TBS.

Delayed Choice (larger reward in the future)

Group	Value	95% CI
Left vLPFC cTBS	-162.37	± 799.00
Right dlPFC iTBS	5.13	± 312.18
Left SS cTBS	-498.71	± 1022.00

Immediate Choice (small immediate reward)

Group	Value	95% CI
Left vLPFC cTBS	131.99	± 409.07
Right dlPFC iTBS	-136.62	± 702.68
Left SS cTBS	-117.6	± 893.74

Brain Activity (Beta Power) in Left dlPFC Primary · Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)

The difference in brain activity (Beta power) in left dLPFC from pre TBS to post TBS. Higher numbers indicate more brain activity (Beta power) after TBS, while lower numbers indicate less brain activity (Beta power) after TBS.

Delayed Choice (larger reward in the future)

Group	Value	95% CI
Left vLPFC cTBS	33.83	± 446.73
Right dlPFC iTBS	-286.13	± 628.89
Left SS cTBS	-623.68	± 1950.2

Immediate Choice (small immediate reward)

Group	Value	95% CI
Left vLPFC cTBS	32.04	± 322.62
Right dlPFC iTBS	-182.53	± 494.97
Left SS cTBS	99.64	± 512.78

Brain Activity (Beta Power) in Right dlPFC Primary · Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)

The difference in brain activity (Beta power) in right dLPFC from pre TBS to post TBS. Higher numbers indicate more brain activity (Beta power) after TBS, while lower numbers indicate less brain activity (Beta power) after TBS.

Immediate Choice (small immediate reward)

Group	Value	95% CI
Left vLPFC cTBS	-128.27	± 363.79
Right dlPFC iTBS	-70.27	± 520.40
Left SS cTBS	-383.76	± 849.28

Delayed Choice (larger reward in the future)

Group	Value	95% CI
Left vLPFC cTBS	-74.21	± 104.49
Right dlPFC iTBS	-83.74	± 2072.87
Left SS cTBS	-398.00	± 1039.5

Functional Connectivity Between Left and Right vLPFC Primary · Change in magnitude of the functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)

The difference in functional connectivity (a measure of interactions between 2 brain regions) among left and right vLPFC from preTBS to post TBS. Higher numbers indicate more functional connectivity after TBS, while lower numbers indicate less functional connectivity after TBS.

Delayed Choice (larger reward in the future)

Group	Value	95% CI
Left vLPFC cTBS	-0.34	± 5.10
Right dlPFC iTBS	-1.84	± 4.92
Left SS cTBS	0.36	± 3.37

Immediate Choice (small immediate reward)

Group	Value	95% CI
Left vLPFC cTBS	3.26	± 8.36
Right dlPFC iTBS	-1.28	± 6.19
Left SS cTBS	1.07	± 4.16

Functional Connectivity Between vLPFC and Other RNet Regions Primary · Change in magnitude of functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)

The difference in functional connectivity (a measure of interactions between 2 brain regions) among vLPFC and other RNet regions from pre TBS to post TBS. Higher numbers indicate more functional connectivity after TBS, while lower numbers indicate less functional connectivity after TBS.

Delayed Choice (larger reward in the future)

Group	Value	95% CI
Left vLPFC cTBS	0.52	± 6.68
Right dlPFC iTBS	-1.03	± 7.97
Left SS cTBS	-0.38	± 4.99

Immediate Choice (small immediate reward)

Group	Value	95% CI
Left vLPFC cTBS	3.50	± 8.29
Right dlPFC iTBS	0.69	± 5.91
Left SS cTBS	7.03	± 7.58

Functional Connectivity Between dlPFC With Other CEN Regions Primary · Change in magnitude of functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)

The difference in functional connectivity (a measure of interactions between 2 brain regions) among dlPFC and other RNet regions from pre TBS to post TBS. Higher numbers indicate more functional connectivity after TBS, while lower numbers indicate less functional connectivity after TBS.

Delayed Choice (larger reward in the future)

Group	Value	95% CI
Left vLPFC cTBS	2.43	± 5.64
Right dlPFC iTBS	2.03	± 5.81
Left SS cTBS	1.13	± 6.16

Immediate Choice (small immediate reward)

Group	Value	95% CI
Left vLPFC cTBS	-0.41	± 4.47
Right dlPFC iTBS	3.86	± 6.18
Left SS cTBS	1.44	± 6.17

Brain Activity (Beta Power) in Other RNet and CEN Regions Secondary · Change in magnitude of brain activity (Beta power) immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)

The difference in brain activity (Beta power) among other RNet and CEN regions from pre TBS to post TBS. Higher numbers indicate more brain activity (Beta power) after TBS, while lower numbers indicate less brain activity (Beta power) after TBS.

Delayed Choice (larger reward in the future)(dorsal anterior cingulate cortex)

Group	Value	95% CI
Left vLPFC cTBS	248.65	± 647.87
Right dlPFC iTBS	-55.98	± 124.11
Left SS cTBS	41.73	± 335.39

Immediate Choice (small immediate reward) (dorsal anterior cingulate cortex)

Group	Value	95% CI
Left vLPFC cTBS	-45.54	± 235.51
Right dlPFC iTBS	-352.34	± 1075.2
Left SS cTBS	928.72	± 2473.59

Delayed Choice (larger reward in the future) (posterior parietal cortex)

Group	Value	95% CI
Left vLPFC cTBS	-77.80	± 330.51
Right dlPFC iTBS	40.06	± 217.51
Left SS cTBS	142.64	± 444.57

Immediate Choice (small immediate reward) (posterior parietal cortex)

Group	Value	95% CI
Left vLPFC cTBS	-3.29	± 65.09
Right dlPFC iTBS	-89.97	± 266.20
Left SS cTBS	-156.72	± 289.48

Functional Connectivity Among Other RNet and CEN Regions Secondary · Change in magnitude of functional connectivity immediately before and immediately after each TBS condition at EEG/TBS visits (15-30 mins)

The difference in functional connectivity (a measure of interactions between 2 brain regions) among other RNet and CEN regions from pre TBS to post TBS. Higher numbers indicate more functional connectivity after TBS, while lower numbers indicate less functional connectivity after TBS.

Delayed Choice (larger reward in the future)(Left vLPFC and Posterior Parietal Cortex)

Group	Value	95% CI
Left vLPFC cTBS	2.45	± 4.33
Right dlPFC iTBS	-2.10	± 7.23
Left SS cTBS	1.18	± 4.97

Immediate Choice (small immediate reward) (Left vLPFC and Posterior Parietal Cortex)

Group	Value	95% CI
Left vLPFC cTBS	2.33	± 9.95
Right dlPFC iTBS	3.83	± 13.52
Left SS cTBS	1.27	± 7.24

Immediate Choices Made on the Delay Discounting Task Secondary · 15-30 minutes

The sum (overall total) of the immediate choices (choosing to receive a small immediate reward) made on the delay discounting task

Group	Value	95% CI
Left vLPFC cTBS	-18.47	± 29.74
Right dlPFC iTBS	-9.78	± 29.74
Left SS cTBS	-26.28	± 27.38

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.