CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
Continuous Theta Burst Stimulation (cTBS) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05179785
NCT05179785N/ACompleted
CompareCT.gov

Establishing the Effect of Electroencephalography (EEG)-Guided Theta Burst Stimulation on Reducing Mania/Hypomania-related Affect and Reward Driven Behavior in Bipolar Disorder

Mary Phillips, MD MD (Cantab)·interventional·Posted Jan 5, 2022·Updated Sep 19, 2024

In Brief

A clinical study evaluating Continuous Theta Burst Stimulation (cTBS) and Intermittent Theta Burst Stimulation (iTBS) for Bipolar Disorder. Completed, enrolled 13 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsMilken Institute

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 5, 2022
Enrollment StartMar 23, 2022
Primary CompletionJul 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.5 years ago

Interventions

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

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.