CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
High-Definition Transcranial Electrical-Current Stimulation +2 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/NCT05445466
NCT05445466N/ACompleted

Causal Lesion Network Guided Treatment of Bipolar Mania With Transcranial Electrical Stimulation

Beth Israel Deaconess Medical Center·interventional·Posted Jul 6, 2022·Updated Nov 6, 2025

In Brief

A clinical study evaluating High-Definition Transcranial Electrical-Current Stimulation, High-Definition Transcranial Alternate-Current Stimulation, and 1 other intervention for Bipolar Disorder and Schizo Affective Disorder. Completed, enrolled 14 participants across 1 site.

Detailed Summary

Mania is a core symptom of bipolar disorder involving periods of euphoria. Decreased inhibitory control, increased risk-taking behaviors, and aberrant reward processing are some of the more recognized symptoms of bipolar disorder and are included in the diagnostic criteria for mania. Current drug therapies for mania are frequently intolerable, ineffective, and carry significant risk for side effects. Presently there are no neurobiologically informed therapies that treat or prevent mania. However, using a newly validated technique termed lesion network mapping, researchers demonstrated that focal brain lesions having a causal role in the development of mania in people without a psychiatric history can occur in different brain locations, such as the right orbitofrontal cortex (OFC), right dorsolateral prefrontal cortex (DLPFC), and right inferior temporal gyrus (ITG). This lesion network evidence converges with existing cross-sectional and longitudinal observations in bipolar mania that have identified specific disruptions in network communication between the amygdala and ventro-lateral prefrontal cortex. The OFC is associated with inhibitory control, risk-taking behavior, and reward learning which are major components of bipolar mania. Thus, the association between OFC with mania symptoms, inhibitory control, risk-taking behavior, and reward processing suggests that this region could be targeted using non-invasive brain stimulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 6, 2022
Enrollment StartDec 16, 2022
Primary CompletionJun 1, 2025
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 4.0 years ago

Interventions

High-Definition Transcranial Electrical-Current Stimulationdevice

Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment

High-Definition Transcranial Alternate-Current Stimulationdevice

Active-control stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment

High-Definition Personalized Beta-Gamma Electrical Stimulationdevice

Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment