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

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.

Conditions

• Bipolar Disorder
• Schizo Affective Disorder

Interventions

DEVICE

High-Definition Transcranial Electrical-Current Stimulation

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

DEVICE

High-Definition Transcranial Alternate-Current Stimulation

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

DEVICE

High-Definition Personalized Beta-Gamma Electrical Stimulation

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center

  lead OTHER

Principal Investigators

• Paulo Lizano, MD,PhD · Beth Israel Deaconess Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-16

Primary Completion

2025-06-01

Completion

2025-06-01

FDA Device

Yes

Countries

• United States

Study Locations