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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT05445466
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • High-Definition Transcranial Electrical-Current Stimulation — DEVICE
    Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
  • High-Definition Transcranial Alternate-Current Stimulation — DEVICE
    Active-control stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment
  • High-Definition Personalized Beta-Gamma Electrical Stimulation — DEVICE
    Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment

Study Details

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.

Key Dates

Start date
Dec 16, 2022
Status verified
Oct 2025
Primary completion
Jun 1, 2025
Completion
Jun 1, 2025

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: HD-tDCS
    HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions)
  • Active Comparator: HD-tACS (alpha, 10 Hz)
    10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
  • Active Comparator: Personalized Beta-Gamma HD-tACS
    Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).

Primary Outcome Measure

Young Mania Rating Scale (YMRS) [ Time Frame: Change from baseline to 5 Day follow-up ]

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-

Find similar trials in Boston, MA

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
Beth Israel Deaconess Medical Center· Boston, MA

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