NCT05445466Completed
Causal Lesion Network Guided Treatment of Bipolar Mania With Transcranial Electrical Stimulation
Source: ClinicalTrials.gov · Last updated 6 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 17 Jun 2022
- Start date
- 16 Dec 2022
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Diseases
- Bipolar disorder
- NCT number
- NCT05445466
What you commit to
- Study type: Interventional
- Participants enrolled: 14
- From 16 Dec 2022 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of head injury with \> 15 minutes of loss of consciousness/mal sequelae
- History of seizures
Other
- Substance abuse or dependence (w/in past 6 months)
- Those who are pregnant/breastfeeding
- DSM-V intellectual disability
- Having a non-removable ferromagnetic metal within the body (particularly in the head)
Who the study is looking for
- Aged 18-65 years of age
- Proficient in English
- Able to give informed consent
- Meet diagnostic criteria for bipolar disorder or schizoaffective disorder, bipolar type as verified by the SCID
- History of mania ( \>1 lifetime episode)
- Experiencing mild to moderate symptoms of mania
- No changes to mood stabilizing medications for a period of 2 weeks prior to participation
- Has not recently participated in tES/TMS treatments
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.