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NCT05445466 · ClinicalTrials.gov registry record · NA
Causal Lesion Network Guided Treatment of Bipolar Mania With Transcranial Electrical Stimulation
A NA study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT05445466: Completed NA study, sponsored by Beth Israel Deaconess Medical Center.
NCT05445466 is a NA study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 14 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05445466, a NA study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study 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.
Primary Outcome
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Interventions
- DEVICE High-Definition Transcranial Electrical-Current Stimulation
- DEVICE High-Definition Transcranial Alternate-Current Stimulation
- DEVICE High-Definition Personalized Beta-Gamma Electrical Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-12-16 |
| Est. Completion | 2025-06-01 |
| Phase | NA |
What the finished NCT05445466 record still lists
NCT05445466 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which High-Definition Transcranial Electrical-Current Stimulation is the first listed.
NCT05445466 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05445466 about?
NCT05445466 is a clinical study titled "Causal Lesion Network Guided Treatment of Bipolar Mania With Transcranial Electrical Stimulation". 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 th...
What is the current status of trial NCT05445466?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2022-12-16. Estimated completion is 2025-06-01.
What interventions are being tested in trial NCT05445466?
The interventions under investigation include: High-Definition Transcranial Electrical-Current Stimulation (DEVICE), High-Definition Transcranial Alternate-Current Stimulation (DEVICE), High-Definition Personalized Beta-Gamma Electrical Stimulation (DEVICE).
Who is sponsoring clinical trial NCT05445466?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05445466's enrollment target sits among peer trials
14 1909th of 2000 higher than 90 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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