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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 is a NA study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 14 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05445466
The ClinicalTrials.gov registry entry for NCT05445466 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which High-Definition Transcranial Electrical-Current Stimulation is the first listed.
NCT05445466 reports 0 study locations.
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.
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