Causal Lesion Network Guided Treatment of Bipolar Mania With Transcranial Electrical Stimulation
1 other identifier
interventional
14
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2022
CompletedFirst Posted
Study publicly available on registry
July 6, 2022
CompletedStudy Start
First participant enrolled
December 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedResults Posted
Study results publicly available
November 6, 2025
CompletedNovember 6, 2025
October 1, 2025
2.5 years
June 17, 2022
June 24, 2025
October 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Young Mania Rating Scale (YMRS)
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Change from baseline to 5 Day follow-up
Young Mania Rating Scale (YMRS)
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Change from baseline to 1-month follow-up
Young Mania Rating Scale (YMRS)
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Change from baseline to 3-month follow-up
Altman Self-Rating Mania Scale (ASRM)
The ASRM is a 5-item self rating mania scale, assessing the presence and severity of manic symptoms. The scores for all five items are added together, resulting in a total score that can range from 0 to 20. A score of 6 or higher indicates a high probability of a manic or hypomanic condition.
Change from baseline to 5 Day follow-up
Altman Self-Rating Mania Scale (ASRM)
The ASRM is a 5-item self rating mania scale, assessing the presence and severity of manic symptoms. The scores for all five items are added together, resulting in a total score that can range from 0 to 20. A score of 6 or higher indicates a high probability of a manic or hypomanic condition.
Change from baseline to 1-month follow-up
Altman Self-Rating Mania Scale (ASRM)
The ASRM is a 5-item self rating mania scale, assessing the presence and severity of manic symptoms. The scores for all five items are added together, resulting in a total score that can range from 0 to 20. A score of 6 or higher indicates a high probability of a manic or hypomanic condition.
Change from baseline to 3-month follow-up
Psychiatric Hospitalizations for Mania Post Study Entry
Psychiatric hospitalization for mania. Count of hospitalizations from baseline to end of study period assessed at Day 5, 1 Month \& 3 Month.
Cumulative count of hospitalizations for mania from baseline to end of study
Secondary Outcomes (30)
Balloon Analogue Risk Task (BART)
Change from baseline to 5 Day follow-up
Balloon Analogue Risk Task (BART)
Change from baseline to 1-month follow-up
Balloon Analogue Risk Task (BART)
Change from baseline to 3-month follow-up
The Go/No Go Task
Change from baseline to 5 Day follow-up
The Go/No Go Task
Change from baseline to 1-month follow-up
- +25 more secondary outcomes
Study Arms (3)
HD-tDCS
ACTIVE COMPARATORHD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions)
HD-tACS (alpha, 10 Hz)
ACTIVE COMPARATOR10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
Personalized Beta-Gamma HD-tACS
ACTIVE COMPARATORPersonalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
Interventions
Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
Active-control stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment
Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Substance abuse or dependence (w/in past 6 months)
- Those who are pregnant/breastfeeding
- History of head injury with \> 15 minutes of loss of consciousness/mal sequelae
- DSM-V intellectual disability
- Having a non-removable ferromagnetic metal within the body (particularly in the head)
- History of seizures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Overall recruitment numbers were low which led to small numbers of subjects analyzed.
Results Point of Contact
- Title
- Dr. Paulo Lizano
- Organization
- BIDMC
Study Officials
- PRINCIPAL INVESTIGATOR
Paulo Lizano, MD,PhD
Beth Israel Deaconess Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 17, 2022
First Posted
July 6, 2022
Study Start
December 16, 2022
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
November 6, 2025
Results First Posted
November 6, 2025
Record last verified: 2025-10