N/A N=14 Randomized Quadruple-blind Treatment

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

Bipolar Disorder · Schizo Affective Disorder

Bottom Line

View on ClinicalTrials.gov: NCT05445466 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2025

Primary outcome: Primary: Young Mania Rating Scale (YMRS) — 5.5; 11.8; 7.5; 3 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: High-Definition Transcranial Electrical-Current Stimulation (Device); High-Definition Transcranial Alternate-Current Stimulation (Device); High-Definition Personalized Beta-Gamma Electrical Stimulation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Beth Israel Deaconess Medical Center
Primary completion: Jun 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Young Mania Rating Scale (YMRS)	5.5; 11.8; 7.5; 2.6; 7.5; 2	—
PRIMARY Young Mania Rating Scale (YMRS)	5.5; 11.8; 7.5; 2.6; 7.5; 2	—
PRIMARY Young Mania Rating Scale (YMRS)	5.5; 11.8; 7.5; 2.6; 7.5; 2	—
PRIMARY Altman Self-Rating Mania Scale (ASRM)	5; 7; 3; 2; 3.6; 6	—
PRIMARY Altman Self-Rating Mania Scale (ASRM)	5; 7; 3; 2; 3.6; 6	—
PRIMARY Altman Self-Rating Mania Scale (ASRM)	5; 7; 3; 2; 3.6; 6	—
PRIMARY Psychiatric Hospitalizations for Mania Post Study Entry	0; 0; 0; 0; 0; 0	—
SECONDARY Balloon Analogue Risk Task (BART)	16; 13.5; 13; 12.2; 14.7; 18	—
SECONDARY Balloon Analogue Risk Task (BART)	16; 13.5; 13; 12.2; 14.7; 18	—
SECONDARY Balloon Analogue Risk Task (BART)	16; 13.5; 13; 12.2; 14.7; 18	—
SECONDARY The Go/No Go Task	876.9768638; 954.3716154; 859.6685714; 931.8461538; 925.0182573; 845.64	—
SECONDARY The Go/No Go Task	876.9768638; 954.3716154; 859.6685714; 931.8461538; 925.0182573; 845.64	—
SECONDARY The Go/No Go Task	876.9768638; 954.3716154; 859.6685714; 931.8461538; 925.0182573; 845.64	—
SECONDARY Electroencephalography (EEG) Resting State	-9.261; -7.555; -6.410; -13.336; -8.834; -11.185	—
SECONDARY Electroencephalography (EEG) Resting State	-9.261; -7.555; -6.410; -13.336; -8.834; -11.185	—
SECONDARY Electroencephalography (EEG) Resting State	-9.261; -7.555; -6.410; -13.336; -8.834; -11.185	—
SECONDARY Reinforcement Learning Task	26; 25.25; 32; 25.5; 29.25; 27.5	—
SECONDARY Reinforcement Learning Task	26; 25.25; 32; 25.5; 29.25; 27.5	—
SECONDARY Reinforcement Learning Task	26; 25.25; 32; 25.5; 29.25; 27.5	—
SECONDARY Social Functioning Scale (SFS)	161; 125.5; 142; 156.6; 127.2; 150	—
SECONDARY Social Functioning Scale (SFS)	161; 125.5; 142; 156.6; 127.2; 150	—
SECONDARY Social Functioning Scale (SFS)	161; 125.5; 142; 156.6; 127.2; 150	—
SECONDARY Global Assessment of Functioning (GAF)	65; 46; 59; 65; 52.1; 61	—
SECONDARY Global Assessment of Functioning (GAF)	65; 46; 59; 65; 52.1; 61	—
SECONDARY Global Assessment of Functioning (GAF)	65; 46; 59; 65; 52.1; 61	—
SECONDARY Positive and Negative Syndrome Scale (PANSS)	49; 71; 68; 54.8; 73.3; 52	—
SECONDARY Positive and Negative Syndrome Scale (PANSS)	49; 71; 68; 54.8; 73.3; 52	—
SECONDARY Positive and Negative Syndrome Scale (PANSS)	49; 71; 68; 54.8; 73.3; 52	—
SECONDARY Montgomery-Åsberg Depression Rating Scale (MADRS)	8; 17.5; 10; 8; 19.2; 6	—
SECONDARY Montgomery-Åsberg Depression Rating Scale (MADRS)	8; 17.5; 10; 8; 19.2; 6	—
SECONDARY Montgomery-Åsberg Depression Rating Scale (MADRS)	8; 17.5; 10; 8; 19.2; 6	—
SECONDARY Barratt Impulsiveness Scale-11 (BIS-11)	37; 35; 42; 35.2; 38; 36	—
SECONDARY Barratt Impulsiveness Scale-11 (BIS-11)	37; 35; 42; 35.2; 38; 36	—
SECONDARY Barratt Impulsiveness Scale-11 (BIS-11)	37; 35; 42; 35.2; 38; 36	—
SECONDARY Brief Assessment of Cognition (BACS)	0.44; -0.66; 0.25; 0.18; -0.602; 0.97	—
SECONDARY Brief Assessment of Cognition (BACS)	0.44; -0.66; 0.25; 0.18; -0.602; 0.97	—
SECONDARY Brief Assessment of Cognition (BACS)	0.44; -0.66; 0.25; 0.18; -0.602; 0.97	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05445466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.