Trial results for a study investigating Causal Lesion Network Guided Treatment of Bipolar Mania With Transcranial Electrical Stimulation for Bipolar Disorder and Schizoaffective Disorder were posted on ClinicalTrials.gov on 2025-11-06, with 14 participants enrolled.
Background
Mania is a core symptom of bipolar disorder, characterized by periods of euphoria, decreased inhibitory control, increased risk-taking behaviors, and aberrant reward processing. Current pharmacological treatments for mania often present challenges, including tolerability issues, variable efficacy, and significant side effects. There is a recognized need for neurobiologically informed therapies to treat or prevent mania. This study explored the use of a technique called lesion network mapping to guide transcranial electrical stimulation.
Trial design
This completed study, designated as Phase NA, enrolled 14 participants. The trial investigated conditions including Bipolar Disorder and Schizo Affective Disorder. The interventions explored were various forms of transcranial electrical stimulation, specifically High-Definition transcranial Direct Current Stimulation (HD-tDCS), High-Definition transcranial Alternating Current Stimulation (HD-tACS) at Alpha (10 Hz), and Personalized Beta-Gamma tACS. The trial aimed to assess outcomes related to mania.
Key results
The trial reported several median scores on the Young Mania Rating Scale (YMRS) for the different intervention groups:
- HD-tDCS:
- A median YMRS score of 5.5 (score on a scale) was observed.
- Another median YMRS score was 3 (score on a scale).
- A further median YMRS score was 5.5 (score on a scale).
- A fourth median YMRS score was 1.5 (score on a scale).
- HD-tACS (Alpha, 10 Hz):
- A median YMRS score of 11.8 (score on a scale) was observed.
- Another median YMRS score was 8 (score on a scale).
- A further median YMRS score was 11.8 (score on a scale).
- A fourth median YMRS score was 11 (score on a scale).
- Personalized Beta-Gamma tACS:
- A median YMRS score of 7.5 (score on a scale) was observed.
- Another median YMRS score was 3 (score on a scale).
- A further median YMRS score was 7.5 (score on a scale).
- A fourth median YMRS score was 4 (score on a scale).
What this means
The posted results provide median Young Mania Rating Scale scores for a small cohort of 14 participants across different transcranial electrical stimulation interventions. The observed median scores vary among the HD-tDCS, HD-tACS (Alpha, 10 Hz), and Personalized Beta-Gamma tACS groups. These initial measurements contribute to the understanding of how these specific stimulation approaches might influence mania symptoms in individuals with bipolar disorder or schizoaffective disorder. Given the small enrollment, these results are preliminary and would require further investigation in larger studies to determine clinical significance and efficacy.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05445466, titled "Causal Lesion Network Guided Treatment of Bipolar Mania With Transcranial Electrical Stimulation", were posted on 2025-11-06 on clinicaltrials.gov.