NCT06601686

Neuromodulation-assisted Ego-disengagement: The NEURO-EGO Study Stage 1

Neuromodulation-assisted Ego-disengagement: The NEURO-EGO Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn whether brain stimulation technology can help people reach a meditative state quickly and easily without years of meditation training. The researchers want to see if this will help people distance themselves from their thoughts and feeling, and if this will lead to improvements in openness and wellbeing the same way meditation can. Participants will: * Complete questionnaires * Perform a guided meditation task (The Bell Task) * Wear a high density electrocochleography (hdEEG) cap * Undergo brain stimulation * Perform cognitive tasks

Detailed description

This study is being done to evaluate the relative effectiveness of distinct types of non-invasive brain stimulation - NIBS (TES-TI and TES) on subjective ego disengagement and cortical activity in experienced meditators. Phase 1 (registered to this record) involves administering 2 distinct types of deep brain stimulation techniques to a small sample (N=12) of experienced meditators to determine which type of neuromodulation, when focused on disruption of posteromedial cortex (PMC) activity, most robustly facilitates positive ego-disengagement compared to sham; and to discern the region of the PMC where disruption is most effective in achieving ego disengagement. Phase 2 (registered to a separate record, NCT06601699) will use the most effective stimulation and PMC parameters to meditation naïve healthy adults.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Transcranial electrical stimulation (TES)	TES uses specific electrode arrangement patterns to selectively stimulate the brain. Participants will wear an hdEEG (high density electroencephalography) cap which will allow intermittent periods of stimulation from TES.
DEVICE	Transcranial electrical stimulation with temporal interference (TES-TI)	TES-TI uses specific electrode arrangement patterns to selectively stimulate the brain. Participants will wear an hdEEG (high density electroencephalography) cap which will allow intermittent periods of stimulation from TES-TI.
DEVICE	Sham stimulation	TES-TI sham includes receiving stimulation from all electrodes at the same frequency. Sham TES will include administration of transcranial random noise stimulation (tRNS), random oscillating current. It will also include periods with no stimulation and a ramping up period followed by no stimulation.

Timeline

• Start date: 2025-01-08
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2024-09-19
• Last updated: 2025-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study