NCT05445999

A Preliminary Study of Model-driven Individualized Transcranial Electrical Stimulation for Insomnia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and to explore the best individualized stimulus paradigm of transcranial Electrical Stimulation for insomnia patients.

Detailed description

This study is an open-label clinical trial. A total of 40 patients with insomnia who meet the inclusion and exclusion of criteria will be recruited from the SMHC (20) and be assigned to receive individualized tDCS treatment. Patients will undergo ten days of daily individualized tDCS treatment for 20 min (sessions 2-11, SMHC) over a two-week period, which session 7 of patients for re-screening of tDCS target. In addition, normal control subjects and insomnia patients meeting eligibility criteria will be recruited from SMHC to identify biomarkers of wakefulness and sleep through simultaneous fMRI-EEG and high-density EEG recordings. These participants will not receive tDCS and will serve as controls for comparison with the treatment group.

Conditions

• Insomnia

Interventions

Type	Name	Description
DEVICE	High-Definition transcranial electrical stimulation	The first and final sessions will include clinical assessments and acquisition of MRI and EEG data. To minimize variability, each patient will undergo tDCS at a consistent time in the afternoon or evening and will remain lying in bed with eyes closed throughout stimulation. Stimulation will be delivered using the GTEN 200 system (Magstim EGI, Oregon, USA), which also enables simultaneous EEG recording. The stimulation current will be limited to 1.5 mA, with a maximum of 0.15 mA per electrode (up to 20 electrodes). Electrode placement and current intensity will be individualized to achieve the targeted electric field strength (0.1 or 0.2 V/m at SMHC;). Each session will include 5 min of resting-state EEG immediately before and after stimulation to assess tDCS-induced changes in brain dynamics. Current onset and offset will be gradual, with 2-s ramp-up and ramp-down periods.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-30
• Completion: 2025-09-01
• First posted: 2022-07-06
• Last updated: 2025-09-25

Locations

1 site across 1 country: China