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

NCT05445999 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-25

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Shanghai Mental Health Center

    lead OTHER

Principal Investigators

  • Zhen Wang, PhD,MD · Shanghai Mental Health Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-12-30
Completion
2025-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05445999 on ClinicalTrials.gov