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

NCT05445999 | Completed

• 1 other identifier: SMHC-ISM-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Insomnia

Keywords

Transcranial electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index

  The primary outcome is measured as the Insomnia Severity Index (ISI) at baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6, SMHC).

  At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6, SMHC)

Secondary Outcomes (6)

• Pittsburgh Sleep Quality Index (PSQI)

  At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6)

• Change in Beck Depression Inventory, BDI

  At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6)

• Change in Beck Anxiety Inventory, BAI

  At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6)

• Change in Side-effect questionnaire

  At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3 and week 6).

• sleep Diary

  At baseline (prior to treatment), after 10 days of treatment ("post-treatment", week 2) and follow-up periods (weeks 3)

Study Arms (1)

tES treatment

EXPERIMENTAL

Patients will receive ten sessions of daily individualized tDCS over a two-week period, delivered for 20 min at SMHC (sessions 2-11).

Device: High-Definition transcranial electrical stimulation

Interventions

High-Definition transcranial electrical stimulation DEVICE

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.

tES treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200234, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Zhen Wang, PhD,MD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 6, 2022
• Study Start: January 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: September 1, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

CN (1)