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RECRUITING
NCT06671457
NA

Model-Driven Individualized Transcranial Direct Current Stimulation for the Treatment of Insomnia Disorders

Sponsor: Zhen Wang

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-11-10

Completion Date

2026-04-01

Last Updated

2025-08-21

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Active transcranial direct current stimulation

The intervention uses transcranial direct current stimulation (tDCS). The targeted brain regions are identified by conducting simultaneous fMRI-EEG data collection and sleep staging, comparing fMRI data between wakefulness and sleep states. Brain regions that show differences are calculated as potential targets for electrical stimulation. If no differentiated regions are found in a participant, specific areas are chosen based on individualized modeling results from previous experiments, targeting areas such as the dorsolateral prefrontal cortex (DLPFC), orbitofrontal cortex (OPFC), medial prefrontal cortex (mPFC), and posterior cingulate cortex (PCC). Two regions are selected within each brain area for parameter scanning (with each stimulation lasting 10 seconds and EEG data recorded 10 seconds before and after stimulation). In our prior studies, we observed a decrease in EEG microstate complexity during sleep, with electrical stimulation influencing this complexity reduction to some

DEVICE

Sham transcranial direct current stimulation

In the sham stimulation group, the placement of the tDCS electrodes is identical to that of the active stimulation group. After the stimulation begins, the current gradually increases over 15 seconds. However, upon reaching the therapeutic current level, it immediately begins to decrease, lowering to 0 mA within 15 seconds and remaining at 0 mA throughout the rest of the session. During the last 15 seconds of the stimulation, there is another gradual decrease in current to 0 mA. This approach creates a similar subjective sensation to the real stimulation, making it difficult for participants to discern which type of electrical stimulation they are receiving.

Locations (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China