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

NCT ID: NCT06671457

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-10
• Study Completion Date: 2026-04-01

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.

Detailed Description

This study employs a randomized double-blind placebo-controlled design, with blinding applied to both the assessors and patients, while the therapists remain unblinded. A total of 40 patients with insomnia disorders meeting the inclusion criteria were recruited from the Shanghai Mental Health Center and randomly assigned to either the tDCS active stimulation group or the tDCS sham stimulation group, with 20 patients in each group. All patients underwent clinical assessments, magnetic resonance imaging (MRI) scans, and high-density electroencephalogram (EEG) parameter collections at baseline. Based on the MRI structural images and high-density EEG parameters, individualized modeling was conducted to determine specific stimulation parameter schemes (stimulation sites, stimulation intensity, and electrode placement methods). Detailed modeling methods and selection of stimulation parameters can be found in the intervention methods section. Stimulation was carried out for a total of 2 weeks, with one session per day on weekdays, totaling 10 sessions, each lasting thirty minutes.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Group

To optimize stimulation parameters, electromagnetic modeling and parameter space scanning of the participant's brain are conducted. The specific method includes performing MRI scans before stimulation. MRI structural data is then used to create individualized models of the participant's brain and simulate the electromagnetic fields within biological tissues. High-density EEG is collected during the participant's sleep state, using a 256-channel stimulation-recording device (MagStim EGI, GTEN 200) to record EEG changes induced by stimulation across multiple brain regions. The type of electrical stimulation is cathodal direct current stimulation, targeting brain regions with an intensity equivalent to the traditional 2mA single-channel current, with each electrode not exceeding 200μA. Target brain regions for stimulation include the dorsolateral prefrontal cortex (DLPFC), orbitofrontal cortex (OPFC), medial prefrontal cortex (mPFC), and posterior cingulate cortex (PCC). Changes in brain

Group Type: EXPERIMENTAL

Active transcranial direct current stimulation

Intervention Type: DEVICE

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

Sham Group

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.

Group Type: SHAM_COMPARATOR

Sham transcranial direct current stimulation

Intervention Type: DEVICE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 65 years;

2. Meets the diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)

3. Has not taken psychiatric medications in the 8 weeks prior to enrollment or has been on stable psychiatric medication for 8 weeks (excluding benzodiazepines);

4. Insomnia severity as indicated by an ISI score > 10;

5. Minimum education level of junior high school or above.

Exclusion Criteria

1. Past or current diagnosis of disorders other than insomnia disorder, anxiety disorder, or depressive disorder according to DSM-5;

2. Currently using benzodiazepines as sleep aids;

3. Moderate to severe anxiety or depression (HAMD-17 score > 16 or HAMA score > 24);

4. Patients with obstructive sleep apnea syndrome;

5. Previous treatment with ECT, rTMS, tES, or cognitive behavioral therapy for insomnia disorder;

6. Severe physical illnesses or any condition that may induce seizures or intracranial hypertension, including cardiovascular or respiratory diseases;

7. History of neurological disorders (e.g., epilepsy, cerebrovascular accidents) or history of brain injury or brain surgery;

8. Presence of implantable medical devices such as intracranial stents, cardiac pacemakers, coronary stents, or cochlear implants;

9. Severe negative thoughts or high suicide risk;

10. Pregnant or planning to conceive in the near future.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhen Wang

OTHER

Sponsor Role: lead

Responsible Party

Zhen Wang

vice president

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zhen Wang, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhen Wang, PhD,MD

Role: CONTACT

wangzhen@smhc.org.cn

+86 34773516

Zhen Wang, PhD,MD

Role: CONTACT

wangzhen@smhc.org.cn

+86 64387250

Facility Contacts

Zhen Wang

Role: primary

wangzhen@smhc.org.cn

+86 64387250

Other Identifiers

SMHC-ISM-002

Identifier Type: -

Identifier Source: org_study_id