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

NCT06671457 | Recruiting

• 1 other identifier: SMHC-ISM-002
• Study Type: interventional
• Target: 40
• 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

insomnia; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index change

  The change of the Insomnia Severity Index (ISI) score.The scale consists of 7 items, scored on a 5-point Likert scale ranging from 0 to 4 for each item, with a total score ranging from 0 to 28. Higher scores indicate more severe insomnia.

  The study endpoint is set at 2 weeks after the end of treatment

Secondary Outcomes (5)

• Insomnia Severity Index score change

  after tDCS intervention and 4 weeks post-intervention

• response/remission rate

  After tDCS intervention, 2 weeks post-intervention, and 4 weeks post-intervention

• Sleep onset latency, sleep efficiency, and nighttime sleep duration (as defined by the sleep diary).

  After tDCS intervention and 2 weeks post-tDCS intervention

• Hamilton Depression Rating Scale-17 change

  After tDCS intervention, 2 weeks post-tDCS intervention, and 4 weeks post-intervention

• Hamilton Anxiety Rating Scale Change

  After tDCS intervention, 2 weeks post-tDCS intervention, and 4 weeks post-intervention

Study Arms (2)

Active Group

EXPERIMENTAL

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

Device: Active transcranial direct current stimulation

Sham Group

SHAM COMPARATOR

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.

Device: Sham transcranial direct current stimulation

Interventions

Active transcranial direct current stimulation 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

Active Group

Sham transcranial direct current stimulation 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.

Sham Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years;
• Meets the diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
• Has not taken psychiatric medications in the 8 weeks prior to enrollment or has been on stable psychiatric medication for 8 weeks (excluding benzodiazepines);
• Insomnia severity as indicated by an ISI score \> 10;
• Minimum education level of junior high school or above.

You may not qualify if:

• Past or current diagnosis of disorders other than insomnia disorder, anxiety disorder, or depressive disorder according to DSM-5;
• Currently using benzodiazepines as sleep aids;
• Moderate to severe anxiety or depression (HAMD-17 score \> 16 or HAMA score \> 24);
• Patients with obstructive sleep apnea syndrome;
• Previous treatment with ECT, rTMS, tES, or cognitive behavioral therapy for insomnia disorder;
• Severe physical illnesses or any condition that may induce seizures or intracranial hypertension, including cardiovascular or respiratory diseases;
• History of neurological disorders (e.g., epilepsy, cerebrovascular accidents) or history of brain injury or brain surgery;
• Presence of implantable medical devices such as intracranial stents, cardiac pacemakers, coronary stents, or cochlear implants;
• Severe negative thoughts or high suicide risk;
• Pregnant or planning to conceive in the near future.

Sponsors & Collaborators

• Zhen Wang: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

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

Central Study Contacts

Zhen Wang, PhD,MD

CONTACT

+86 34773516; wangzhen@smhc.org.cn

Zhen Wang, PhD,MD

CONTACT

+86 64387250; wangzhen@smhc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: vice president

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: November 10, 2024
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

CN (1)