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

Not Applicable

Recruiting

• Conditions: Insomnia

• Registration Number: NCT06671457
• Lead Sponsor: Zhen Wang

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-31
• Study First Submitted QC: 2024-10-31
• Study First Posted: 2024-11-04
• Study Start: 2024-11-10
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-12-30
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index change	The study endpoint is set at 2 weeks after the end of treatment	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.

Secondary Outcome Measures

Name	Time	Method
Insomnia Severity Index score change	after tDCS intervention and 4 weeks post-intervention	the change in the Insomnia Severity Index (ISI) score after tDCS intervention and 4 weeks post-intervention.
response/remission rate	After tDCS intervention, 2 weeks post-intervention, and 4 weeks post-intervention	Treatment effectiveness is defined as a reduction of more than 7 points in the Insomnia Severity Index (ISI) score post-treatment. Clinical remission is defined as a total ISI score of less than 8 points.
Sleep onset latency, sleep efficiency, and nighttime sleep duration (as defined by the sleep diary).	After tDCS intervention and 2 weeks post-tDCS intervention	Changes in sleep onset latency, sleep efficiency, and nighttime sleep duration 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 Depression Rating Scale 17 score change after tDCS intervention, 2 weeks post-tDCS intervention, and 4 weeks post-intervention. For the HDRS17 , a score of 0-7 is generally accepted to be within the normal Hamilton Depression Rating Scale (HDRS) range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial. Higher scores indicate more severe depression.
Hamilton Anxiety Rating Scale Change	After tDCS intervention, 2 weeks post-tDCS intervention, and 4 weeks post-intervention	Hamilton Anxiety Rating Scale score change after tDCS intervention, 2 weeks post-tDCS intervention, and 4 weeks post-intervention.Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China