Individualized brain stimulation for treating insomnia
Model-Driven Individualized Transcranial Direct Current Stimulation for the Treatment of Insomnia Disorders
This study is testing whether personalized brain stimulation can help people with insomnia sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shanghai Mental Health Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06671457 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of individualized transcranial direct current stimulation (tDCS) for patients suffering from insomnia. It utilizes a randomized double-blind placebo-controlled design, involving 40 participants who are assigned to either an active or sham stimulation group. Participants undergo clinical assessments, MRI scans, and EEG parameter collections to tailor the stimulation parameters specifically to their needs. The stimulation sessions are conducted over two weeks, with each session lasting thirty minutes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who meet the diagnostic criteria for insomnia disorder and have a severity score indicating significant insomnia.
Not a fit: Patients with other primary psychiatric disorders, severe anxiety or depression, or those currently using benzodiazepines may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel, non-pharmacological treatment option for patients with insomnia.
How similar studies have performed: While the use of tDCS is gaining interest, this specific individualized approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Zhen Wang, PhD,MD — Shanghai Mental Health Center
- Study coordinator: Zhen Wang, PhD,MD
- Email: wangzhen@smhc.org.cn
- Phone: +86 34773516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.