NCT06671457 Model-Driven Individualized Transcranial Direct Current Stimulation for the Treatment of Insomnia Disorders
| NCT ID | NCT06671457 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhen Wang |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-11-10 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-11-10 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Zhen Wang, PhD,MD
PRINCIPAL INVESTIGATOR
Shanghai Mental Health Center
Frequently Asked Questions
Who can join the NCT06671457 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06671457 currently recruiting?
Yes, NCT06671457 is actively recruiting participants. Contact the research team at wangzhen@smhc.org.cn for enrollment information.
Where is the NCT06671457 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06671457 clinical trial?
NCT06671457 is sponsored by Zhen Wang. The principal investigator is Zhen Wang, PhD,MD at Shanghai Mental Health Center. The trial plans to enroll 40 participants.
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