Model-Driven Individualized Transcranial Direct Current Stimulation for the Treatment of Insomnia Disorders
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Insomnia
In brief
This study is designed to evaluate the efficacy and to explore the best individualized stimulus paradigm of transcranial Electrical Stimulation for insomnia patients.
Key facts
- Study ID
- NCT06671457
- Run by
- Zhen Wang
- People needed
- 40
- Starts
- 2024-11-10
- Expected to finish
- 2026-04-01
- Last updated by the study team
- 2025-08-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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