Individualized brain stimulation for treating insomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.