Personalized brain stimulation treatment for major depression
Repetitive Transcranial Magnetic Stimulation(rTMS) Treatment Based on Personalized Modulation of Electroencephalography Promotes Symptom Remission in Major Depressive Disorder (MDD) - A Randomized Controlled Clinical Trial
This study is testing a personalized brain stimulation treatment for major depression to see if it can help people feel better by using brain wave data to tailor the therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Shanghai Mental Health Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06385405 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of personalized repetitive transcranial magnetic stimulation (TMS) based on electroencephalography (EEG) data for treating major depressive disorder (MDD). By utilizing machine learning techniques to analyze EEG data, the study aims to optimize TMS treatment to enhance symptom relief in patients. Participants will undergo clinical assessments and EEG parameter evaluations throughout the treatment process, which includes individualized TMS targeting the left dorsolateral prefrontal cortex. The study is conducted at the Shanghai Mental Health Center, a leading institution in mental health research.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 16-65 diagnosed with major depressive disorder who are willing to undergo neuromodulation therapy.
Not a fit: Patients with a history of electroconvulsive therapy, certain metal implants, epilepsy, pregnancy, or other specified mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and personalized treatment option for patients suffering from major depressive disorder.
How similar studies have performed: While the use of TMS for depression has been established, this study's personalized approach using EEG and machine learning is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The diagnosis of participants should be made in accordance to the diagnostic criteria described for Major Depressive Disorder (MDD) of the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V). * be willing to receive neuromodulation therapy and sign the written informed consent * an age of 16-65 years * The patient's medication regimen is based on only one antidepressant, and the medication regimen is not adjusted as much as possible during the treatment period. * Having a total score of not less than 20 on the Hamilton Depression Rating Scale (HAMD-24). * sufficient hearing or reading ability Exclusion Criteria: * History of electroconvulsive therapy (ECT) * Presence of metallic foreign bodies near the stimulation coil or stimulation scalp, e.g., intracranial metal implants, cochlear implants, built-in pulse generators (brain pacemakers, cardiac pacemakers) * Epilepsy * Pregnancy * History of head injury * Mental disorders such as schizophrenia, bipolar disorder, schizoid personality disorder, alcohol/drug abuse or dependence, etc. * Serious physical illnesses * Taking medication that lowers the seizure threshold * Participating in any clinical trial within 30 days before the baseline * Other situations judged by the investigators not to be suitable for the clinical trial
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: TianHong Zhang, Doctor — Shanghai Mental Health Center
- Study coordinator: TianHong Zhang, Doctor
- Email: zhang_tianhong@126.com
- Phone: 13127577024
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.