Accelerated brain stimulation for treating depression
Accelerated iTBS for Depression: Monitoring Brain Hemodynamics With Simultaneous iTBS/fNIRS
This study is testing a new type of brain stimulation to see if it can help people with major depression who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06971549 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of accelerated theta-burst stimulation (iTBS) on patients with major depressive disorder by monitoring brain hemodynamics using functional near-infrared spectroscopy (fNIRS). Participants will undergo a series of iTBS sessions delivered over five consecutive days, with assessments of their depression symptoms before and after treatment. The aim is to understand the variability in cortical hemodynamic responses during the treatment process. The study focuses on patients who have not responded to previous antidepressant medications and have not received TMS treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with a clinical diagnosis of major depressive disorder who have not responded to at least one antidepressant.
Not a fit: Patients with severe internal diseases, neurological disorders, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients suffering from depression who have not responded to traditional therapies.
How similar studies have performed: While the approach of using accelerated iTBS is relatively novel, similar studies have shown promise in the use of TMS for treating depression.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged 18 to 65; * a clinical diagnosis of current nonpsychotic major depressive disorder by an experienced psychiatrist according to DSM-IV; * no or stable (≥2 weeks) psychopharmacological medication; * have not responded to at least one antidepressant medication; * have not received any TMS treatment; * and have a 17-item HAMD score ≥ 20. Exclusion Criteria: * severe internal diseases; * neurological disorders or a history of severe head injuries; * having suicidal ideation; * pregnancy; * common MRI, fNIRS and TMS exclusion criteria, such as a history of brain surgery, head injury, cardiac pacemaker, deep brain stimulation, intracranial metallic particles, history of seizures * antiepileptics and benzodiazepines corresponding to a dose of \>1 mg lorazepam/d.
Where this trial is running
Hong Kong
- The Hong Kong Polytechnic University — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Georg Kranz, PhD — The Hong Kong Polytechnic University
- Study coordinator: Georg Kranz, PhD
- Email: georg.kranz@polyu.edu.hk
- Phone: 27664838
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.