The Effect of Theta-burst Stimulation on Serum BDNF

Launched by TAIPEI CITY HOSPITAL · May 2, 2023

Keywords

ClinConnect Summary

**Trial Summary: The Effect of Theta-burst Stimulation on Serum BDNF in Gambling Disorder**

This clinical trial is looking at a treatment called theta burst stimulation, which is a type of brain stimulation that may help people with major depression. The main goal is to see if this treatment can change the levels of a protein in the blood called brain-derived neurotrophic factor (BDNF), which is important for brain health. Participants will be divided into two groups: one will receive the actual treatment, while the other will receive a placebo or "sham" treatment that looks the same but doesn’t have the active effect. Researchers will then compare the BDNF levels between these groups to understand if the stimulation has an impact.

To participate in this study, individuals must be between the ages of 20 and 65 and have been diagnosed with major depressive disorder. However, there are some important exclusions: people with certain severe mental health conditions, those with specific medical issues, or anyone who has a history of seizures may not be eligible. If you join the trial, you can expect to undergo 10 sessions of theta burst stimulation and will be monitored closely throughout the process. This research could help improve understanding of depression treatments and how they affect brain health. If you or someone you know is struggling with depression, this could be an opportunity to explore a potential new approach.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. age between 20 and 65 years;
• • 2. fulfilling the Diagnostic and Statistical Manual version 5 (DSM-5) criteria of Major depressive disorder assessed by the Structured Clinical Interview
• Exclusion Criteria:
• • 1. Inability to provide informed consent or comprehend the study procedure;
• • 2. A major psychiatric illness including schizophrenia spectrum disorder, bipolar spectrum disorder, and major depressive disorder with psychotic features.
• • 3. A current DSM-5 diagnosis of substance use disorder except nicotine use disorder or the use of one to two low-potency benzodiazepine tablets for sleep impairment;
• • 4. Have known preexisting noise-induced hearing loss, concurrent treatment with ototoxic medications, or with cochlear implants.
• • 5. Unstable medical illness, including malignancy, uncontrolled diabetes mellitus, unstable cardiac disease or recent myocardial infarction, or cerebrovascular or cardiovascular risk factors that require intensive medical management
• • 6. On medications known to lower seizure threshold (e.g., TCA, bupropion, clozapine)
• • 7. Implants controlled by physiological signals, including pacemaker, implantable cardioverter defibrillator, cochlear implant.
• • 8. Metallic objects in the head, including stenting, suture.
• • 9. Elevated risk of seizure due to traumatic brain history, seizure history, and head trauma, intracranial lesion, and alcohol or benzodiazepines withdrawal syndrome, stimulant intoxication.