NCT05117983

Non-invasive Brain Stimulation Normalizes Dopaminergic Transmission in the Frontostriatal Circuit to Alleviate Depression With Metabolic Disorders.

Status unknown NA Last updated 11 November 2021

What this trial tests

NA trial testing Repetitive transcranial magnetic stimulation (rTMS) in Depression in 90 participants. Status unknown.

Timeline

12 August 2021

Primary endpoint
31 July 2024

31 July 2024

Quick facts

Lead sponsor	National Cheng-Kung University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	12 August 2021
Primary completion	31 July 2024
Estimated completion	31 July 2024
Sites	1 location across Taiwan

Drugs / interventions tested

• Repetitive transcranial magnetic stimulation (rTMS)

Conditions studied

• Depression — all drugs for Depression →

Sponsor

National Cheng-Kung University Hospital

Who can join

Adults 20 to 70, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Depression and metabolic disorder (MetD) are two of the most common and debilitating disorders worldwide, occurring with significant rates of comorbidity. This is a major clinical challenge as the outcomes of both conditions are worsened. Studies have uncovered that depression and metabolic disorder are associated with chronic, low-grade inflammation. In brain circuit level, patients with depression are characterized with aberrant frontostriatal (FS) circuit connectivity and reduced activity level that also associated with metabolic comorbidity. In neurotransmitter level, the dopaminergic pathway, that could be feedback regulated by immune and metabolic factors, has long been known to involve in emotional and metabolic homeostasis. More importantly, this dopamine (DA) input is critical to shaping the FS circuit-level dynamic connectivity and plasticity. Therefore, this study hypothesizes that inflammatory and metabolic dysregulations on DA transmission link to the aberrant FS function that cause mood and metabolic syndromes. To clarify the underlying mechanisms, 90 patients who meet the DSM-5 diagnostic criteria of major depressive episode in either major depressive disorder or bipolar disorder are planned to be recruit. FS functional connectivity and activation, before and after receiving 10 Hz repetitive transcranial magnetic stimulation (rTMS) to left dorsolateral prefrontal cortex will be measured. Then systemically analyze participants' clinical symptomology, neurocognitive function, inflammation and metabolic status. Possible correlations between indices, the effects of rTMS and differences between groups will be tested. Results could provide a chance for further understanding the pathophysiology of depression with MetD and comparing between unipolar and bipolar depression, and developing brain circuit based non-invasive brain stimulation personalized treatment for depression with MetD to achieve a better outcome.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.