NCT05212636

Using Repetitive Transcranial Magnetic Stimulation to Study the Role of Frontostriatal Circuit in Major Depressive Disorder

Completed NA Last updated 28 January 2022

What this trial tests

NA trial testing Repetitive transcranial magnetic stimulation (rTMS) in Depressive Disorder, Major in 20 participants. Completed in 31 October 2021.

Timeline

1 August 2020

Primary endpoint
28 October 2021

31 October 2021

Quick facts

Lead sponsor	National Cheng-Kung University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 August 2020
Primary completion	28 October 2021
Estimated completion	31 October 2021
Sites	1 location across Taiwan

Drugs / interventions tested

• Repetitive transcranial magnetic stimulation (rTMS)

Conditions studied

• Depressive Disorder, Major — all drugs for Depressive Disorder, Major →

Sponsor

National Cheng-Kung University Hospital

Who can join

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

Sponsor's own description

Major depressive disorder (MDD) is a common, severe, and often life-threatening illness that involves the body, mood, and thoughts. The natural course of MDD tends to worsen without treatment, while people with MDD can lead healthy and productive lives when the illness is effectively treated. Up to 50% of the patients show no response to current available antidepressants.Two major non-invasive brain stimulation (NIBS) tools have been applied for the treatment of psychiatric diseases so far, transcranial magnetic and direct current stimulation (TMS, tDCS). TMS induces a strong magnetic field (magnetic pulses) through the skull into the brain, which generates electrical currents in brain tissue and induces neuronal firing, leading to after-effects, i.e. neuroplasticity, eventually. Neuronal effects of rTMS has been proven to last beyond the actual time of stimulation, enabling altered brain activity for an extended period of time. Adding on rTMS treatment could even give a chance to treat the physical comorbidities and enhance cognitive function in MDD. Nevertheless, underlying neurobiological mechanism of rTMS treatment remains unclear. Reports showed chronic psychosocial stressors are associated with altered frontal-striatal circuitry activation and connectivity. Indeed, aberrant fronto-striatal connectivity and reduced sustain fronto-striatal activation were noticed in MDD patients. However, the specific correlations between fronto-striatal connectivity changes and rTMS treatment outcomes in MDD remain unclear. In this study fMRI will be used to measure the possible correlations between the fronto-striatal circuit activation / connectivity with (1) mood symptoms presentations, (2) neurocognitive measurements, (3) HPA and ANS activities, and (4) immune and metabolic status (cytokines, adipokines and insulin levels) in patients with MDD. Then the possible changes in fronto-striatal FC over a four-week treatment course with 10 Hz rTMS stimulation to left dorsolateral prefrontal cortex will be measured. The FC changes will be tested to find out whether correlate with treatment outcomes, HPA and ANS activity; and immune/metabolic indices changes.

We hypothesize that rTMS as an add-on therapy would change the fronto-striatal FC that correlated with mood symptom improvement, neurocognitive measurements, HPA and ANS activity, inflammatory and metabolic homeostasis in patients with MDD.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.