NCT06345651

Brain Oscillation-synchronized Stimulation of the Frontal Cortex in Major Depressive Disorder

Brain Oscillation Synchronized Stimulation of the Frontal Cortex: Randomized Controlled Trial Comparing Frontal Theta-oscillation Synchronized Repetitive TMS With Standard TMS in Major Depressive Disorder

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Major depressive disorder (MDD) is a common severe psychiatric disease with enormous socioeconomic costs for the patient and society alike. Current pharmacological treatments are ineffective in a substantial fraction of patients and are accompanied by unwanted side effects. Using a novel non-invasive brain stimulation method to specifically target and modulate dysfunctional brain oscillations with high spatial and temporal precision this study will investigate the efficacy of EEG-triggered transcranial magnetic stimulation to alleviate de-pressive symptomatology in patients with MDD in a double-blind randomized controlled pilot clinical trial.

Detailed description

Evidence from rTMS in the motor system suggests that synchronization of the individual TMS pulses with the negative (in a reference-free Laplacian transform) peak of endogenous EEG-derived brain oscillations results in LTP-like increase in cortical excitability, with the negative peak corresponding to a high-excitability state. A previous proof-of-principle study (BOSSFRONT, funded in the "AKF Anreizprogramm") showed that this approach can be used in patients suffering from major depressive disorder. Recent data from our lab in healthy volunteers indicates that the negative peak of frontocentral theta oscillations may play a similar role in frontal networks, and was therefore chosen with a dorsomedial prefrontal stimulation target in this study aiming to demonstrate therapeutic efficacy of a brain-oscillation synchronized stimulation protocol. The study is a single-site randomized standard TMS therapy-controlled double-blind parallel-group design clinical trial comparing theta-synchronized rTMS over left DMPFC with standard iTBS over left DLPFC in 30 patients with MDD. The primary outcome measure of the study is the difference in MADRS change (baseline / end of treatment) between the two treatment arms.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Stimulation	Individually MR-neuronavigated TMS, 600 pulses, 120% RMT

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2024-04-03
• Last updated: 2024-04-03

Locations

1 site across 1 country: Germany