NCT06363981

Multisite rTMS for Mood, Cognitive Impairment and Other Symptoms of Depression

Multisite Repetitive Transcranial Magnetic Stimulation for Mood, Cognitive Impairment, Anhedonia and Disordered Sleep in Depressive Disorder

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Jakub Antczak · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. The aim of this study is to assess the effect of rTMS applied over two stimulation sites on cognitive impairment, anhedonia and sleep disorders in depression.

Detailed description

Depression is one of the most common and disabling disorders, affecting approximately three hundred million people worldwide. Depressive mood is the main symptom, but other symptoms like cognitive impairment, anhedonia or sleep disorders contribute significantly to patients suffering, decrease quality of life and may even lead to suicide attempt. While modern pharmacotherapy can significantly improve symptoms in many patients, still one third of patients remains drug-resistant. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method of inducing brain plasticity. Stimulation over the left and right dorsolateral prefrontal cortex (DLPFC) and possibly over several other areas can improve mood. Only few studies investigated the effect of rTMS on negative psychiatric symptoms, such as anhedonia, sleeplessness or cognitive impairment. In these trials, either the DLPFC or the dorsomedial prefrontal cortex (dmPFC) were stimulated and sometimes other areas such as the insular cortex. The aim of this study is to investigate if a stimulation over both sites (multi-site stimulation) has better therapeutic potential for depressed mood, cognitive impairment, anhedonia and sleep disorders than stimulation over DLPFC alone and placebo.

Conditions

• Unipolar Depression
• Bipolar Disorder

Interventions

Type	Name	Description
DEVICE	Active rTMS over the left DLPFC and over the left DMPFC	Active rTMS over the left DLPFC and over the left DMPFC to induce the long term potentiation of stimulated areas.
DEVICE	Active rTMS over the left DLPFC	Active rTMS over the left DLPFC to induce the long term potentiation of stimulated area.
DEVICE	Sham rTMS	Sham rTMS over the left DLPFC or over the left DLPFC and over the left DMPFC for placebo.

Timeline

• Start date: 2024-05-20
• Primary completion: 2026-12-01
• Completion: 2027-04-01
• First posted: 2024-04-12
• Last updated: 2024-10-15

Locations

1 site across 1 country: Poland