RecruitingRecruiting
Multisite rTMS for Mood, Cognitive Impairment and Other Symptoms of Depression
NCT06363981 · Jagiellonian University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Multisite Repetitive Transcranial Magnetic Stimulation for Mood, Cognitive Impairment, Anhedonia and Disordered Sleep in Depressive Disorder
About this study
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.
Eligibility criteria
Inclusion Criteria:
* severe or moderate depressive episode (according to international classification of diseases (ICD)-10) without psychotic symptoms at the time of inclusion
* Hamilton Depression Rating Scale between between 20 and 35 points at inclusion
* The score in the Athens Insomnia Scale eight or more
* The score of three or more points in items 4 and 21 of the Beck Depressions Inventory 2
* Complaining about problems with memory and concentration timely related with the onset of depression
Exclusion Criteria:
* Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy
* Psychotic symptoms at the time of inclusion
* Suicidal ideations and/or attempts within three months prior to inclusion
Study design
Enrollment target: 90 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-05-20
Estimated completion: 2027-04
Last updated: 2024-10-15
Interventions
Device: Active rTMS over the left DLPFC and over the left DMPFCDevice: Active rTMS over the left DLPFCDevice: Sham rTMS
Primary outcomes
- • Beck Depression Inventory 2 (Before intervention - four weeks after finishing intervention.)
- • Froward digit span (Before intervention - four weeks after finishing intervention.)
- • Language part of Addenbrooke's Cognitive Examination (Before intervention - four weeks after finishing intervention.)
Sponsor
Jakub Antczak · other
With: Andrzej Frycz Modrzewski Krakow University
Contacts & investigators
ContactWojciech Korzeniowski, MD · contact · wojciech.korzen@gmail.com · +48 12 652 45 20
ContactJakub Antczak, MD · contact · jakub.antczak@uj.edu.pl · +48 12 400 25 50
InvestigatorWojciech Korzeniowski, MD · principal_investigator, The Education of Research and Development Center, Babinski Clinical Hospital
All locations (1)
The Education of Research and Development Center, Babinski Clinical HospitalRecruiting
Krakow, Poland