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

Last updated: October 9, 2024
Sponsor: Jakub Antczak
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Bipolar Disorder

Dementia

Treatment

Active rTMS over the left DLPFC and over the left DMPFC

Sham rTMS

Active rTMS over the left DLPFC

Clinical Study ID

NCT06363981
JagiellonianU72
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • severe or moderate depressive episode (according to international classification ofdiseases (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 DepressionsInventory 2

  • Complaining about problems with memory and concentration timely related with theonset of depression

Exclusion

Exclusion Criteria:

  • Contraindications to transcranial magnetic stimulation, including ferromagneticelements 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

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: Active rTMS over the left DLPFC and over the left DMPFC
Phase:
Study Start date:
May 20, 2024
Estimated Completion Date:
April 30, 2027

Study 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.

Connect with a study center

  • The Education of Research and Development Center, Babinski Clinical Hospital

    Cracovia, 30393
    Poland

    Active - Recruiting

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