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Recruiting NCT06363981

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

No phase Interventional Unipolar Depression Bipolar Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active rTMS over the left DLPFC and over the left DMPFC, Active rTMS over the left DLPFC, Sham rTMS.
Who it may be relevant to
Registry conditions: Unipolar Depression, Bipolar Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Beck Depression Inventory 2 [Time frame: Before intervention - four weeks after finishing intervention.]
  • Froward digit span [Time frame: Before intervention - four weeks after finishing intervention.]
  • Language part of Addenbrooke's Cognitive Examination [Time frame: Before intervention - four weeks after finishing intervention.]
Secondary outcome measures (4)
  • Dimensional Anhedonia Rating Scale [Time frame: Before intervention - four weeks after finishing intervention.]
  • Athens Insomnia Scale [Time frame: Before intervention - four weeks after finishing intervention.]
  • Pittsburgh Sleep Quality Index [Time frame: Before intervention - four weeks after finishing intervention.]
  • Epworth Sleepiness Scale [Time frame: Before intervention - four weeks after finishing intervention.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Poland · 1 center
  • The Education of Research and Development Center, Babinski Clinical Hospital — Krakow

Identifiers

NCT: NCT06363981 · JagiellonianU72

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗