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NCT Number: NCT06363981

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active rTMS over the left DLPFC and over the left DMPFC

Device

Active rTMS over the left DLPFC and over the left DMPFC to induce the long term potentiation of stimulated areas.

Active rTMS over the left DLPFC

Device

Active rTMS over the left DLPFC to induce the long term potentiation of stimulated area.

sham rTMS

Device

Sham rTMS over the left DLPFC or over the left DLPFC and over the left DMPFC for placebo.

Primary outcomes

  1. Beck Depression Inventory 2

    Time frame: Before intervention - four weeks after finishing intervention.

    Inventory consisting of 21 items measuring cognitive, affective, somatic, and vegetative symptoms of depression. Each item is scored from 0 to 3, with a higher score denoting more severe depression. Items are related to the criteria from the Diagnostic and Statistical Manual of Mental Disorders-IV. The minimum value of the total score is 0 and the maximum is 63 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.

  2. Froward digit span

    Time frame: Before intervention - four weeks after finishing intervention.

    A measure of verbal short term and working memory. Participant is asked to repeat the random series of numbers, which become longer along with every correctly repeated one. Test is finished after participant failed to respond correctly on three occasions. The number of correctly repeated series determines the final score, which is an integer representing the length of the largest passed sequence. The scores range from 3 to 9 with higher scores denoting better outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.

  3. Language part of Addenbrooke's Cognitive Examination

    Time frame: Before intervention - four weeks after finishing intervention.

    A test to identify cognitive impairment in dementia. In the language part, participant is asked to complete a set commands such as "place the paper on top of the pencil"; to write grammatically-complete sentences; to repeat several words and proverbs; to name the objects shown in drawings, and answer questions and to read several mispronounced words. The number of correctly completed tasks is scored. The minimum value of the total score is 0 and the maximum (of the language part) is 26 with higher scores meaning better outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.

Secondary outcomes

  1. Dimensional Anhedonia Rating Scale

    Time frame: Before intervention - four weeks after finishing intervention.

    A 17-item scale that measures desire, motivation, effort and consummatory pleasure across hedonic domains. In each item, participant chooses one of four statements describing his attitude towards a given activity. The minimum value of the total score is 0 and the maximum is 68 with higher scores meaning better outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.

  2. Athens Insomnia Scale

    Time frame: Before intervention - four weeks after finishing intervention.

    An eight item scale. Each item is rated from 0 to 3 with higher scores representing more severe insomnia. Change from baseline score in the Athens Insomnia Scale to the measurement taken after finishing rTMS. The minimum value of the total score is 0 and the maximum is 24 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.

  3. Pittsburgh Sleep Quality Index

    Time frame: Before intervention - four weeks after finishing intervention.

    Pittsburgh Sleep Quality Index (PSQI) is a questionnaire to identify sleep disturbances. It consists of a combination of Likert-type and open-ended questions, which are later converted to scaled scores. Scores for each question range from 0 to 3. The minimum value of the total score is 0 and the maximum is 21 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.

  4. Epworth Sleepiness Scale

    Time frame: Before intervention - four weeks after finishing intervention.

    An eight-item scale. Each item refers to a situation such as driving a car or sitting quietly. The subject is asked to assess the chance of dosing in each situation, ranging from 0 (no chance) to 3 (dosing very likely). The minimum value of the total score is 0 and the maximum is 24 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Jakub Antczak, MD

CONTACT

[email protected]

+48 12 400 25 50

Wojciech Korzeniowski, MD

CONTACT

[email protected]

+48 12 652 45 20

Sponsors and collaborators

Lead sponsor

Jakub Antczak

Other

Collaborators

  • Andrzej Frycz Modrzewski Krakow University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 12, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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