Active rTMS over the left DLPFC and over the left DMPFCActive rTMS over the left DLPFCSham rTMS
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.
Active rTMS over the left DLPFC: Active rTMS over the left DLPFC to induce the long term potentiation of stimulated area.
Sham rTMS: Sham rTMS over the left DLPFC or over the left DLPFC and over the left DMPFC for placebo.
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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Beck Depression Inventory 2 — 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.
Froward digit span — 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.
Language part of Addenbrooke's Cognitive Examination — 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.
Trial sites (1)
Facility
City
Region
Status
The Education of Research and Development Center, Babinski Clinical Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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