Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Andrzej Frycz Modrzewski Krakow University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS over the left DLPFC and over the left DMPFC | Experimental | Active 10 Herz rTMS with intensity of 120% of the resting motor threshold recorded from the right first dorsal interosseus and the right abductor hallucis will be administered over the left DLPFC and over the left DMPFC respectively. Therapy will include 20 sessions (one session in each of 20 consecutive working days - four weeks in total). In every session ca 1500 magnetic pulses over the left DLPFC and ca 1500 over the left DMPFC will be elicited. |
|
| rTMS over the left DLPFC | Active Comparator | Active 10 Herz rTMS with intensity of 120% of the resting motor threshold recorded from the right first dorsal interosseus will be administered over the left DLPFC. Therapy will include 20 sessions (one session in each of 20 consecutive working days - four weeks in total). In every session 3000 magnetic pulses over the left DLPFC will be elicited. |
|
| Sham rTMS | Sham Comparator | Sham 10 Herz rTMS will be administered over the left DLPFC. Therapy will include 20 sessions (one session in each of 20 consecutive working days - four weeks in total). In every session 3000 magnetic pulses over the left DLPFC or ca 1500 magnetic pulses over the left DLPFC and ca 1500 over the left DMPFC will be elicited. (rTMS protocol will be chosen randomly before the first session). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory 2 | 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. | Before intervention - four weeks after finishing intervention. |
| Froward digit span | 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. | Before intervention - four weeks after finishing intervention. |
| Language part of Addenbrooke's Cognitive Examination | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dimensional Anhedonia Rating Scale | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wojciech Korzeniowski, MD | Contact | +48 12 652 45 20 | wojciech.korzen@gmail.com | |
| Jakub Antczak, MD | Contact | +48 12 400 25 50 | jakub.antczak@uj.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Wojciech Korzeniowski, MD | The Education of Research and Development Center, Babinski Clinical Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Education of Research and Development Center, Babinski Clinical Hospital | Recruiting | Krakow | 30393 | Poland |
Scans of scales, inventories and questionnaires will be available upon request sent per e-mail to: wojciech.korzen@gmail.com
December 2026 - December 2030
For researchers in medical sciences and medical professional upon justification of their request.
Not provided
Not provided
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| D060825 | Cognitive Dysfunction |
| D059445 | Anhedonia |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
Parallel Assignment Prospective, randomized, sham-controlled clinical trial in parallel design
Not provided
Not provided
Placebo intervention will be delivered with a programmable coil for magnetic stimulation, which can be switched by a third person between modes of active (therapeutic) and sham stimulation. In the sham-mode coil elicits similar sounds as in the active stimulation, but induces only negligible magnetic field.
| 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. |
|
| Before intervention - four weeks after finishing intervention. |
| Before intervention - four weeks after finishing intervention. |
| Athens Insomnia Scale | 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. | Before intervention - four weeks after finishing intervention. |
| Pittsburgh Sleep Quality Index | 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. | Before intervention - four weeks after finishing intervention. |
| Epworth Sleepiness Scale | 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. | Before intervention - four weeks after finishing intervention. |
| D001519 |
| Behavior |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |