Depression - Major Depressive Disorder, Transcranial Magnetic Stimulation, Repetitive
Conditions
Keywords
TMS, therapy resistant depression, EEG, MRI, neuroimaging
Brief summary
The primary aim of the study is to find the combination of neuroimaging-related markers, demographics, and clinical characteristics that predict the response of patients with therapy-resistant depression to theta-burst rTMS treatment. The secondary aim is to monitor the cognitive effects of TMS therapy.
Interventions
DEVICErepetative Transcranial Magnetic Stimulation (rTMS), theta-burst protocol
Theta-burst rTMS treatment stimulates the left Dorsolateral Prefrontal Cortex (DLPFC). The TBS parameters the investigators adopted follows the standard TBS protocols, with 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz) and an intensity of 100% active motor threshold. The investigators plan to deliver 1800 stimuli to the left DLPFC daily in 9.5-minute blocks for four weeks.
Sponsors
Semmelweis University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. diagnosis of depression 2. 18 years of age 3. Beck depression inventory score above 12 (screening) 4. MADRS score above 6 (baseline)
Exclusion criteria
1. serious cognitive impairment 2. mental retardation 3. history of head injury with loss of consciousness for more than 1 hour 4. alcohol or drug abuse within the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical symptoms | 120 days | The primary outcome measures are the clinical symptoms of depression measured by a clinician with the Montgomery-Åsberg Depression Rating Scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient profile | 120 days | The patient profile encompasses demographics and clinical characteristics, namely age, sex, level of education, history of other psychiatric conditions, comorbidities, and medications. Together with neuroimaging characteristics, these will be used for response prediction. |
| Cognitive functioning/Spatial working Memory | 120 days | The test will be used measure spatial working memory. Memory span is the major outcome variable of this test (the longest number of elements correctly retraced). Higher values indicate better outcomes. Its minimum value is 0 and it has no theoretical maximum value. |
| Neuroimaging characteristics | 120 days | A secondary outcome measure is neuroimaging characteristics including the alpha peaks measured by EEG, the nonoscillatory component (1/f) calculated from resting EEG, and connectivity parameters measured by fMRI. These markers will play a part in response prediction. |
| Cognitive functioning/reaction time | 120 days | The test will be used measure executive functioning and reaction time. Average reaction time is the major outcome variable of this test. Higher values indicate worse outcomes. |
| Clinical symptoms based on self-report questionnaires | 120 days | Beck depression inventories are to be used to monitor clinical symptoms of depression |
| Cognitive functioning/Executive function | 120 days | The test will be used measure executive functioning. Number of mistakes is the major outcome variable of this test (mistakes arise when subjects fail to differentiate a distractor from the continuous task). Higher values indicate worse outcomes. Its minimum value is 0 and it has no theoretical maximum value. Time Frame: 120 days |
Countries
Hungary
Outcome results
None listed