Department of Psychiatry and Psychotherapy
Budapest, Pest County, 1083, Hungary
NCT Number: NCT07207239
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Budapest, Pest County, 1083, Hungary
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 120 days
The primary outcome measures are the clinical symptoms of depression measured by a clinician with the Montgomery-Åsberg Depression Rating Scale.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 120 days
Beck depression inventories are to be used to monitor clinical symptoms of depression
Semmelweis University
Other
Acronym: TMS-DEP-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.
Published trials that share one or more normalized conditions with this study.
NCT04661904
Confusion, Delirium
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT06027190
Cranial Nerve Diseases, Deglutition Disorders
Nanjing, China
View Trial DetailsNCT02273063
Depressive Disorder, Depressive Disorder, Major
Providence, Rhode Island, United States
View Trial DetailsNCT07680140
Depression - Major Depressive Disorder, Depressive Disorder
New York, United States
View Trial Details