An interventional study of Transcranial Magnetic Stimulation in Major Depressive Disorder, sponsored by University Hospital Tuebingen. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Treatment
Major depressive disorder (MDD) is a common severe psychiatric disease with enormous socioeconomic costs for the patient and society alike. Current pharmacological treatments are ineffective in a substantial fraction of patients and are accompanied by unwanted side effects. Using a novel non-invasive brain stimulation method to specifically target and modulate dysfunctional brain oscillations with high spatial and temporal precision this study will investigate the efficacy of EEG-triggered transcranial magnetic stimulation to alleviate de-pressive symptomatology in patients with MDD in a double-blind randomized controlled pilot clinical trial.
Evidence from rTMS in the motor system suggests that synchronization of the individual TMS pulses with the negative (in a reference-free Laplacian transform) peak of endogenous EEG-derived brain oscillations results in LTP-like increase in cortical excitability, with the negative peak corresponding to a high-excitability state. A previous proof-of-principle study (BOSSFRONT, funded in the "AKF Anreizprogramm") showed that this approach can be used in patients suffering from major depressive disorder. Recent data from our lab in healthy volunteers indicates that the negative peak of frontocentral theta oscillations may play a similar role in frontal networks, and was therefore chosen with a dorsomedial prefrontal stimulation target in this study aiming to demonstrate therapeutic efficacy of a brain-oscillation synchronized stimulation protocol. The study is a single-site randomized standard TMS therapy-controlled double-blind parallel-group design clinical trial comparing theta-synchronized rTMS over left DMPFC with standard iTBS over left DLPFC in 30 patients with MDD. The primary outcome measure of the study is the difference in MADRS change (baseline / end of treatment) between the two treatment arms.
2,806 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.
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Repetitive TMS (100 Hz triple pulses) of the dmPFC will be applied daily for four weeks (5 sessions per week on working days, 20 sessions in total). Stimulation triggers will be brain oscillation-synchronized based on EEG extracted over left dmPFC, synchronized with the negative peak of endogenous theta oscillations in left dmPFC.
Device: Transcranial Magnetic Stimulation
Standard intermittent Theta Burst Stimulation of the dlPFC will be applied daily for four weeks (5 sessions per week on working days, 20 sessions in total). Stimulation triggers will be applied independently of the EEG signal.
Device: Transcranial Magnetic Stimulation
Individually MR-neuronavigated TMS, 600 pulses, 120% RMT
Montgomery-Åsberg Depression Rating Scale (MADRS)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a questionnaire for external assessment of the severity of a depressive syndrome. The questionnaire consists of 10 questions. The questions are rated on a 7-point scale from 0 to 6. The total score ranges from 0 (best outcome) to 60 (worst outcome) points by summing up. The questionnaire is considered gold standard in the assessment of depressive symptoms. It will be performed at baseline and at the end of the treatment.
Time frame: baseline, immediately after the intervention
MADRS (Montgomery-Åsberg Depression Rating Scale) 4 weeks after intervention
Difference in MADRS change 4 weeks after the last treatment session vs. baseline measurement on the day of the first treatment session between the two treatment arms. The Montgomery-Åsberg Depression Rating Scale (MADRS) is a questionnaire for external assessment of the severity of a depressive syndrome. The questionnaire consists of 10 questions. The questions are rated on a 7-point scale from 0 to 6. The total score can be between 0 (best outcome) and 60 (worst outcome) after summing up. The questionnaire is considered gold standard in the assessment of depressive symptoms. It will be performed at baseline and at the end of the treatment.
Time frame: 4 weeks after the last interventional session
HDRS-17 (Hamilton Depression Rating Scale-17)
The HDRS-17 (Hamilton Depression Rating Scale-17) is designed to rate the severity of depression in patients. The rating is performed by a clinician. A score of 0-7 is considered to be normal while a score of 20 or higher indicates at least moderate severity.
Time frame: baseline, immediately after the intervention
BDI-2 (Beck Depression Inventory-2)
BDI-2 (Beck Depression Inventory-2) is a 21-question multiple-choice self-report inventory and represents the most widely used psychometric test for assessing the severity of depression in patients. 29-63 points reflect a severe depression.
Time frame: baseline, immediately after the intervention
IDS-30 (Inventory of depressive symptoms-30)
The IDS-30 (Inventory of depressive symptomes-30) is considered equivalent to or superior to the standard Hamilton Depression Scale (HAMD) and Beck Depression Inventory (BDI) tests. The scores ranges from 0 to 84 points. Patients with scores from 39 are considered severely depressed.
Time frame: baseline, immediately after the intervention
Response Rate
Response rate (50% reduction from MADRS) after the last treatment vs. measurement on the day of the first treatment session
Time frame: immediately after the intervention
Remission Rate
Remission rate (MADRS under 9 points) after the last treatment
Time frame: immediately after the intervention
Started Sep 2023 (actual). Primary completion is estimated for Aug 2025, 23 months after the start.
Of 612 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 23 months is below that.
Counting every sponsor, half of 652 studies reached it within 30 months; a quarter within 16 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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