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This study aims to investigate the effects of individualized repetitive transcranial magnetic stimulation (rTMS) of parieto-hippocampal functional connectivity in patients with major depressive disorder (MDD). Specifically, patients will be randomized to one of three groups and will receive 15 days of rTMS over three weeks. Each day they will receive one active session of rTMS over the dorsolateral parietal cortex (DLPFC) and depending on group assignment another session either A) active rTMS over DLPFC, B) active rTMS over left and right lateral parietal cortex (LPC), or C) sham rTMS over DLPFC or LPC. Stimulation targets in the LPC will be individualized for each patient based on their resting-state functional connectivity between the hippocampus and LPC. Clinical, neuropsychological and fMRI data will be acquired before and after the treatment course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLPFC-DLPFC | Active Comparator | 15 sessions of active rTMS over DLPFC + 15 sessions of active rTMS over DLPFC |
|
| DLPFC-LPC | Experimental | 15 sessions of active rTMS over DLPFC + 15 sessions of active rTMS over LPC |
|
| DLPFC-SHAM | Sham Comparator | 15 sessions of active rTMS over DLPFC + 15 sessions of sham rTMS over DLPFC or LPC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active rTMS over DLPFC | Device | 15 sessions of active rTMS over DLPFC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression severity as measured by the Hamilton Depression Rating Scale (HAMD-17) | Remission defined as HAMD-17 score (range: 0 to 52, lower scores represent better outcome) of less than or equal to 8 after the rTMS course. Response defined as a reduction of at least 50% from baseline in HAMD-17 score after treatment. | Four measurement time points with a seven-day interval starting on the first day of stimulation, and ending three days after the last day of stimulation |
| Change in functional connectivity coefficients based on resting-state fMRI | Seed-to-voxel and ROI-to-ROI functional connectivity analysis of rs-fMRI data. | 3 days prior to first rTMS session and 3 days after last rTMS session |
| Change in task-based fMRI activation during associative memory paradigm | Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal encoding and retrieval with a focus on hippocampal regions. | 3 days prior to first rTMS session and 3 days after last rTMS session |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression severity as measured by the Beck's Depression Inventory (BDI-II) | Remission defined as BDI-II score (range: 0 to 63, lower scores represent better outcome) of less than or equal to 12 after the rTMS course. Response defined as a reduction of at least 50% from baseline in BDI-II score after treatment. | 3 days prior to first rTMS session and 3 days after last rTMS session, follow-up after 4, 8 and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| René Hurlemann, Prof. | University Hospital, Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik und Poliklinik für Psychiatrie und Psychotherapie | Bonn | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22658708 | Background | Fox MD, Buckner RL, White MP, Greicius MD, Pascual-Leone A. Efficacy of transcranial magnetic stimulation targets for depression is related to intrinsic functional connectivity with the subgenual cingulate. Biol Psychiatry. 2012 Oct 1;72(7):595-603. doi: 10.1016/j.biopsych.2012.04.028. Epub 2012 Jun 1. | |
| 25170153 | Background |
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| Add-on active rTMS over DLPFC | Device | 15 additional sessions of active rTMS over DLPFC |
|
| Add-on active rTMS over LPC | Device | 15 additional sessions of active rTMS over LPC |
|
| Add-on sham rTMS | Device | 15 additional sessions of sham rTMS over DLPFC or LPC |
|
| Change in visual memory as assessed by the Delayed Matching to Sample test (DMS) | Subjects will be assessed in the domain of visual memory by undergoing computorized neurological testing. Outcome varible is percentage of correct answers. | 3 days prior to first rTMS session and 3 days after last rTMS session |
| Change in spatial planning as assessed by the One Touch Stockings of Cambridge (OTS) | Subjects will be assessed in the domain of spatial planning by undergoing computorized neurological testing. Outcome varible is the mean number of choices to correct answer. | 3 days prior to first rTMS session and 3 days after last rTMS session |
| Change in visual sustained attention as assessed by the Rapid Visual Information Processing (RVP) | Subjects will be assessed in the domain of visual sustained attention by undergoing computorized neurological testing. Outcome varible is the target sensitivity A'. | 3 days prior to first rTMS session and 3 days after last rTMS session |
| Change in working memory as assessed by the Spatial Working Memory (SWM) | Subjects will be assessed in the domain of working memory by undergoing computorized neurological testing. Outcome varible is the total number of errors. | 3 days prior to first rTMS session and 3 days after last rTMS session |
| Change in task-based fMRI activation during social touch paradigm | Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal while participants receive tactile stimulation. | 3 days prior to first rTMS session and 3 days after last rTMS session |
| Change in task-based fMRI activation during emotional processing paradigm | Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal while participants perform an emotional processing task. | 3 days prior to first rTMS session and 3 days after last rTMS session |
| Wang JX, Rogers LM, Gross EZ, Ryals AJ, Dokucu ME, Brandstatt KL, Hermiller MS, Voss JL. Targeted enhancement of cortical-hippocampal brain networks and associative memory. Science. 2014 Aug 29;345(6200):1054-7. doi: 10.1126/science.1252900. |
| 29726344 | Background | Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26. |
| 25034472 | Background | Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5. |
| 15372137 | Background | Daumann J, Fischermann T, Heekeren K, Henke K, Thron A, Gouzoulis-Mayfrank E. Memory-related hippocampal dysfunction in poly-drug ecstasy (3,4-methylenedioxymethamphetamine) users. Psychopharmacology (Berl). 2005 Aug;180(4):607-11. doi: 10.1007/s00213-004-2002-8. Epub 2005 Sep 14. |
| ID | Term |
|---|---|
| D003863 | Depression |
| D003866 | Depressive Disorder |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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