Clinical trial NCT04081519: Stimulation of Parieto-hippocampal Connectivity in Patients With Major Depressive Disorder
Official title: Stimulation of Parieto-hippocampal Connectivity in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depressive Disorder
Depressive Episode
Depressive Disorder, Major
Keywords: Repetitive Transcranial Magnetic Stimulation
Theta Burst Stimulation
rTMS
TBS
resting-state fMRI
functional connectivity
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
Collaborators: name: Clemens Mielacher, University Hospital, Bonn
First posted: 2019-09-09
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* fulfilled criteria for unipolar major depressive disorder for at least four weeks
* did not respond to a minimum of one or did not tolerate a minimum of two antidepressants in the current episode

Exclusion Criteria:

* metal in the brain or the skull
* cardiac pacemaker or intracardiac lines
* medication infusion devices
* heart or brain surgery
* pregnancy
* substance induced depression
* history of substance abuse
* psychotic episodes
* bipolar disorder
* anorexia
* posttraumatic stress disorder (current or within the last 12 months)
* claustrophobia
* any condition resulting in increased intracranial pressure
* traumatic brain injury
* history of epilepsy
* cerebral aneurysms
* dementia
* Morbus Parkinson
* Chorea Huntington
* multiple sclerosis
* stroke or transient ischemic attack (within the last 2 years)
* previous antidepressive treatment with rTMS, electroconvulsive therapy (within the last 3 months), vagus nerve stimulation or deep brain stimulation

Primary outcomes:
measure: Change in depression severity as measured by the Hamilton Depression Rating Scale (HAMD-17)
timeFrame: 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
measure: Change in functional connectivity coefficients based on resting-state fMRI
timeFrame: 3 days prior to first rTMS session and 3 days after last rTMS session
measure: Change in task-based fMRI activation during associative memory paradigm
timeFrame: 3 days prior to first rTMS session and 3 days after last rTMS session
Secondary outcomes:
measure: Change in depression severity as measured by the Beck's Depression Inventory (BDI-II)
timeFrame: 3 days prior to first rTMS session and 3 days after last rTMS session, follow-up after 4, 8 and 12 weeks
measure: Change in visual memory as assessed by the Delayed Matching to Sample test (DMS)
timeFrame: 3 days prior to first rTMS session and 3 days after last rTMS session
measure: Change in spatial planning as assessed by the One Touch Stockings of Cambridge (OTS)
timeFrame: 3 days prior to first rTMS session and 3 days after last rTMS session
measure: Change in visual sustained attention as assessed by the Rapid Visual Information Processing (RVP)
timeFrame: 3 days prior to first rTMS session and 3 days after last rTMS session
measure: Change in working memory as assessed by the Spatial Working Memory (SWM)
timeFrame: 3 days prior to first rTMS session and 3 days after last rTMS session
measure: Change in task-based fMRI activation during social touch paradigm
timeFrame: 3 days prior to first rTMS session and 3 days after last rTMS session
measure: Change in task-based fMRI activation during emotional processing paradigm
timeFrame: 3 days prior to first rTMS session and 3 days after last rTMS session
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Klinik und Poliklinik für Psychiatrie und Psychotherapie
Study officials:
affiliation: University Hospital, Bonn
name: René Hurlemann, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
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