Clinical Trial

Randomized Controlled Trial Testing the Efficacy of Transcranial Magnetic Stimulation by Accelerated & High-dose Theta-burst, Functional Imaging Guided, in the Treatment of Depression in Elderly Subjects With Cognitive Impairment

Study acronym: OLDEP-TBS
Not Yet Recruiting
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Summary
This trial aims at testing a new intensive, personalized functional targeting, transcranial magnetic stimulation technique for elderly patients (aged ≥ 65 years) suffering from a current treatment resistant depressive episode to at least one antidepressant, and suffering from significant secondary cognitive impairment. The intervention will be based on an accelerated neuromodulation technique using intermittent theta bursts (aiTBS) guided by a personalised funcitonal target within the left dorsolateral prefrontal cortex (DLPFC), using the SAINT® technology, which was recently cleared by the FDA.
Trial Details
NCT Number NCT07188753
Lead Sponsor Rennes University Hospital
Conditions Treatment Resistant Depression, Elderly Depression (≥65y.o.)
Enrollment 186 participants
Start Date 2025-12-15
Primary Completion 2031-06-15 (estimated)
Study Completion 2031-12-15 (estimated)
Updated on ClinicalTrials.gov 2025-09-23