Randomized Controlled Trial Testing the Efficacy of Transcranial Magnetic Stimulation by Accelera… (NCT07188753) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
186 participantsStarted 2025-12-15
Plain-language 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.
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. Male or female, of ages ≥ 65 years at the time of screening
✓. Currently diagnosed with either Major Depressive Disorder (MDD) and meets criteria for a current Major Depressive Episode (MDE) according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).
✓. Patients that don't meet the treatment response criteria according to antidepressant treatment history form (ATHF) for whom a switch to another ATD is required.
✓. rTMS/iTBS naïve.
✓. Access to ongoing psychiatric care before and after completion of the study.
✓. Access to clinical rTMS after completion of the study.
✓. In good general health, as evidenced by medical history (i.e. any ongoing serious and vital medical condition).
✓. Having signed a free, informed and written consent
Exclusion criteria
✕. Major cognitive disorder according to DSM-5 criteria.
What they're measuring
1
To determine the effect of aiTBS, as compared to sham stimulation, on depressive symptoms at one-month visit (35+/-3 days after the last day of treatment).
Timeframe: at one-month visit (35+/-3 days after the last day of treatment)