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.
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.
Major cognitive disorder according to DSM-5 criteria.
The presence or diagnosis of prominent (primary) anxiety disorder, personality disorder, or dysthymia.
Bipolar Affective Disorder I & II and primary psychotic disorders.
Autism Spectrum disorder or Intellectual Disability.
Parallel
transcranial magnetic stimulation by accelerated & high-dose theta-burst, functional imaging guided, i
Other interventionParticipants will then be treated with 1,800 pulses of iTBS (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds) per session at 90% resting motor threshold and depth-adjustment to the personalized functional target. Each session will last 10 min followed by a 50-minute intersession interval. Ten sessions will be applied per day (18,000 pulses/day) for 5 consecutive days (90,000 total pulses).
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).
Montgomery and Asberg Depression Rating Scale (MADRS) (min:0 / max:60)
To determine the effect of aiTBS, as compared to sham stimulation on depressive symptoms at two-month post-intervention
Montgomery and Asberg Depression Rating Scale (MADRS) (min:0 / max:60)
To determine the effect of aiTBS, as compared to sham stimulation
Montgomery and Asberg Depression Rating Scale (MADRS) (min:0 / max:60)
To determine the effect of aiTBS, as compared to sham stimulation
MATTIS (global cognitive functioning) score
To determine the effect of aiTBS, as compared to sham stimulation
MATTIS (global cognitive functioning) score
To determine the effect of aiTBS, as compared to sham stimulation on depressive symptoms at immediate post visit
Montgomery and Asberg Depression Rating Scale (MADRS) (min:0 / max:60)
To determine the effect of aiTBS, as compared to sham stimulation on factors associated with treatment resistance at immediate, one-month, two-month, and six-month post-intervention in depression and suicide risk - such as anhedonia
SHAPS - clinician rated (anhedonia scale) score (min:0 / max:14)
To determine the effect of aiTBS, as compared to sham stimulation on factors associated with treatment resistance at immediate, one-month, two-month, and six-month post-intervention in mental pain, loneliness
Visual Analogic Scale for Mental Pain (VAS-MP) (min: 0 =smallest possible - max:10 = largest possible)
To determine the effect of aiTBS, as compared to sham stimulation on factors associated with treatment resistance at immediate, one-month, two-month, and six-month post-intervention in oneliness
BHS (hopelessness) (min:0 / max:20)
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