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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorRennes University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • transcranial magnetic stimulation by accelerated & high-dose theta-burst, functional imaging guided, i

Treatment groups

186 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators