Repetitive Transcranial Magnetic stimulation (rTMS) is an FDA-approved therapy for treatment resistant depression (TRD) that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. But studies of rTMS alone show remission rates of \~30%. Additionally, rTMS has not been shown to improve cognitive functioning that may be an independent factor predicting treatment success. This study will develop a novel multimodal treatment, which combines intermittent theta burst stimulation (iTBS) - a type of rTMS with digital mindfulness training to engage brain plasticity, enhance cognition and alleviate depression symptoms in individuals with TRD.
Diagnosis of major depressive episode (MDE, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar major depressive disorder.
At least one failed antidepressant medication trial at level 3 in the Antidepressant -Treatment History Form: Short Form (ATHF-SF) classification.
Montgomery-Åsberg Depression Rating Scale (MADRS) Score >19 (moderate - severe depression).
No increase or initiation of new antidepressant therapy in the four weeks prior to screening.
Inability to provide informed consent.
Medically unstable patients.
Concomitant neurological disorder or a history of a seizure disorder.
Exhibiting current suicidal behavior rating on the Columbia Suicide Severity Rating Scale (C-SSRS)
Parallel
Medi-TBS
Combination productThe multimodal intervention involves combining FDA-approved repetitive transcranial magnetic stimulation (rTMS) with digital mindfulness exercises.
Change in EEG source localized pDMN alpha activity
EEG alpha band (8-12 Hz) activity source-localized to the posterior Default Mode Network (pDMN) brain region extracted on distracted trials of the Breath Attention Assessment of Mindfulness task serves as the primary neural target.
Change in Selective Attention
Processing speed of response to target stimuli on a standard continuous performance task that measures the ability to selectively attend and promptly respond to a goal-relevant target stimulus serves as the secondary cognitive target.
Change in Flanker Inhibition
Efficiency of inhibiting visuo-spatially flanking distractors to target stimuli in the Flanker task serves as the secondary cognitive target.
Change in Montgomery Åsberg Depression Rating Scale Scores (MADRS)
The MADRS will be used to evaluate % depressive symptom response defined as 50% change in the MADRS score from baseline as well as remission defined as MADRS score \<7 at post-intervention. Scale range: 0-54, higher score is worse depression.
Change in Working Memory
Span-weighted efficiency will be measured on a standard Delayed Match to Sample Task
Change in Mindful Attention Awareness Scale (MAAS)
The MAAS will be used to evaluate change in subjective state mindfulness. Scale range: 6-84, higher score is greater mindfulness
Change in Rumination Reflection Questionnaire (RRQ)
The RRQ will be used to evaluate change in subjective rumination. Scale range: 22-88, higher score is greater rumination
Change in Patient Health Questionnaire 9 item scale (PHQ9)
The PHQ9 scale will be used as an additional measure to evaluate change in depressive symptom response. Score range: 0-27, higher score is greater depression
Click on the lead sponsor to view all of their trials.
