The CogniTReaD study is a pilot clinical trial that will compare the effects of active accelerated bilateral sequential theta burst stimulation (absTBS) and sham or inactive treatment. The goal is to see if absTBS can help older adults with treatment-resistant depression (TRD) by looking at dual-task cost and mood, as well as other cognitive functions, anxiety levels, quality of life, and physical performance, while also checking for any treatment side effects. The study will recruit participants who will receive different study treatments in a specific order. The study will be double-blinded, meaning neither the participants nor the researchers will know who is receiving which treatment. The study will include people who are 50 years old or older and diagnosed with treatment-resistant depression with at least a moderate severity of depression. This study seeks to discover if absTBS can modify a dementia risk marker (i.e., dual-task cost and depression) in older patients with TRD, and to determine the effect size for larger investigations in the future.
The CogniTReaD study is a two-arm, sham-controlled, double-blinded, treatment-sequenced, randomized clinical trial that will evaluate and explore the effects and safety of accelerated bilateral sequential theta burst stimulation (absTBS) compared to sham control in terms of improving dual-task cost, cognitive functions, depression, other outcomes (anxiety, health-related quality of life, activities of daily living, global impression, and other gait performance), and occurrence of adverse events (AE) measured at Week 2 (i.e., posttreatment acute effects) in older adults with treatment-resistant depression (TRD). We shall also evaluate the effects and safety of absTBS on improving dual-task cost, cognitive functions, depression and occurrence of AE in terms of AE occurrences measured at Week 6, Week 8, and Week 10 (i.e., posttreatment delayed effects) in older adults with TRD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
We shall use the Magpro device (Magventure) employing the specialized Active/Sham B70 coil. absTBS shall be administered consisting of 6 sessions daily (with a 50-minute interval between treatment sessions) on Mondays to Fridays or for a maximum of 5 working days of daily treatment. The target stimulation intensity will be set at 90 to 120% of the subject's resting motor threshold (RMT). Each session shall be composed of administration of continuous theta burst stimulation (triplet burst pulses at 50 Hz, repeated at 5 Hz, for a total of 600 pulses per session over 40 seconds administered on the right dorsolateral prefrontal cortex) and then intermittent theta burst stimulation (triplet burst pulses at 50 Hz bursts, repeated at 5 Hz, 2 s on and 8 s off, for a total of 600 pulses per session over about 3 min, administered on the left dorsolateral prefrontal cortex). The sham treatment will be conducted for the same number of sessions and duration as the absTBS treatment sessions.
Ontario Shores Centre for Mental Health Sciences
Toronto, Ontario, Canada
RECRUITINGChange in Dual-task Cost
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Hamilton Depression Rating Scale 17 (HAMD-17) score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Adverse events (AE)
An AE is defined as any untoward medical occurrence associated with any of the study interventions (active absTBS or sham) whether or not considered related to the study intervention. A serious AE to any serious and unforeseen occurrence related or possibly related to the participation in the study that can lead to hospitalization, disability, or death.
Time frame: Week 1, Week 2, Week 3, Week 6, Week 8, and Week 10
Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) plus modalities score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Trail Making A (TMT-A) score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Trail Making B (TMT-B) score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Digit Symbol Substitution Test (DSST) score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Digit Span Forward (DSF) score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Digit Span Backward (DSB) score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Category Verbal Fluency (CVF) score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Montreal Cognitive Assessment (MoCA) score
Time frame: Week 0 (baseline), Week 2
Change in Colour Word Interference Test (CWIT) score
Time frame: Week 0 (baseline), Week 2
Change in Patient Health Questionnaire-9 (PHQ-9) score
Time frame: Week 0 (baseline), Week 2
Change in Geriatric Depression Scale 30 (GDS-30) score
Time frame: Week 0 (baseline), Week 2
Change in Generalized Anxiety Disorder 7 (GAD-7) score
Time frame: Week 0 (baseline), Week 2
Change in Short Form 36 (SF-36) score
Time frame: Week 0 (baseline), Week 2
Change in Alzheimer Disease Cooperative Study - Activities of Daily Living inventory (ADCS-ADL) score
Time frame: Week 0 (baseline), Week 2
Change in Lawton-Brody Instrumental Activities of Daily Living (LB-IADL) score
Time frame: Week 0 (baseline), Week 2
Change in Clinical Global Impression (CGI) score
Time frame: Week 0 (baseline), Week 2
Change in Short Physical Performance Battery (SPPB) score
Time frame: Week 0 (baseline), Week 2
Change in Timed Up & Go (TUG) score
Time frame: Week 0 (baseline), Week 2
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