The primary objective of this study is to optimize the protocol for the TUS administration in patients with TRD while gaining an initial impression of treatment efficacy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation
GHU Sainte-Anne
Paris, France
RECRUITINGPercent change in the Montgomery-Åsberg Depression Scale (MADRS) score from baseline to primary endpoint
MADRS is a ten item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.
Time frame: Pre-treatment and Day 5 from start of intervention
Incidence of serious adverse reactions according to the Common Terminology Criteria for Adverse Events (CTCAE) scale
CTCAE are a set of criteria for the standardized classification of adverse effects
Time frame: Day 1 to Day 35 from start of intervention
Percent change in the Montgomery-Åsberg Depression Scale (MADRS)
MADRS is a ten item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.
Time frame: Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention
Percent change in the Hamilton Rating Scale for Depression (HDRS-17)
HDRS-17 is a 17 item questionnaire used to score the severity of depression. Scale range - 0 to 52 with higher score indicative of greater depressive symptomology.
Time frame: Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention
Percent change in the Hamilton Rating Scale for Depression (HDRS-6)
HDRS-6 is a 6 item questionnaire used to score the severity of depression. Scale range - 0 to 22 with higher score indicative of greater depressive symptomology.
Time frame: Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention
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Percent change in the Inventory of Depressive Symptomatology (IDC-C)
IDS-C is a 30 item questionnaire used to score the severity of depression. Scale range - 0 to 90 with higher score indicative of greater depressive symptomology.
Time frame: Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention
Percent change in the Quick Inventory of Depressive Symptomatology (QIDS-SR)
QIDS-SR is a 16 item self-administered questionnaire used to score the severity of depression. Scale range - 0 to 27 with higher score indicative of greater depressive symptomology.
Time frame: Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention
Assess the changes in functional connectivity of sgACC after TUS
Comparison of functional connectivity of subgenual cingulate cortex through resting state imaging analysis before / after intervention
Time frame: Pre-treatment and Day 7 from start of intervention