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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TUS - 5 min sessions, 5% duty cycle, 5 sessions/day (n=5) | Experimental | Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull. Sessions of 5 minutes at a 5% duty cycle, delivered 5 times per day for 5 days (25 sessions total). |
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| TUS - 40 min sessions, 5% duty cycle, 2 sessions/day (n=7) | Experimental | Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull. Sessions of 40 minutes at a 5% duty cycle, delivered 2 times per day for 5 days (10 sessions total). |
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| TUS - 40 min sessions, 1% duty cycle, increased acoustic power, 2 sessions/day (n=10) | Experimental | Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull. Sessions of 40 minutes at a 1% duty cycle with increased acoustic power, delivered 2 times per day for 5 days (10 sessions total). |
|
| TUS - 40 min sessions, 5% duty cycle, increased acoustic power, 2 sessions/day (n=10) | Experimental | Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull. Sessions of 40 minutes at a 5% duty cycle with increased acoustic power, delivered 2 times per day for 5 days (10 sessions total). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Ultrasonic Stimulation prototype | Device | Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent 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. | Pre-treatment and Day 5 from start of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 to Day 35 from start of intervention |
| Percent change in the Montgomery-Åsberg Depression Scale (MADRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marion PLAZE | Contact | +33 1 45 65 87 20 | m.plaze@ghu-paris.fr | |
| David ATTALI | Contact | d.attali@ghu-paris.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GHU Sainte-Anne | Recruiting | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40311843 | Result | Attali D, Tiennot T, Manuel TJ, Daniel M, Houdouin A, Annic P, Dizeux A, Haroche A, Dadi G, Henensal A, Moyal M, Le Berre A, Paolillo C, Charron S, Debacker C, Lui M, Lekcir S, Mancusi R, Gallarda T, Sharshar T, Sylla K, Oppenheim C, Cachia A, Tanter M, Aubry JF, Plaze M. Deep transcranial ultrasound stimulation using personalized acoustic metamaterials improves treatment-resistant depression in humans. Brain Stimul. 2025 May-Jun;18(3):1004-1014. doi: 10.1016/j.brs.2025.04.018. Epub 2025 Apr 29. |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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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. |
| 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. | 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. | 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 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. | 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. | 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 | Pre-treatment and Day 7 from start of intervention |