StimulUS: Transcranial Ultrasonic Stimulation in Treatment-resistant Depression : an Open-label Pilot Trial
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Transcranial Ultrasonic Stimulation with Personalized Acoustic Lens Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull |
Device: Transcranial Ultrasonic Stimulation prototype
Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation
|
Outcome Measures
Primary Outcome Measures
- Percent change in the Montgomery-Åsberg Depression Scale (MADRS) score from baseline to primary endpoint [Pre-treatment and Day 5 from start of intervention]
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.
Secondary Outcome Measures
- Incidence of serious adverse reactions according to the Common Terminology Criteria for Adverse Events (CTCAE) scale [Day 1 to Day 35 from start of intervention]
CTCAE are a set of criteria for the standardized classification of adverse effects
- Percent change in the Montgomery-Åsberg Depression Scale (MADRS) [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]
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.
- Percent change in the Hamilton Rating Scale for Depression (HDRS-17) [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]
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.
- Percent change in the Hamilton Rating Scale for Depression (HDRS-6) [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]
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.
- Percent change in the Inventory of Depressive Symptomatology (IDC-C) [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]
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.
- Percent change in the Quick Inventory of Depressive Symptomatology (QIDS-SR) [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]
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.
- Assess the changes in functional connectivity of sgACC after TUS [Pre-treatment and Day 7 from start of intervention]
Comparison of functional connectivity of subgenual cingulate cortex through resting state imaging analysis before / after intervention
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age between 18 and 75 years,
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Diagnosis of major depressive episode (MDE) as part of major depressive disorder as defined by DSM-5 criteria
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Severe MDE (HDRS-17> 20)
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Drug resistance to at least two well-conducted antidepressant treatment lines
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With stable antidepressant treatment for at least 4 weeks before inclusion
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Benefiting from a social security scheme
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Having given their consent to participate
Exclusion Criteria:
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Psychiatric history other than a mood disorder
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Neurological history, including epilepsy and intracerebral calcifications
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History of substance use disorder other than tobacco
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Contraindication to brain MRI (pacemaker, neurostimulator, injury from metallic shine, …)
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Compulsory psychiatric care
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Protected adults, people under legal safeguard
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Pregnant or breastfeeding woman
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Women of childbearing age who do not have a negative pregnancy test and are not using contraception
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GHU Sainte-Anne | Paris | France | 75014 |
Sponsors and Collaborators
- Centre Hospitalier St Anne
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D21-P020