Transcranial Ultrasonic Stimulation in Treatment-resistant Depression : an Open-label Pilot Trial
- Conditions
- Treatment Resistant Depression
- Interventions
- Device: Transcranial Ultrasonic Stimulation prototype
- Registration Number
- NCT06085950
- Lead Sponsor
- Centre Hospitalier St Anne
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- Age between 18 and 75 years,
- Diagnosis of major depressive episode (MDE) as part of major depressive disorder as defined by DSM-5 criteria
- Severe MDE (HDRS-17> 20)
- Drug resistance to at least two well-conducted antidepressant treatment lines
- With stable antidepressant treatment for at least 4 weeks before inclusion
- Benefiting from a social security scheme
- Having given their consent to participate
- Psychiatric history other than a mood disorder
- Neurological history, including epilepsy and intracerebral calcifications
- History of substance use disorder other than tobacco
- Contraindication to brain MRI (pacemaker, neurostimulator, injury from metallic shine, ...)
- Compulsory psychiatric care
- Protected adults, people under legal safeguard
- Pregnant or breastfeeding woman
- Women of childbearing age who do not have a negative pregnancy test and are not using contraception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Transcranial Ultrasonic Stimulation with Personalized Acoustic Lens Transcranial Ultrasonic Stimulation prototype Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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
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.
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 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.
Trial Locations
- Locations (1)
GHU Sainte-Anne
🇫🇷Paris, France