Interventional Recruiting
NCT06085950 on ClinicalTrials.gov
Transcranial Ultrasonic Stimulation in Treatment-resistant Depression : an Open-label Pilot Trial
Official title: Transcranial Ultrasonic Stimulation in Treatment-resistant Depression: an Open-label Pilot Trial
- Sponsor: Centre hospitalier
- Enrollment: 32 (Estimated)
- Study start: 2023-05-09 (Actual)
- Primary completion: 2028-05-01 (Estimated)
- Study completion: 2028-06-01 (Estimated)
- Allocation: Non-Randomized
- InterventionModel: Sequential
- Masking: None
- PrimaryPurpose: Treatment
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.
Conditions
- Treatment Resistant Depression
Intervention / Treatment
- Device: Transcranial Ultrasonic Stimulation prototype
Primary Outcome Measures
-
Percent change in the Montgomery-Ã…sberg 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.
Countries
France
Locations and Investigators
-
GHU Sainte-Anne, Paris, France (Recruiting)
- Marion Plaze, MD, PHD
- David ATTALI, MD, PHD