Suspended

StimulUSTranscranial Ultrasonic Stimulation in Treatment-resistant Depression: an Open-label Pilot Trial

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What is being tested

Transcranial Ultrasonic Stimulation prototype

Device
Who is being recruted

Mental Disorders+1

+ Depressive Disorder

+ Mood Disorders

From 18 to 75 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2023
See protocol details

Summary

Principal SponsorCentre Hospitalier St Anne
Study ContactMarion PLAZEMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 9, 2023

Actual date on which the first participant was enrolled.

This study focuses on exploring a new approach to help people with treatment-resistant depression, a condition where traditional treatments like medication and therapy haven't been effective. Researchers are looking into a technique called transcranial ultrasonic stimulation (TUS), which uses sound waves to potentially improve symptoms of depression. The goal is to fine-tune how this method should be used and see if it might be helpful for patients who haven't found relief through other treatments. Participants in the study will undergo TUS, a non-invasive procedure applied to the head. The study aims to determine the best way to deliver this treatment and observe its effects on depression symptoms. As this is a pilot trial, it is mainly about adjusting the treatment process and getting an initial sense of how well it works rather than definitive results. The safety and effectiveness of TUS will be closely monitored throughout the study.

Official TitleTranscranial Ultrasonic Stimulation in Treatment-resistant Depression: an Open-label Pilot Trial
NCT06085950
Principal SponsorCentre Hospitalier St Anne
Study ContactMarion PLAZEMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersDepressive DisorderMood DisordersDepressive Disorder, Treatment-Resistant

Criteria

7 inclusion criteria required to participate
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

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8 exclusion criteria prevent from participating
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, …)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

GHU Sainte-Anne

Paris, FranceOpen GHU Sainte-Anne in Google Maps
SuspendedOne Study Center