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Taking people in FranceNo phase

Tests an ultrasound brain device for depression that has not improved with treatment

Tests a prototype ultrasound device on the brain in adults with treatment-resistant depression.

Key facts

Who runs it
Centre Hospitalier St Anne
Where
Paris, FranceSee the site
Trial code
Registry title
Transcranial Ultrasonic Stimulation in Treatment-resistant Depression : an Open-label Pilot Trial
Status
Recruiting
People taking part
32 people, planned
Started
9 May 2023
Expected to end
Jun 2028
Type of study
Interventional, 4 groups
Treatments tested
  • Transcranial Ultrasonic Stimulation prototype
Record updated
22 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 75 with severe depression that has not responded to at least two antidepressant treatments.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Severe major depressive episode as part of major depressive disorder (HDRS-17 score above 20).
Earlier treatment
Drug resistance to at least two well-conducted antidepressant treatments. Antidepressant treatment must be stable for at least 4 weeks before joining.

Main reasons for not taking part

  • 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 (such as a pacemaker or neurostimulator)
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Psychiatric history other than a mood disorder
  • Neurological history, including epilepsy and intracerebral calcifications
  • History of substance use disorder other than tobacco
  • Compulsory psychiatric care
  • Women of childbearing age who do not have a negative pregnancy test and are not using contraception
  • Contraindication to brain MRI (pacemaker, neurostimulator, injury from metallic shine, …)
  • Protected adults, people under legal safeguard
  • Pregnant or breastfeeding woman

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in France

  • GHU Sainte-AnneParis, FranceContact: Marion Plaze, MD, PHDTaking people

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • TUS - 5 min sessions, 5% duty cycle, 5 sessions/day (n=5)Treatment being tested

    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).

    Treatment: Transcranial Ultrasonic Stimulation prototype

  • TUS - 40 min sessions, 5% duty cycle, 2 sessions/day (n=7)Treatment being tested

    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).

    Treatment: Transcranial Ultrasonic Stimulation prototype

  • TUS - 40 min sessions, 1% duty cycle, increased acoustic power, 2 sessions/day (n=10)Treatment being tested

    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).

    Treatment: Transcranial Ultrasonic Stimulation prototype

  • TUS - 40 min sessions, 5% duty cycle, increased acoustic power, 2 sessions/day (n=10)Treatment being tested

    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).

    Treatment: Transcranial Ultrasonic Stimulation prototype

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Transcranial Ultrasonic Stimulation in Treatment-resistant Depression: an Open-label Pilot Trial
Plain-language title
Tests an ultrasound brain device for depression that has not improved with treatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06085950, who can take part
Record updated
22 June 2026