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Recruiting NCT06085950

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

No phase Interventional Treatment Resistant Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial Ultrasonic Stimulation prototype.
Who it may be relevant to
Registry conditions: Treatment Resistant Depression. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Transcranial Ultrasonic Stimulation prototype
    Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation

Primary outcome measures

  • Percent change in the Montgomery-Åsberg Depression Scale (MADRS) score from baseline to primary endpoint [Time frame: Pre-treatment and Day 5 from start of intervention]
Secondary outcome measures (7)
  • Incidence of serious adverse reactions according to the Common Terminology Criteria for Adverse Events (CTCAE) scale [Time frame: Day 1 to Day 35 from start of intervention]
  • Percent change in the Montgomery-Åsberg Depression Scale (MADRS) [Time frame: 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]
  • Percent change in the Hamilton Rating Scale for Depression (HDRS-17) [Time frame: 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]
  • Percent change in the Hamilton Rating Scale for Depression (HDRS-6) [Time frame: 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]
  • Percent change in the Inventory of Depressive Symptomatology (IDC-C) [Time frame: 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]
  • Percent change in the Quick Inventory of Depressive Symptomatology (QIDS-SR) [Time frame: 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]
  • Assess the changes in functional connectivity of sgACC after TUS [Time frame: Pre-treatment and Day 7 from start of intervention]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • GHU Sainte-Anne — Paris

Publications

  • Attali D, Tiennot T, Manuel TJ, Daniel M, Houdouin A, Annic P, Dizeux A, Haroche A, Dadi G, Henensal A, Moyal M, Le Berre A, Paolillo C, Charron S, Debacker C, Lui M, Lekcir S, Mancusi R, Gallarda T, Sharshar T, Sylla K, Oppenheim C, Cachia A, Tanter M, Aubry JF, Plaze M. Deep transcranial ultrasound stimulation using personalized acoustic metamaterials improves treatment-resistant depression in h PMID 40311843

Identifiers

NCT: NCT06085950 · D21-P020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗