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

Last updated: October 10, 2023
Sponsor: Centre Hospitalier St Anne
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Treatment

Transcranial Ultrasonic Stimulation prototype

Clinical Study ID

NCT06085950
D21-P020
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 18 and 75 years,
  • Diagnosis of major depressive episode (MDE) as part of major depressive disorder asdefined 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

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 usingcontraception

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Transcranial Ultrasonic Stimulation prototype
Phase:
Study Start date:
May 09, 2023
Estimated Completion Date:
June 12, 2024

Connect with a study center

  • GHU Sainte-Anne

    Paris, 75014
    France

    Active - Recruiting

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