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

Centre Hospitalier St Anne

Status: Enrolling

Conditions: Treatment Resistant Depression

Treatments: Device: Transcranial Ultrasonic Stimulation prototype

Study type: Interventional

Funder types: Other

Identifiers

NCT06085950

D21-P020

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Transcranial Ultrasonic Stimulation with Personalized Acoustic Lens

Experimental group

Description:

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

Treatment:

Device: Transcranial Ultrasonic Stimulation prototype