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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Treatment Resistant Depression
• Intervention / Treatment: Device: Transcranial Ultrasonic Stimulation prototype

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion PLAZE; Phone Number: +33 1 45 65 87 20; Email: m.plaze@ghu-paris.fr
• Study Contact Backup: Name: David ATTALI; Email: d.attali@ghu-paris.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • GHU Sainte-Anne
    • Contact: Marion Plaze, MD, PHD; Phone Number: 0145658720; Email: m.plaze@ghu-paris.fr
    • Contact: David ATTALI, MD, PHD; Email: d.attali@ghu-paris.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcranial Ultrasonic Stimulation with Personalized Acoustic Lens; Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull	Device: Transcranial Ultrasonic Stimulation prototype; Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in the Montgomery-Åsberg Depression Scale (MADRS) score from baseline to primary endpoint	MADRS is a ten item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.	Pre-treatment and Day 5 from start of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of serious adverse reactions according to the Common Terminology Criteria for Adverse Events (CTCAE) scale	CTCAE are a set of criteria for the standardized classification of adverse effects	Day 1 to Day 35 from start of intervention
Percent change in the Montgomery-Åsberg Depression Scale (MADRS)	MADRS is a ten item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.	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)	HDRS-17 is a 17 item questionnaire used to score the severity of depression. Scale range - 0 to 52 with higher score indicative of greater depressive symptomology.	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)	HDRS-6 is a 6 item questionnaire used to score the severity of depression. Scale range - 0 to 22 with higher score indicative of greater depressive symptomology.	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)	IDS-C is a 30 item questionnaire used to score the severity of depression. Scale range - 0 to 90 with higher score indicative of greater depressive symptomology.	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)	QIDS-SR is a 16 item self-administered questionnaire used to score the severity of depression. Scale range - 0 to 27 with higher score indicative of greater depressive symptomology.	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	Comparison of functional connectivity of subgenual cingulate cortex through resting state imaging analysis before / after intervention	Pre-treatment and Day 7 from start of intervention

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): May 13, 2024
• Study Completion (Estimated): June 12, 2024

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: D21-P020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No