Transcranial Ultrasonic Stimulation in Treatment-resistant Depression : an Open-label Pilot Trial - Clinical Trial for Treatment Resistant Depression | NCT06085950

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Transcranial Ultrasonic Stimulation prototype

About this trial

This is an interventional treatment trial for Treatment Resistant Depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

GHU Sainte-AnneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial Ultrasonic Stimulation with Personalized Acoustic Lens

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

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.

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.

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.

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.

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

Full Information

NCT ID

NCT06085950

First Posted

September 12, 2023

Last Updated

October 10, 2023

Sponsor

Centre Hospitalier St Anne

1. Study Identification

Unique Protocol Identification Number

NCT06085950

Brief Title

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

Acronym

StimulUS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 9, 2023 (Actual)

Primary Completion Date

May 13, 2024 (Anticipated)

Study Completion Date

June 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier St Anne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Treatment Resistant Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transcranial Ultrasonic Stimulation with Personalized Acoustic Lens

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Transcranial Ultrasonic Stimulation prototype

Intervention Description

Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation

Primary Outcome Measure Information:

Title

Percent change in the Montgomery-Åsberg Depression Scale (MADRS) score from baseline to primary endpoint

Description

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.

Time Frame

Pre-treatment and Day 5 from start of intervention

Secondary Outcome Measure Information:

Title

Incidence of serious adverse reactions according to the Common Terminology Criteria for Adverse Events (CTCAE) scale

Description

CTCAE are a set of criteria for the standardized classification of adverse effects

Time Frame

Day 1 to Day 35 from start of intervention

Title

Percent change in the Montgomery-Åsberg Depression Scale (MADRS)

Description

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.

Time Frame