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

Treatment Resistant Depression Clinical Trial

— StimulUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06085950
• Other study ID #: D21-P020
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2023
• Est. completion date: June 12, 2024

Study information

• Verified date: September 2023
• Source: Centre Hospitalier St Anne
• Contact: Marion PLAZE
• Phone: +33 1 45 65 87 20
• Email: m.plaze[@]ghu-paris.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 12, 2024
• Est. primary completion date: May 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

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

Locations

Country	Name	City	State
France	GHU Sainte-Anne	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier St Anne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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