Personalized Ultrasonic Brain Stimulation for Depression

Major Depressive Episode Clinical Trial

Official title:

Personalized Ultrasonic Brain Stimulation for Depression: A Pilot Study of Target Engagement and Mood Effects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05301036
• Other study ID #: IRB_00148802
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 15, 2022
• Est. completion date: July 14, 2024

Study information

• Verified date: April 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate a new form of non-invasive brain stimulation for individuals with depression. Personalized low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychological and physiological monitoring. A well-tolerated stimulation protocol will then be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial to evaluate brain target engagement using magnetic resonance imaging.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 14, 2024
• Est. primary completion date: July 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 18-65, any gender

2. Primary diagnosis of major depressive disorder or bipolar disorder

3. Current moderate-to-severe depressive episode, without psychotic features, lasting at least 2 months

4. Self-rated 16-item Quick Inventory of Depressive Symptomatology (QIDS) total score > 10

5. Stated willingness to comply with all study procedures and avoid changes to psychiatric treatments (medications, psychotherapy) for the duration of the study

6. For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study

7. Capacity to provide informed consent; provision of a signed and dated consent form

Exclusion Criteria:

1. History of serious brain injury or other neurologic disorder

2. Poorly managed general medical condition

3. Pregnant or breast feeding

4. Implanted device in the head or neck

5. MRI intolerance or contraindication

6. Brain stimulation (e.g., ECT, TMS, VNS) in the past month

7. Suicidal ideation (Columbia Suicide Severity Rating Scale screen item #2, past month)

8. Lifetime history of a serious suicide attempt

9. Moderate-to-severe substance use disorder (past 3 months)

10. Obsessive compulsive disorder (past month)

11. Posttraumatic stress disorder (past month)

12. Schizophrenia-spectrum disorder (lifetime)

13. Neurocognitive disorder (past year)

14. Personality disorder as a current focus of treatment

15. Clinically inappropriate for participation in the study as determined by the study team

Related Conditions & MeSH terms

• Depression
• Major Depressive Episode

Intervention

Device:
• Diadem prototype
Diadem prototype device delivers personalized low-intensity transcranial focused ultrasound stimulation

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target engagement: MRI quantification of brain activation	Blood oxygenation level dependent (BOLD) or arterial spin labeling (ASL) response to active versus sham stimulation	1 day at MRI study visit
Primary	Target engagement: MRI quantification of brain connectivity	Resting functional connectivity of target in response to active versus sham stimulation	1 day at MRI study visit
Primary	Mood effects: momentary mood change	4-item Affect Change Scale: valence, arousal, depression, anxiety	1 day at stimulation study visit
Primary	Mood effects: subjective mood state	Positive and Negative Affect Schedule Extended (PANAS-X)	1 day at stimulation study visit