Personalized Ultrasonic Brain Stimulation for Depression

• Sponsor: University of Utah (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05301036
• Collaborator: (none)
• Enrollment: 20
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Episode	Device: Diadem prototype	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Personalized Ultrasonic Brain Stimulation for Depression: A Pilot Study of Target Engagement and Mood Effects
• Anticipated Study Start Date: Jun 15, 2022
• Anticipated Primary Completion Date: Jun 14, 2024
• Anticipated Study Completion Date: Jun 14, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active stimulation Personalized low-intensity transcranial focused ultrasound stimulation of deep brain target (subgenual cingulate or alternative targets)	Device: Diadem prototype; Diadem prototype device delivers personalized low-intensity transcranial focused ultrasound stimulation
Sham Comparator: Sham stimulation Personalized low-intensity transcranial focused ultrasound stimulation of lateral ventricle	Device: Diadem prototype; Diadem prototype device delivers personalized low-intensity transcranial focused ultrasound stimulation

Outcome Measures

Primary Outcome Measures

1. Target engagement: MRI quantification of brain activation [1 day at MRI study visit]

   Blood oxygenation level dependent (BOLD) or arterial spin labeling (ASL) response to active versus sham stimulation

2. Target engagement: MRI quantification of brain connectivity [1 day at MRI study visit]

   Resting functional connectivity of target in response to active versus sham stimulation

3. Mood effects: momentary mood change [1 day at stimulation study visit]

   4-item Affect Change Scale: valence, arousal, depression, anxiety

4. Mood effects: subjective mood state [1 day at stimulation study visit]

   Positive and Negative Affect Schedule Extended (PANAS-X)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Utah

Investigators

• Principal Investigator: Brian J Mickey, MD, PhD, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brian Mickey, Associate Professor of Psychiatry, University of Utah
• ClinicalTrials.gov Identifier: NCT05301036
• Other Study ID Numbers: IRB_00148802
• First Posted: Mar 29, 2022
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression

Study Results

No Results Posted as of May 18, 2022