Personalized Ultrasonic Brain Stimulation for Depression

NCT ID: NCT05301036

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2024-12-14

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.

Conditions

Major Depressive Episode

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active stimulation

Personalized low-intensity transcranial focused ultrasound stimulation of deep brain target (subgenual cingulate or alternative targets)

Group Type: EXPERIMENTAL

Diadem prototype

Intervention Type: DEVICE

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

Sham stimulation

Personalized low-intensity transcranial focused ultrasound stimulation of lateral ventricle

Group Type: SHAM_COMPARATOR

Diadem prototype

Intervention Type: DEVICE

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

Interventions

Diadem prototype

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Brian Mickey

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian J Mickey, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

Riis TS, Feldman DA, Vonesh LC, Brown JR, Solzbacher D, Kubanek J, Mickey BJ. Durable effects of deep brain ultrasonic neuromodulation on major depression: a case report. J Med Case Rep. 2023 Oct 28;17(1):449. doi: 10.1186/s13256-023-04194-4.

Reference Type: DERIVED

PMID: 37891643 (View on PubMed)

Other Identifiers

IRB_00148802

Identifier Type: -

Identifier Source: org_study_id