Investigating Low Intensity Focused Ultrasound Pulsation (LIFUP) in Anhedonic Depression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- University of California, Los Angeles
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Change in Patient health questionnaire-14 self report measure (PHQ-14) from baseline
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study will observe changes in brain imaging, behavior, and symptom measures following intervention with low intensity focused ultrasound pulsation (LIFUP) targeting reward circuitry in individuals who are depressed and anhedonic.
Detailed Description
Participants will wear a provided Apple watch and download a study app to their personal phones in order for activity and phone use metrics to be collected. Participants will respond to weekly email surveys, daily ecological momentary assessment (EMA) surveys, complete computer-based neurocognitive assessments, undergo a baseline MRI scan with spectroscopy, receive 3 sessions of LIFUP sonication, undergo a follow up MRI with spectroscopy, then continue to be followed with surveys, neurocognitive assessment, and watch/phone data collection for 3 weeks after follow up MRI scan. Participants will be randomized 1:1 active:sham to receive LIFUP targeting the caudate head of the brain. Conditions will be double blinded so that neither participants nor investigators or research staff know if active or sham sonication is being administered.
Investigators
Michelle Craske
Distinguished Professor
University of California, Los Angeles
Eligibility Criteria
Inclusion Criteria
- •• Between the ages of 18 and 65
- •Fluent in English
- •Own functioning iOS smart phone (iPhone 8 or later, iOS 15 or newer) with access to reliable data plan and Wi-Fi
- •Right-handed
- •Normal or corrected to normal vision
- •Willingness to participate in the study, including wearing the provided Apple Watch, respond to remote survey prompts, complete an MRI scan, and provide a recorded interview.
- •Able to read and understand a written informed consent form
- •Reside in the Los Angeles area for the duration of the study
- •If enrolled in IRB#22-000059, have completed the majority of assessments.
- •Eligible for MRI scanning and neuromodulation
Exclusion Criteria
- •Current tobacco smoker of \>11 cigarettes/day or the nicotine equivalent
- •Current report of alcohol or substance abuse or dependence
- •Recent changes in antidepressant dosing or medication (dose and medication need to be stabilized within the last 2 weeks)
- •Any diagnosis of major neurological condition impairing mobility, cognition, or language ability including multiple sclerosis, Parkinson's disease or other movement disorder, motor neuron disease, stroke, dementia
- •Any other diagnosis involving chronic mobility impairment including spinal cord injuries, or severe osteoarthritis of knee or hip
- •Reported diagnosis of schizophrenia or psychotic symptoms
- •Participants currently taking benzodiazepines must agree to refrain from taking this medication for 12 hours before their scan, as well as refrain from any allergy or cold medication (diphenhydramine) that causes sleepiness (e.g. Benadryl).
- •History of brain tumor or brain surgery
- •History of stroke or seizure
- •Contraindications for MRI scanning, including pregnancy, metal implants, braces, significant grip impairment and claustrophobia
Outcomes
Primary Outcomes
Change in Patient health questionnaire-14 self report measure (PHQ-14) from baseline
Time Frame: Week 0, Pre-scan, Baseline, week 1, week 2 week 3, week 4, week 5
Validated, self-report, 14 item assessment of depressive symptoms in the past 2 weeks. Score range 0- 24. Higher scores indicate higher severity of depressive symptoms.
Change in Positive valence systems scale-21 self report measure (PVSS-21) from baseline
Time Frame: Week 0, Pre-scan, Baseline, week 1, week 2 week 3, week 4, week 5
Validated, self-report 21 item assessment of reward sensitivity. 13 subscales measure different domains of reward sensitivity (range 3-27), with total score (range 1-9) representing overall reward sensitivity. Lower scores indicate more anhedonic responses.
Changes in MRI images from Pre-scan to week 5
Time Frame: Pre-scan, week 5
changes in fMRI resting state connectivity, spectroscopy (concentration of glutamate and GABA in the ACC region), and task-based neural activation (using card guessing task) Card Guessing Task: During the scan, participants are asked to guess the value of cards presented on a screen, and are provided immediate feedback as to whether their guesses were correct or not. Participants are informed prior to performing the task, that money is awarded for each correct guess. This task measures reward sensitivity. Apple Gathering Task: Effort is expended by participants squeezing a hand-grip measurement tool, which translates a signal to the screen showing the amount of effort they are expending to receive a pre-determined amount of "reward". Participants can accept or reject trials of effort based on the amount of reward they would be due to receive. This task measures reward sensitivity and motivation.
Change in Ecological momentary assessment (EMA) from W0/Baseline
Time Frame: Week 0, Pre-scan, Baseline, week 1, week 2 week 3, week 4, week 5
Ecological momentary assessment (EMA) is a custom 16 item self-report assessment of in-the moment mood and activity. This is a data collection instrument without a standardized scoring method.
Secondary Outcomes
- Changes in digital behavioral phenotype sleep measurement(Week 0, Pre-scan, Baseline, week 1, week 2 week 3, week 4, week 5)
- Changes in digital behavioral phenotype physical activity measurement(Week 0, Pre-scan, Baseline, week 1, week 2 week 3, week 4, week 5)
- Changes in heart rate(Week 0, Pre-scan, Baseline, week 1, week 2 week 3, week 4, week 5)
- Changes in heart rate variability(Week 0, Pre-scan, Baseline, week 1, week 2 week 3, week 4, week 5)
- Changes in respiratory rate(Week 0, Pre-scan, Baseline, week 1, week 2 week 3, week 4, week 5)
- changes in World Health Organization (WHO) -5 Wellbeing index score from W0/Baseline to end of study(Week 0/Baseline, week 5)
- changes in Pittsburgh Sleep Quality Index (PSQI) score from W0/Baseline to end of study(Week 0/Baseline, week 5)