Safety and Feasibility of Next-Generation Dome Helmet (NGDH) for Focused Ultrasound Neuromodulation in Substance Use Disorder (SUD)

Safety will be evaluated by assessing the incidence, severity, and relationship of adverse events associated with FUS neuromodulation.

The Timeline Followback (TLFB) is a validated calendar-based self-report method used to assess daily alcohol consumption over a defined period. Participants will report the number of standard drinks consumed each day over the previous 30 days. The total number of days on which alcohol was consumed will be calculated.

Participants' daily alcohol consumption over the previous 30 days will be assessed using the TLFB. The average number of standard drinks per drinking day will be calculated.

Using TLFB data, the percentage of days during the assessment period on which no alcohol was consumed will be calculated.

Heavy drinking days will be defined as ≥5 drinks per day for men and ≥4 drinks per day for women. The number of such days over the assessment period will be calculated using TLFB data.

Participants will complete a brief set of self-reported Likert scales rating their current mood, anxiety, energy level, and optimism for the future. Each item is scored on a 1 to 9 scale, where:

1 = very low/poor 9 = very high/excellent These scales are used to capture rapid, subjective changes in well-being and affective state across the course of treatment.

The HAMD-17 is a clinician-administered scale with 17 items measuring the severity of depressive symptoms. Total scores range from 0 to 52, with higher scores indicating more severe depression.

Anxiety symptoms will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire. Each item is scored from 0 to 3, with a total score range of 0 to 63. Higher scores indicate greater anxiety symptom severity. Scores will be compared from baseline to post-treatment follow-up assessments.

Drug use severity will be assessed using the Drug Use Disorders Identification Test (DUDIT) in participants with drug-related substance use disorder, including stimulant, opioid, and/or ketamine use disorder. The DUDIT is an 11-item instrument used to assess drug-related problems. Items 1-9 are scored from 0 to 4, and items 10-11 are scored as 0, 2, or 4. The total score ranges from 0 to 44, with higher scores indicating greater drug use severity or greater likelihood of drug-related problems. Scores will be compared from baseline to post-treatment follow-up assessments.

The Barratt Impulsiveness Scale (BIS-11) is a widely utilized 30-item self-report instrument for assessing impulsivity. It is designed for the assessment of impulsivity in both research and clinical settings.

11-item checklist based on behaviors over the past 12 months, classified as mild (2-3 symptoms), moderate (4-5), or severe (6+). Key symptoms include failed attempts to cut down, using more than intended, cravings, neglecting obligations, and continued use despite problems.

14-item, self-report questionnaire designed to measure the frequency of psychiatric symptoms (e.g., depression, anxity, psychosis) over the past month.