Low-Intensity Focused Ultrasound for Gambling Disorder

실험적: Active LIFU Treatment

Device: Low Intensity Focused Ultrasound

• Each course comprises of three 10-minute sessions of Active LIFU per day (5 minutes to the left NAc, then 5 minutes to the right) on three treatment days scheduled within a 5-day window (i.e., nine sessions per course).
• During the randomized phase (through post-LIFU Day 30), the trial operates as a parallel-group comparison of active LIFU versus sham, with both arms receiving standard-of-care, once-weekly telehealth CBT.

장치: Active Low-Intensity Focused Ultrasound (LIFU)

Active low-intensity focused ultrasound (LIFU) neuromodulation targeting the left and right nucleus accumbens. Each treatment course comprises three 10-minute sessions per day (5 minutes to the left nucleus accumbens and 5 minutes to the right nucleus accumbens) delivered on three treatment days within a 5-day window, for a total of nine sessions. Participants also receive standard-of-care, once-weekly telehealth cognitive behavioral therapy (CBT).

가짜 비교기: Sham LIFU Treatment

Device: Low Intensity Focused Ultrasound

• Each course comprises of three 10-minute sessions of Sham LIFU per day (5 minutes to the left NAc, then 5 minutes to the right) on three treatment days scheduled within a 5-day window (i.e., nine sessions per course).
• Sham session is procedurally identical to Active LIFU session with the exception that no energy is delivered during the procedures.
• During the randomized phase (through post-LIFU Day 30), the trial operates as a parallel-group comparison of active LIFU versus sham, with both arms receiving standard-of-care once-weekly telehealth CBT.
• After the Day 30 primary endpoint and unblinding, the sham arm crosses over to open-label active LIFU and repeats the identical treatment and assessment sequence, so every participant ultimately receives active treatment.

장치: Sham Low-Intensity Focused Ultrasound (LIFU)

Sham low-intensity focused ultrasound procedures that are identical to active treatment except that no therapeutic ultrasound energy is delivered. Each treatment course comprises three 10-minute sessions per day on three treatment days within a 5-day window, for a total of nine sessions. Participants also receive standard-of-care, once-weekly telehealth cognitive behavioral therapy (CBT). After completion of the Day 30 primary endpoint assessments and unblinding, participants may cross over to receive open-label active LIFU.

Incidence of Device-Related and Procedure-Related Adverse Events

Number of participants who experience at least one device-related or investigational procedure-related adverse event (AE) or serious adverse event (SAE) during the randomized treatment phase. Adverse event severity and relationship to study procedures will be assessed by the study investigator.

Change From Baseline in Gambling Frequency Measured by the Gambling Timeline Follow-Back (G-TLFB)

The G-TLFB is a calendar-based self-report assessment that uses memory cues and a timeline method to estimate gambling activity over a specified period. Gambling frequency is assessed by retrospectively recording gambling behavior during the assessment period. Higher values indicate greater gambling frequency.

Change From Baseline in Time Spent Gambling Measured by the Gambling Timeline Follow-Back (G-TLFB)

The G-TLFB is a calendar-based self-report assessment that retrospectively records gambling behavior over a specified period. The outcome is the total time spent gambling during the assessment period. Higher values indicate greater time spent gambling.

Change From Baseline in Amount of Money Gambled Measured by the Gambling Timeline Follow-Back (G-TLFB)

The G-TLFB is a calendar-based self-report assessment that retrospectively records gambling behavior over a specified period. The outcome is the total amount of money gambled during the assessment period. Higher values indicate greater gambling expenditure.

Change From Baseline in Desire to Gamble During a Cue Reactivity Task

Participants will view gambling-related cues and rate their desire to gamble using a visual analog scale ranging from 0 to 100, where 0 indicates no desire to gamble and 100 indicates the strongest desire possible. Higher scores indicate greater desire to gamble.

Change From Baseline in Gambling Symptom Severity Measured by the Gambling Symptom Assessment Scale (GSAS)

The Gambling Symptom Assessment Scale GSAS is a 12-item self-report measure of gambling urges, thoughts, and behaviors during the previous week. Total scores range from 0 to 48, with higher scores indicating greater gambling symptom severity.

Change From Baseline in Gambling Symptom Severity Measured by the Pathological Gambling Yale-Brown Obsessive Compulsive Scale (PG-YBOCS)

The Pathological Gambling Yale-Brown Obsessive Compulsive Scale (PG-YBOCS) is a clinician-administered measure of gambling-related thoughts, urges, and behaviors. Total scores range from 0 to 40, with higher scores indicating greater gambling symptom severity.

Change From Baseline in Depression Symptom Severity Measured by the Patient Health Questionnaire-9 (PHQ-9)

The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report measure of depressive symptoms. Total scores range from 0 to 27, with higher scores indicating greater depression symptom severity.

Change From Baseline in Anxiety Symptom Severity Measured by the Generalized Anxiety Disorder-7 (GAD-7)

The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure of anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.

Change From Baseline in Quality of Life Measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF)

The World Health Organization Quality of Life-BREF (WHOQOL-BREF) is a 26-item self-report measure that assesses physical, psychological, social, and environmental domains of quality of life. Higher scores indicate better quality of life.