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Low-Intensity Focused Ultrasound for Gambling Disorder

2 de noviembre de 2026 actualizado por: Daisy Thompson-Lake, University of Virginia

A Randomized, Sham-Controlled Trial of Low Intensity Focused Ultrasound Neuromodulation as an Adjunctive Treatment for Gambling Disorder

The goal of this clinical trial is to learn whether low-intensity focused ultrasound (LIFU) is safe and may help reduce gambling-related symptoms in adults seeking treatment for gambling disorder.

The main questions it aims to answer are:

  • Is LIFU safe and well tolerated in adults with gambling disorder?
  • Does LIFU reduce gambling behavior compared with a sham (inactive) procedure?

Researchers will compare participants who receive active LIFU with participants who receive sham LIFU to see whether active treatment leads to greater reductions in gambling behavior.

Participants will:

  • Be randomly assigned to receive either active LIFU or sham LIFU.
  • Receive nine treatment sessions delivered over three treatment days within a five-day period.
  • Participate in weekly telehealth cognitive behavioral therapy (CBT).
  • Complete assessments of gambling behavior, gambling urges, mood, and quality of life.
  • Attend follow-up visits for up to 90 days after active LIFU treatment.

Low-intensity focused ultrasound is a noninvasive technique that uses focused sound waves to influence brain activity. Researchers believe this approach may affect brain circuits involved in reward, cravings, and decision-making that contribute to gambling disorder.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

54

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 60 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Adults 18 to 60 years old.
  • Currently diagnosed with gambling disorder, confirmed by a clinical interview.
  • Seeking treatment for gambling disorder, including people currently participating in or transitioning from addiction treatment programs.
  • In generally good enough physical health to safely participate in study procedures.
  • Not pregnant and not planning to become pregnant during study participation.
  • Able to speak and read English well enough to provide informed consent and complete study assessments.
  • Able to safely undergo MRI scans (for example, no metal implants or other conditions that would make MRI unsafe).
  • Willing to be randomly assigned to either study group, attend all study visits, and participate in weekly telehealth counseling sessions.

Exclusion Criteria:

  • Significant heart, lung, liver, kidney, blood vessel, or blood-clotting problems that may make participation unsafe.
  • Unwilling to avoid illegal substance use on study procedure days.
  • Currently participating in court-ordered treatment.
  • Skin or scalp conditions over the treatment area that may interfere with the study procedure.
  • A medical condition that the study doctor believes could increase the risks of the ultrasound procedure, such as a history of seizures, stroke, serious brain injury, or certain brain abnormalities.
  • Current or past schizophrenia, another psychotic disorder, or bipolar disorder.
  • Diagnosis of a Cluster A or Cluster B personality disorder.
  • Unable to safely undergo an MRI scan.
  • Pregnant or planning to become pregnant during the study.
  • Previous treatment with focused ultrasound neuromodulation or another investigational neuromodulation treatment within the past 90 days.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Dispositivo: 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).
Comparador falso: 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.
Dispositivo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of Device-Related and Procedure-Related Adverse Events
Periodo de tiempo: Randomization through Day 30

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.
Randomization through Day 30
Change From Baseline in Gambling Frequency Measured by the Gambling Timeline Follow-Back (G-TLFB)
Periodo de tiempo: Baseline to Day 30

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.
Baseline to Day 30

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Time Spent Gambling Measured by the Gambling Timeline Follow-Back (G-TLFB)
Periodo de tiempo: Baseline through Day 90 post-active LIFU treatment

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.
Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Amount of Money Gambled Measured by the Gambling Timeline Follow-Back (G-TLFB)
Periodo de tiempo: Baseline through Day 90 post-active LIFU treatment

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.
Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Desire to Gamble During a Cue Reactivity Task
Periodo de tiempo: Baseline through Day 90 post-active LIFU treatment

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.
Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Gambling Symptom Severity Measured by the Gambling Symptom Assessment Scale (GSAS)
Periodo de tiempo: Baseline through Day 90 post-active LIFU treatment

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.
Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Gambling Symptom Severity Measured by the Pathological Gambling Yale-Brown Obsessive Compulsive Scale (PG-YBOCS)
Periodo de tiempo: Baseline through Day 90 post-active LIFU treatment

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.
Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Depression Symptom Severity Measured by the Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: Baseline through Day 90 post-active LIFU treatment

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.
Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Anxiety Symptom Severity Measured by the Generalized Anxiety Disorder-7 (GAD-7)
Periodo de tiempo: Baseline through Day 90 post-active LIFU treatment

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.
Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Quality of Life Measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Periodo de tiempo: Baseline through Day 90 post-active LIFU treatment

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.
Baseline through Day 90 post-active LIFU treatment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Virginia

Colaboradores

NaviFUS Corporation

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de febrero de 2027

Finalización primaria (Estimado)

1 de diciembre de 2028

Finalización del estudio (Estimado)

1 de junio de 2029

Fechas de registro del estudio

Enviado por primera vez

2 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Publicado por primera vez (Actual)

6 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 304205

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

No

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