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Low-Intensity Focused Ultrasound for Gambling Disorder

2. november 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

54

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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).
Sham-komparator: 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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Device-Related and Procedure-Related Adverse Events
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Virginia

Samarbeidspartnere

NaviFUS Corporation

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. februar 2027

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

1. juni 2029

Datoer for studieregistrering

Først innsendt

2. november 2026

Først innsendt som oppfylte QC-kriteriene

2. november 2026

Først lagt ut (Faktiske)

6. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 304205

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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