Low-Intensity Focused Ultrasound for Gambling Disorder
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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Virginia
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Charlottesville、Virginia、アメリカ、22903
- University of Virginia
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コンタクト：
- James Mahoney, PhD
- 電話番号：434-924-2097
- メール：jamesmahoney@virginia.edu
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コンタクト：
- Daisy Thompson-Lake, PhD
- 電話番号：434-924-2097
- メール：daisythompsonlake@virginia.edu
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Active LIFU Treatment
Device: Low Intensity Focused Ultrasound
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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). |
|
偽コンパレータ：Sham LIFU Treatment
Device: Low Intensity Focused Ultrasound
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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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Device-Related and Procedure-Related Adverse Events
時間枠：Randomization through Day 30
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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
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Change From Baseline in Gambling Frequency Measured by the Gambling Timeline Follow-Back (G-TLFB)
時間枠：Baseline to Day 30
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Time Spent Gambling Measured by the Gambling Timeline Follow-Back (G-TLFB)
時間枠：Baseline through Day 90 post-active LIFU treatment
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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
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Change From Baseline in Amount of Money Gambled Measured by the Gambling Timeline Follow-Back (G-TLFB)
時間枠：Baseline through Day 90 post-active LIFU treatment
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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
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Change From Baseline in Desire to Gamble During a Cue Reactivity Task
時間枠：Baseline through Day 90 post-active LIFU treatment
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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
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Change From Baseline in Gambling Symptom Severity Measured by the Gambling Symptom Assessment Scale (GSAS)
時間枠：Baseline through Day 90 post-active LIFU treatment
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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
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Change From Baseline in Gambling Symptom Severity Measured by the Pathological Gambling Yale-Brown Obsessive Compulsive Scale (PG-YBOCS)
時間枠：Baseline through Day 90 post-active LIFU treatment
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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
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Change From Baseline in Depression Symptom Severity Measured by the Patient Health Questionnaire-9 (PHQ-9)
時間枠：Baseline through Day 90 post-active LIFU treatment
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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
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Change From Baseline in Anxiety Symptom Severity Measured by the Generalized Anxiety Disorder-7 (GAD-7)
時間枠：Baseline through Day 90 post-active LIFU treatment
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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
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Change From Baseline in Quality of Life Measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF)
時間枠：Baseline through Day 90 post-active LIFU treatment
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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
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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