Safety and Feasibility of Next-Generation Dome Helmet (NGDH) for Focused Ultrasound Neuromodulation in Substance Use Disorder (SUD)
2 juillet 2026 mis à jour par: Dr. Nir Lipsman, Sunnybrook Health Sciences Centre
Assessment of Safety and Feasibility of Focused Ultrasound (FUS) Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Substance Use Disorder (SUD)
The goal of this clinical trial is to evaluate the safety, feasibility, and preliminary clinical benefit of focused ultrasound (FUS) neuromodulation using the FUS Next Generation Dome Helmet (NGDH) in adults with treatment-resistant moderate-to-severe substance use disorder (SUD).
The main questions it aims to answer are:
Can FUS neuromodulation be safely delivered to the nucleus accumbens (NAc) and/or anterior insula (aI)? Does FUS neuromodulation result in reduced substance use severity, as measured by Timeline Followback (TLFB), by 4 weeks post-treatment?
Participants will:
Complete baseline clinical assessments, questionnaires, imaging, and safety assessments.
Undergo two MRI-guided FUS neuromodulation sessions approximately 4 weeks apart.
Attend follow-up visits for safety monitoring, symptom assessments, quality-of-life measures, and additional imaging where applicable.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
A total of 20 participants with treatment-resistant moderate-to-severe substance use disorder (SUD) will be enrolled and treated in this study.
Participants will be enrolled from the local practices of the psychiatrists/addiction physicians involved in the study and through outside referrals, including physician referrals or self-referrals.
Patient eligibility will be assessed at a screening appointment by the study coordinator and a physician associated with the study.
The anticipated enrollment period is approximately two years.
Type d'étude
Interventionnel
Inscription (Estimé)
20
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Anusha Baskaran, PhD
- Numéro de téléphone: 61650 416-480-6100
Sauvegarde des contacts de l'étude
- Nom: Nir Lipsman, MD, PhD, FRCSC
- Numéro de téléphone: (416)-480-6954
- E-mail: Nir.Lipsman@sunnybrook.ca
Lieux d'étude
-
-
Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Recrutement
- Sunnybrook Health Sciences Centre
-
Contact:
- Soraly Blanco
- Numéro de téléphone: 61519 416-480-6100
- E-mail: jaana.leppala@sunnybrook.ca
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Must be deemed to have capacity to provide informed consent (determined by the investigator)
- Age between 18 to 70 (inclusive)
- Diagnosis of SUD (cannabis, alcohol, ketamine, stimulant, opioid or nicotine/tobacco use disorder) in the moderate to severe range according to the DSM-5
- Previous ≥2 pharmacotherapy trials for the diagnosed SUD according to guideline-concordant, evidence-based care
- On a stable regimen of their psychiatric medications for 30 days before enrolment.
Exclusion Criteria:
- Pregnant or intending to be pregnant during the study
- Known active seizure disorder, significant head injury with an imaging verified lesion
- Medical illness that is deemed to be unstable or may confound the effects of the intervention
- Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)
- Unable to reliably attend the required screening, treatment, and follow up appointments.
- Severe claustrophobia, identified by the subject to be a limiting factor preventing MRI.
- Scores 18 or below on Montreal Cognitive Assessment (MoCA)
- Weighs 250 lbs or more.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Focused Ultrasound Neuromodulation - NAc First
Participants will undergo two focused ultrasound (FUS) neuromodulation sessions spaced four weeks apart.
Treatments will target the nucleus accumbens and anterior insula.
One of the two sessions may include sham exposure or active control sonication.
|
Focused ultrasound (FUS) neuromodulation delivered using the Next Generation Dome Helmet (NGDH) system under MRI guidance.
The device delivers low-intensity pulsed ultrasound to targeted brain regions, including the nucleus accumbens and anterior insula, to modulate neural activity.
Participants will undergo two treatment sessions spaced four weeks apart.
One session may include sham exposure in which the device is positioned identically but no therapeutic ultrasound energy is delivered.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence and Severity of Adverse Events
Délai: From baseline (prior to first treatment) through 4 weeks after the second treatment, including assessments on the day of each treatment, 1 day, 1 week, and 2 weeks after each treatment, and at 4 weeks after the second treatment.
|
Safety will be evaluated by assessing the incidence, severity, and relationship of adverse events associated with FUS neuromodulation.
|
From baseline (prior to first treatment) through 4 weeks after the second treatment, including assessments on the day of each treatment, 1 day, 1 week, and 2 weeks after each treatment, and at 4 weeks after the second treatment.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Number of Drinking Days Using the Timeline Followback (TLFB)
Délai: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
|
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.
|
Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
|
|
Change in Average Number of Drinks per Drinking Day Using TLFB
Délai: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
|
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.
|
Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
|
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Change in Percent Days Abstinent Using TLFB
Délai: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
|
Using TLFB data, the percentage of days during the assessment period on which no alcohol was consumed will be calculated.
|
Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
|
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Change in Number of Heavy Drinking Days Using TLFB
Délai: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
|
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.
|
Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
|
|
Subjective Ratings of Mood, Anxiety, Energy, and Optimism Using 1-9 Likert Scales
Délai: Baseline, immediately before and after each treatment, 24 hours after each treatment, and 2 and 4 weeks after the second treatment
|
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. |
Baseline, immediately before and after each treatment, 24 hours after each treatment, and 2 and 4 weeks after the second treatment
|
|
Change in Depressive Symptoms Using the Hamilton Depression Rating Scale (HAMD-17)
Délai: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second 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.
|
Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
|
|
Change in anxiety symptoms using the Beck Anxiety Inventory (BAI)
Délai: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
|
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.
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Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
|
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Change in drug use severity using the Drug Use Disorders Identification Test (DUDIT)
Délai: Baseline, 3 months after the second treatment, and 6 months after the second treatment
|
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.
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Baseline, 3 months after the second treatment, and 6 months after the second treatment
|
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Barratt Impulsiveness Scale (BIS-11)
Délai: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
|
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.
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Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
|
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DSM-5 substance use disorders symptom checklist
Délai: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment.
|
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.
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Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment.
|
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The Colorado Symptom Index (CSI)
Délai: Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
|
14-item, self-report questionnaire designed to measure the frequency of psychiatric symptoms (e.g., depression, anxity, psychosis) over the past month.
|
Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juillet 2026
Achèvement primaire (Estimé)
1 juillet 2028
Achèvement de l'étude (Estimé)
1 juillet 2028
Dates d'inscription aux études
Première soumission
8 août 2025
Première soumission répondant aux critères de contrôle qualité
2 juillet 2026
Première publication (Réel)
6 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 juillet 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 6703
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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