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Safety and Feasibility of Next-Generation Dome Helmet (NGDH) for Focused Ultrasound Neuromodulation in Substance Use Disorder (SUD)

2 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Anusha Baskaran, PhD
  • Numero di telefono: 61650 416-480-6100

Backup dei contatti dello studio

Luoghi di studio

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Reclutamento
        • Sunnybrook Health Sciences Centre
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Must be deemed to have capacity to provide informed consent (determined by the investigator)
  2. Age between 18 to 70 (inclusive)
  3. Diagnosis of SUD (cannabis, alcohol, ketamine, stimulant, opioid or nicotine/tobacco use disorder) in the moderate to severe range according to the DSM-5
  4. Previous ≥2 pharmacotherapy trials for the diagnosed SUD according to guideline-concordant, evidence-based care
  5. On a stable regimen of their psychiatric medications for 30 days before enrolment.

Exclusion Criteria:

  1. Pregnant or intending to be pregnant during the study
  2. Known active seizure disorder, significant head injury with an imaging verified lesion
  3. Medical illness that is deemed to be unstable or may confound the effects of the intervention
  4. Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)
  5. Unable to reliably attend the required screening, treatment, and follow up appointments.
  6. Severe claustrophobia, identified by the subject to be a limiting factor preventing MRI.
  7. Scores 18 or below on Montreal Cognitive Assessment (MoCA)
  8. Weighs 250 lbs or more.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: Next Generation Dome Helmet (NGDH)
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence and Severity of Adverse Events
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Number of Drinking Days Using the Timeline Followback (TLFB)
Lasso di tempo: 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
Lasso di tempo: 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
Change in Percent Days Abstinent Using TLFB
Lasso di tempo: 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
Change in Number of Heavy Drinking Days Using TLFB
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.
Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
Change in drug use severity using the Drug Use Disorders Identification Test (DUDIT)
Lasso di tempo: 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.
Baseline, 3 months after the second treatment, and 6 months after the second treatment
Barratt Impulsiveness Scale (BIS-11)
Lasso di tempo: 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.
Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment
DSM-5 substance use disorders symptom checklist
Lasso di tempo: 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.
Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment.
The Colorado Symptom Index (CSI)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sunnybrook Health Sciences Centre

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 luglio 2028

Completamento dello studio (Stimato)

1 luglio 2028

Date di iscrizione allo studio

Primo inviato

8 agosto 2025

Primo inviato che soddisfa i criteri di controllo qualità

2 luglio 2026

Primo Inserito (Effettivo)

6 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 6703

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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