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| ID | Type | Description | Link |
|---|---|---|---|
| MR/Y034368/1 | Other Grant/Funding Number | UKRI MRC |
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This study explores the potential of transcranial ultrasound stimulation (TUS) as an innovative therapeutic approach for individuals with Alcohol Use Disorder. By targeting specific brain regions associated with compulsive behaviors and reward dysfunction, the researchers aim to assess the safety and efficacy of TUS in reducing symptoms and enhancing cognitive flexibility.
Alcohol Use Disorder (AUD) is a prevalent and highly debilitating condition characterized by compulsive alcohol consumption, loss of control over drinking behavior, and significant impairment in social functioning and quality of life. Estimates suggest that the economic burden of AUD is substantial, with alcohol-related harm costing the UK over £21 billion per year (Public Health England, 2016). There is a pressing need for novel interventions that surpass current treatment approaches in both effectiveness and comprehensiveness, addressing the neural and behavioral mechanisms underlying AUD. Low-intensity transcranial focused ultrasound stimulation (TUS) is an emerging non-invasive brain stimulation technique with the potential to modulate neural activity with high spatial precision.
The neural basis of AUD involves dysfunction across several brain regions, including the prefrontal cortex (impaired executive control: Koob & Volkow, 2016), the striatum (habit formation and reinforcement: Everitt & Robbins, 2016), the amygdala (heightened stress reactivity: Koob, 2021), and the thalamus (altered sensory and reward processing: Müller-Oehring et al., 2015). TUS can precisely modulate neuronal activity in both cortical and subcortical regions, making it a promising tool for targeting the disrupted neurocircuitry of AUD. This study aims to explore the safety and efficacy of TUS in modulating key brain regions involved in compulsive alcohol use and cognitive control, with the goal of reducing AUD-related symptoms and improving treatment outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low intensity transcranial focused ultrasound stimulation (TUS) | Other | double-blind, sham-controlled, crossover study in N=30 individuals with OCD |
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| low intensity transcranial focused ultrasound stimulation (TUS) Sham | Other | double-blind, sham-controlled, crossover study in N=30 individuals with OCD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low intensity transcranial focused ultrasound stimulation (TUS) | Device | Low-intensity transcranial focused ultrasound (TUS) provides an energy source with millimeter resolution that can be focused anywhere in the brain safely and effectively for non-invasive and transient neuromodulation. TUS is an important advance and of great significance for brain-mapping efforts, diagnostics, and therapies in neuroscience and particularly promising for addiction therapy as it provides unprecedented non-surgical access to the brain regardless of depth. Low intensities of focused ultrasound (TUS) are used so that tissue damage does not occur, but neural activity can be modulated by mechanical effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | number of adverse events | Immediately after TUS session; one day and one week after TUS. Same for sham, to compare the TUS active and sham. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in AUD symptoms | numerical AUD symptoms rating scale and Alcohol Consumptions | immediately prior to TUS sessions, within 1 hour post TUS and every day that follow TUS for 7 days |
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Inclusion Criteria will be:
Exclusion Criteria will be:
The participant may not enter the trial if ANY of the following apply.
History:
Current:
Last 24 hours:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elsa Fouragnan, PhD | Contact | 7703335897 | +44 | elsa.fouragnan@plymouth.ac.uk |
| Suraya Dunsford, PhD | Contact | 01752585858 | +44 | suraya.dunsford@plymouth.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health | Plymouth | Devon | PL4 8AA | United Kingdom |
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| Label | URL |
|---|---|
| safety report for TUS use from expert consortium | View source |
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Anonymous behavioral data upon publication
data will be available after analysis of primary and secondary outcomes are completed
anyone with access to the link to the data (OSF)
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Within subject, randomized, double-blind, sham-controlled trial
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