Clinical trial NCT06894966: Towards a Targeted Ultrasound Neuromodulation Intervention for Alcohol Abuse Disorders
Official title: Targeted Therapeutic Transcranial Focused Ultrasound Intervention for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: focused ultrasound
TUS
neuromodulation
AUD
Transcranial Ultrasound Stimulation
Lead sponsor: University of Plymouth
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Within subject, randomized, double-blind, sham-controlled trial
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria will be:

* Male or female, aged 21-55 years, and fluent English speaking.
* Participants score ≥ 20 on the AUDIT.
* Participant is willing and able to give informed consent for participation in the trial.
* Participant is willing to comply with all trial requirements and committed to participating in all six testing sessions.

Exclusion Criteria will be:

The participant may not enter the trial if ANY of the following apply.

History:

* serious head trauma or brain surgery
* (first-degree relatives with) epilepsy, convulsion, or seizure
* diagnosis of a neurological or psychiatric disorder (other than AUD)
* adverse reactions to non-invasive brain stimulation
* participation in another short-term non-invasive brain stimulation study in the past 3 days
* participation in another long-term non-invasive brain stimulation study in the past 28 days
* recent head trauma that was diagnosed as a concussion or associated with loss of consciousness

Current:

* pregnancy or planning a pregnancy during the course of the trial
* use of psychoactive drugs or any drugs listed in the Neurostimulation Safety Report
* heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement
* metal in the head or body
* claustrophobia
* extreme mood fluctuations
* predisposition to fainting spells (syncope)
* medication that will interfere with the study or constitutes an increased risk of adverse effects (e.g., affects brain excitability)
* hearing problems or ringing in the ears
* skin diseases or sensitivity at intended TUS stimulation site
* Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Last 24 hours:

* more than four alcoholic units
* recreational psychoactive drugs
* antibiotics

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Immediately after TUS session; one day and one week after TUS. Same for sham, to compare the TUS active and sham.
Secondary outcomes:
measure: Change in AUD symptoms
timeFrame: immediately prior to TUS sessions, within 1 hour post TUS and every day that follow TUS for 7 days
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Health
state: Devon
Study officials:
References: