Towards a Targeted Ultrasound Neuromodulation Intervention for Alcohol Abuse Disorders (TUS-AUD)

March 19, 2025 updated by: Elsa Fouragnan, University of Plymouth

Targeted Therapeutic Transcranial Focused Ultrasound Intervention for Alcohol Use Disorder

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: low intensity transcranial focused ultrasound stimulation (TUS)
double-blind, sham-controlled, crossover study in N=30 individuals with OCD
Device: low intensity transcranial focused ultrasound stimulation (TUS)
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.
Other: low intensity transcranial focused ultrasound stimulation (TUS) Sham
double-blind, sham-controlled, crossover study in N=30 individuals with OCD
Device: low intensity transcranial focused ultrasound stimulation (TUS)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: Immediately after TUS session; one day and one week after TUS. Same for sham, to compare the TUS active and sham.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in AUD symptoms
Time Frame: immediately prior to TUS sessions, within 1 hour post TUS and every day that follow TUS for 7 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Plymouth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2025

Primary Completion (Estimated)

September 19, 2026

Study Completion (Estimated)

September 20, 2026

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-4914-6227
  • MR/Y034368/1 (Other Grant/Funding Number: UKRI MRC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymous behavioral data upon publication

IPD Sharing Time Frame

data will be available after analysis of primary and secondary outcomes are completed

IPD Sharing Access Criteria

anyone with access to the link to the data (OSF)

IPD Sharing Supporting Information Type

  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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