Alcohol Use DisorderTUS-AUDNCT06894966
Towards a Targeted Ultrasound Neuromodulation Intervention for Alcohol Abuse Disorders
A study testing low intensity transcranial focused ultrasound stimulation (TUS) in people with Alcohol Use Disorder, run by University of Plymouth at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- low intensity transcranial focused ultrasound stimulation (TUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Apr 2025to 20 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Health
Plymouth, Devon, PL4 8AA
Elsa Fouragnan, 07703335897, elsa.fouragnan@plymouth.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- low intensity transcranial focused ultrasound stimulation (TUS)
- Keywords
- focused ultrasound, TUS, neuromodulation, AUD, Transcranial Ultrasound Stimulation
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| low intensity transcranial focused ultrasound stimulation (TUS) | Other | double-blind, sham-controlled, crossover study in N=30 individuals with OCD Receives: Device: low intensity transcranial focused ultrasound stimulation (TUS) |
| low intensity transcranial focused ultrasound stimulation (TUS) Sham | Other | double-blind, sham-controlled, crossover study in N=30 individuals with OCD Receives: Device: low intensity transcranial focused ultrasound stimulation (TUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
number of adverse events
Measured: Immediately after TUS session; one day and one week after TUS. Same for sham, to compare the TUS active and sham.
Secondary outcomes (1)
Change in AUD symptoms
numerical AUD symptoms rating scale and Alcohol Consumptions
Measured: immediately prior to TUS sessions, within 1 hour post TUS and every day that follow TUS for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start20 Apr 2025 (estimated)
- Primary completion19 Sep 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within subject, randomized, double-blind, sham-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsa Fouragnan, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894966
- Sponsor's protocol ID
- 2024-4914-6227
- Other IDs
- MR/Y034368/1
- Acronym
- TUS-AUD
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous behavioral data upon publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Therapeutic Transcranial Focused Ultrasound Intervention for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT06894966
- Acronym / sponsor ID
- TUS-AUD / 2024-4914-6227
- Conditions
- Alcohol Use Disorder
- Keywords
- focused ultrasound, TUS, neuromodulation, AUD, Transcranial Ultrasound Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 19 Sep 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Within subject, randomized, double-blind, sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| low intensity transcranial focused ultrasound stimulation (TUS) | Other | Device: low intensity transcranial focused ultrasound stimulation (TUS)double-blind, sham-controlled, crossover study in N=30 individuals with OCD |
| low intensity transcranial focused ultrasound stimulation (TUS) Sham | Other | Device: low intensity transcranial focused ultrasound stimulation (TUS)double-blind, sham-controlled, crossover study in N=30 individuals with OCD |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (25 listed)
- The participant may not enter the trial if ANY of the following apply.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | low intensity transcranial focused ultrasound stimulation (TUS), low intensity transcranial focused ultrasound stimulation (TUS) Sham |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- safety report for TUS use from expert consortiumLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymous behavioral data upon publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low intensity transcranial focused ultrasound stimulation (TUS) in people with Alcohol Use Disorder, run by University of Plymouth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elsa Fouragnan, PhD (7703335897 ext. +44, elsa.fouragnan@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.