Towards a Targeted Ultrasound Neuromodulation Intervention for Alcohol Abuse Disorders

NCT06894966 | Not Yet Recruiting

• 2 other identifiers: 2024-4914-6227MR/Y034368/1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

focused ultrasound; TUS; neuromodulation; AUD; Transcranial Ultrasound Stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Change in AUD symptoms

  immediately prior to TUS sessions, within 1 hour post TUS and every day that follow TUS for 7 days

Study Arms (2)

low intensity transcranial focused ultrasound stimulation (TUS)

OTHER

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 stimulation (TUS) Sham

OTHER

double-blind, sham-controlled, crossover study in N=30 individuals with OCD

Device: low intensity transcranial focused ultrasound stimulation (TUS)

Interventions

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.

low intensity transcranial focused ultrasound stimulation (TUS); low intensity transcranial focused ultrasound stimulation (TUS) Sham

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Plymouth: lead

Study Sites (1)

Health

Plymouth, Devon, PL4 8AA, United Kingdom

Location

Related Links

• safety report for TUS use from expert consortium

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Elsa Fouragnan, PhD

CONTACT

7703335897; elsa.fouragnan@plymouth.ac.uk

Suraya Dunsford, PhD

CONTACT

01752585858; suraya.dunsford@plymouth.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Within subject, randomized, double-blind, sham-controlled trial

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 25, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): September 19, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: data will be available after analysis of primary and secondary outcomes are completed
• Access Criteria: anyone with access to the link to the data (OSF)

Locations

GB (1)