Towards a Targeted Ultrasound Neuromodulation Intervention for Alcohol Abuse Disorders

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorUniversity of Plymouth

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: low intensity transcranial focused ultrasound stimulation (TUS)Other 1 intervention
Group B: low intensity transcranial focused ultrasound stimulation (TUS) ShamOther 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events

number of 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.

Secondary outcomes

1

Change in AUD symptoms

numerical AUD symptoms rating scale and Alcohol Consumptions

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: