Targeted Circuit-Based Transcranial Focused Ultrasound Intervention for Obsessive-Compulsive Disorder TUS-OCD (TUS-OCD)

Targeted Circuit-Based Transcranial Focused Ultrasound Intervention for Obsessive-Compulsive Disorder

This study explores the potential of transcranial ultrasound stimulation (TUS) as an innovative therapeutic approach for individuals with obsessive-compulsive disorder (OCD). By targeting specific brain regions associated with compulsive behaviors and anxiety, the researchers aim to assess the safety and efficacy of TUS in reducing symptoms and enhancing cognitive flexibility.

Study Overview

• Status: Active, not recruiting
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Device: low intensity transcranial focused ultrasound stimulation (TUS)

Detailed Description

Obsessive Compulsive Disorder (OCD) is a common and highly debilitating disorder with the manifestation of obsessions/compulsions and is associated with a significant impairment in social functioning and quality of life. Estimates show that the effects of OCD create an economic burden of £5 billion/year in the UK alone (Kochar et al. 2023). Novel interventions with greater efficacy in addressing the symptoms of OCD in patients, aiming to surpass the current standards of effectiveness and comprehensiveness in treatment outcomes are needed. Low-intensity transcranial focused ultrasound stimulation (TUS) is a promising emerging non-invasive brain stimulation technique which can neuromodulate any brain region with high spatial resolution.

The neural underpinning of OCD is thought to involve many prefrontal regions including the anterior cingulate cortex (ACC) but also deeper brain regions like the striatum (habit formation: Ahmari et al. 2017, Denys et al. 2013), the thalamus (Subirà et al. 2016) and the amygdala (overactivity: Fullana et al. 2020, Milad et al. 2013). TUS can focally induce changes in neuronal activity in both cortical and subcortical brain regions with incredibly high spatial resolution (Darmani et al. 2022). The current study will focus on targeting multiple regions playing a significant role in regulating various cognitive and repeated actions in OCD. We will assess safety and efficiency of TUS to different parts of the brain in alleviating OCD symptoms.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Plymouth, Devon, United Kingdom, PL4 8AA
      • Health

Participation Criteria

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 ≥ 17 on the Obsessive-Compulsive Inventory-Revised (OCI-R).
• 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 OCD)
• 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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.; Other Names: low intensity focused ultrasound (LIFU)
Other: TUS Active; 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 Names: low intensity focused ultrasound (LIFU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduction in OCD symptoms	numerical OCD symptoms rating scale	immediately prior to TUS sessions, within 1 hour post TUS and every day that follow TUS for 7 days

Collaborators and Investigators

• Sponsor: University of Plymouth
• Investigators: Principal Investigator: Elsa F Fouragnan, Ph.D., University of Plymouth

Publications and helpful links

Helpful Links

• safety report for TUS use from expert consortium

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Estimated): September 19, 2025
• Study Completion (Estimated): September 20, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: OCD; neuromodulation; focused ultrasound; TUS
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 2024-4821-6128; MR/T023007/1 (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