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Clinical Trials/NCT06722339
NCT06722339
Active, not recruiting
Not Applicable

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

University of Plymouth1 site in 1 country30 target enrollmentSeptember 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obsessive-Compulsive Disorder
Sponsor
University of Plymouth
Enrollment
30
Locations
1
Primary Endpoint
Incidence of Treatment-Emergent Adverse Events
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2024
End Date
September 20, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elsa Fouragnan

Associate Professor

University of Plymouth

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • reduction in OCD symptoms(immediately prior to TUS sessions, within 1 hour post TUS and every day that follow TUS for 7 days)

Study Sites (1)

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