Targeted Circuit-Based Transcranial Focused Ultrasound Intervention for Obsessive-Compulsive Disorder TUS-OCD
NCT ID: NCT06722339
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2024-09-20
2026-09-20
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
DOUBLE
Study Groups
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TUS sham
double-blind, sham-controlled, crossover study in N=30 individuals with OCD
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.
TUS Active
double-blind, sham-controlled, crossover study in N=30 individuals with OCD
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
21 Years
55 Years
ALL
No
Sponsors
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University of Plymouth
OTHER
Responsible Party
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Elsa Fouragnan
Associate Professor
Principal Investigators
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Elsa F Fouragnan, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Plymouth
Locations
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Health
Plymouth, Devon, United Kingdom
Countries
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Related Links
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safety report for TUS use from expert consortium
Other Identifiers
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MR/T023007/1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024-4821-6128
Identifier Type: -
Identifier Source: org_study_id