Obsessive-Compulsive DisorderTUS-OCDNCT06722339
Targeted Circuit-Based Transcranial Focused Ultrasound Intervention for Obsessive-Compulsive Disorder TUS-OCD
A study testing low intensity transcranial focused ultrasound stimulation (TUS) in people with Obsessive-Compulsive Disorder, run by University of Plymouth at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- low intensity transcranial focused ultrasound stimulation (TUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Sep 2024to 20 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- low intensity transcranial focused ultrasound stimulation (TUS)
- Keywords
- focused ultrasound, TUS, neuromodulation, OCD
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low intensity transcranial focused ultrasound stimulation (TUS)Device
Also called low intensity focused ultrasound (LIFU)
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.
| Study group | Role | What they receive |
|---|---|---|
| TUS sham | Other | double-blind, sham-controlled, crossover study in N=30 individuals with OCD Receives: Device: low intensity transcranial focused ultrasound stimulation (TUS) |
| TUS Active | Other | double-blind, sham-controlled, crossover study in N=30 individuals with OCD Receives: Device: low intensity transcranial focused ultrasound stimulation (TUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
number of adverse events
Measured: Immediately after TUS session; one day and one week after TUS. Same for sham, to compare the TUS active and sham.
Secondary outcomes (1)
reduction in OCD symptoms
numerical OCD symptoms rating scale
Measured: immediately prior to TUS sessions, within 1 hour post TUS and every day that follow TUS for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start20 Sep 2024
- Primary completion19 Sep 2025 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Within subject, randomized, double-blind, sham-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsa Fouragnan, University of Plymouth
- Investigators
- Elsa F Fouragnan, Ph.D., Principal investigator, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722339
- Sponsor's protocol ID
- 2024-4821-6128
- Other IDs
- MR/T023007/1
- Acronym
- TUS-OCD
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous behavioral data upon publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Circuit-Based Transcranial Focused Ultrasound Intervention for Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT06722339
- Acronym / sponsor ID
- TUS-OCD / 2024-4821-6128
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- focused ultrasound, TUS, neuromodulation, OCD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 19 Sep 2025 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Within subject, randomized, double-blind, sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| TUS sham | Other | Device: low intensity transcranial focused ultrasound stimulation (TUS)double-blind, sham-controlled, crossover study in N=30 individuals with OCD |
| TUS Active | Other | Device: low intensity transcranial focused ultrasound stimulation (TUS)double-blind, sham-controlled, crossover study in N=30 individuals with OCD |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (25 listed)
- The participant may not enter the trial if ANY of the following apply.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low intensity transcranial focused ultrasound stimulation (TUS)Also: low intensity focused ultrasound (LIFU)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. | Device | TUS Active, TUS sham |
Primary outcome
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
1 secondary outcome
reduction in OCD symptoms
Time frame: immediately prior to TUS sessions, within 1 hour post TUS and every day that follow TUS for 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- safety report for TUS use from expert consortiumLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymous behavioral data upon publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elsa F Fouragnan, Ph.D. principal investigator
University of Plymouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low intensity transcranial focused ultrasound stimulation (TUS) in people with Obsessive-Compulsive Disorder, run by University of Plymouth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.