Obsessive Compulsive Disorder (OCD)LIFU-OCDNCT07872917
Low-intensity Ultrasound for Individuals With Obsessive-compulsive Disorder
A study testing Low-intensity focused ultrasound (Active) in people with Obsessive Compulsive Disorder (OCD), run by University of Calgary at 1 site in Canada.
Trial summary
The goal of this clinical trial is to learn whether low-intensity focused ultrasound (LIFU), a non-invasive form of brain stimulation, can change brain activity and improve thinking and decision-making in adults with obsessive-compulsive disorder (OCD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD)
- What is being tested?
- Low-intensity focused ultrasound (Active)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2026to 31 Mar 2028
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary psychiatric diagnosis of OCD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR).
- A Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of ≥8.
- Able to provide informed consent, attend study visits, and complete study questionnaires.
- Eligible to undergo magnetic resonance imaging (MRI).
Who cannot join
- Participants with standard contraindications to MRI, such as non-MRI-compatible implanted metallic devices (e.g., cardiac pacemakers), size limitations, or other standard MRI contraindications.
- Participants unable to communicate with the investigator or study staff.
- Legal incapacity or diminished legal capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Novel Neuromodulation With Low-intensity Ultrasound (LIFU) for Individuals With Obsessive-compulsive Disorder (LIFU-OCD)
The goal of this clinical trial is to learn whether low-intensity focused ultrasound (LIFU), a non-invasive form of brain stimulation, can change brain activity and improve thinking and decision-making in adults with obsessive-compulsive disorder (OCD). The main questions it aims to answer are:
Can active LIFU change activity in brain pathways involved in OCD? Can active LIFU improve the ability to control thoughts and actions?
Read more
Researchers will compare active LIFU with sham LIFU to see whether active LIFU causes changes in brain activity and performance on behavioral tasks.
Participants will:
Complete questionnaires and behavioral tasks. Have magnetic resonance imaging (MRI) scans to measure brain activity and identify the area to receive LIFU.
Receive both active and sham LIFU on separate visits. Have MRI scans and complete behavioral tasks after each LIFU session. Complete assessments of OCD symptoms, safety, and possible side effects.
Read the detailed description
Obsessive-compulsive disorder (OCD) is a mental health condition characterized by unwanted and difficult-to-control thoughts, images, or urges, often accompanied by repeated behaviors or mental acts. OCD can cause substantial problems in daily life and reduce quality of life. Current treatments include medication and cognitive behavioral therapy, but many people with OCD do not achieve remission. Therefore, there is a need to develop new treatment approaches.
Research using brain imaging suggests that OCD is associated with abnormal activity in a network of connected brain regions called the cortico-striato-thalamo-cortical (CSTC) circuit. The anterior limb of the internal capsule (ALIC) is an important pathway within this circuit and connects several brain regions involved in OCD. The ALIC has therefore been used as a target for treatments that directly change brain activity in people with severe OCD.
Low-intensity focused ultrasound (LIFU) is a non-invasive brain stimulation method that uses focused ultrasound waves to change brain activity. Unlike some other non-invasive brain stimulation methods, LIFU can reach areas deep in the brain with a high degree of precision. This study will investigate whether LIFU targeting the ALIC can change brain activity and cognitive function in people with OCD.
This is a pilot exploratory clinical trial using a randomized crossover design. Each participant will receive both active and sham LIFU on separate study visits, with the order determined randomly. This design allows the effects of active LIFU to be compared with sham LIFU within the same participant.
Before LIFU, participants will undergo magnetic resonance imaging (MRI). Diffusion MRI will be used to examine brain connections and identify an individualized target within the ALIC for each participant. Computer simulation will also be used to plan how the ultrasound will reach the selected target.
Brain imaging will be performed before and after LIFU to examine changes in communication between brain regions. Participants will also complete behavioral tasks that measure cognitive control and impulsivity. Clinical symptoms and possible side effects will be assessed during the study.
The main purpose of this study is to determine whether active LIFU can change brain connectivity related to OCD and improve cognitive control compared with sham LIFU. The study will also collect preliminary information about changes in OCD symptoms and the safety and tolerability of LIFU. The findings may help determine whether this approach should be investigated further as a possible non-invasive treatment for OCD.
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Being tested
- Low-intensity focused ultrasound (Active), Low-intensity focused ultrasound (Sham)
- Keywords
- Obsessive compulsive disorder, Low-intensity focused ultrasound, Neuromodulation, Magnetic resonance imaging, Cognitive control
- 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 focused ultrasound (Active)Device
Low-intensity focused ultrasound (LIFU) will be delivered using an in-house system with a 128-element focused-ultrasound array operating at 500 kHz. The stimulation parameters are a pulse repetition frequency of 100 Hz, pulse duration of 1 ms, duty cycle of 10%, and pulse train duration of 90 seconds. LIFU will be delivered to an individualized target within the anterior limb of the internal capsule (ALIC) that has the strongest connection to the prefrontal cortex, identified using diffusion MRI and probabilistic tractography. Sham LIFU will be delivered during the sham condition.
Low-intensity focused ultrasound (Sham)Device
Sham LIFU will be delivered to the third ventricle using the same LIFU system.
| Study group | Role | What they receive |
|---|---|---|
| Active LIFU Followed by Sham LIFU | Experimental | Participants will receive active LIFU during the first stimulation visit, followed by sham LIFU during the second stimulation visit one week later. Receives: Device: Low-intensity focused ultrasound (Active); Device: Low-intensity focused ultrasound (Sham) |
| Sham LIFU Followed by Active LIFU | Experimental | Participants will receive sham LIFU during the first stimulation visit, followed by active LIFU during the second stimulation visit one week later. Receives: Device: Low-intensity focused ultrasound (Active); Device: Low-intensity focused ultrasound (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in functional connectivity between the ALIC and prefrontal cortex
Resting-state functional MRI will be used to measure functional connectivity between the anterior limb of the internal capsule (ALIC) and the prefrontal cortex. Functional connectivity will be quantified as a standardized coefficient between the ALIC and the prefrontal cortex. The outcome will be the change in functional connectivity from baseline to immediately after LIFU. Changes following active and sham LIFU will be compared.
Measured: Baseline and immediately after each LIFU session (sessions approximately 1 week apart).
Change in reaction time on the Multi-Source Interference Task (MSIT)
Reaction time (milliseconds) will be measured during the MSIT to assess cognitive control. The outcome will be the change in reaction time from baseline to immediately after LIFU. Changes following active LIFU will be compared with changes following sham LIFU.
Measured: Baseline and immediately after each LIFU session (sessions approximately 1 week apart).
Change in accuracy on the Multi-Source Interference Task (MSIT)
Accuracy (percentage) will be measured during the MSIT to assess cognitive control. The outcome will be the change in accuracy from baseline to immediately after LIFU. Changes following active LIFU will be compared with changes following sham LIFU.
Measured: Baseline and immediately after each LIFU session (sessions approximately 1 week apart).
Secondary outcomes (7)
Change in BOLD activation in the prefrontal cortex during the Multi-Source Interference Task (MSIT)
Task-based functional MRI will be used to measure blood oxygen level-dependent (BOLD) activation within the prefrontal cortex during the MSIT. BOLD activation will be quantified using a standardized measure. The outcome will be the change in BOLD activation from baseline to immediately after LIFU. Changes following active and sham LIFU will be compared.
Measured: Baseline and immediately after each LIFU session (sessions approximately 1 week apart).
Changes in probability of correct choice on the Information Sampling Task (IST)
The probability of making a correct choice will be measured during the IST to assess decision-making and impulsivity. The outcome will be the change in the probability of making a correct choice from baseline to immediately after LIFU. Changes following active LIFU will be compared with changes following sham LIFU.
Measured: Baseline and immediately after each LIFU session (sessions approximately 1 week apart).
Changes in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score
OCD symptom severity will be assessed using Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Changes in Y-BOCS scores will be compared between active and sham LIFU conditions.
Measured: Baseline and 1 week after each LIFU session.
Changes in Overall Anxiety Severity and Impairment Scale (OASIS) score
Anxiety severity will be assessed using the Overall Anxiety Severity and Impairment Scale (OASIS). Changes in OASIS scores will be compared between active and sham LIFU conditions.
Measured: Baseline and 1 week after each LIFU session.
Changes in Patient Health Questionnaire-9 (PHQ-9) score
Depression severity will be assessed using Patient Health Questionnaire-9 (PHQ-9). Changes in PHQ-9 scores will be compared between active and sham LIFU conditions.
Measured: Baseline and 1 week after each LIFU session.
Changes in Ruminative Responses Scale (RRS) score
Rumination severity will be assessed using Ruminative Responses Scale (RRS). Changes in RRS scores will be compared between active and sham LIFU conditions.
Measured: Baseline and 1 week after each LIFU session.
Incidence of adverse events
Adverse events and side effects will be assessed throughout the study, from the first LIFU session to 1 week after the final LIFU session. The proportion of participants experiencing adverse events (percentage) will be recorded and compared between active and sham LIFU conditions. Adverse events will be categorized according to severity and relationship to the procedure and device.
Measured: From the first LIFU session to 1 week after the final LIFU session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Hotchkiss Brain Institute, University of Calgary
- Responsible party
- Sponsor
- Investigators
- Kiss HT Kiss, Professor, Principal investigator, University of Calgary, Cumming School of Medicine, Department of Clinical Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872917
- Sponsor's protocol ID
- REB26-1371
- Acronym
- LIFU-OCD
- Status last verified
- Aug 2026
- First submitted
- 1 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There are currently no plans to use the data for future research beyond the purposes of this study.This study will not create a research database or registry for future research use. De-identified studydata will be retained indefinitely in accordance with the study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Neuromodulation With Low-intensity Ultrasound (LIFU) for Individuals With Obsessive-compulsive Disorder (LIFU-OCD)
- ClinicalTrials.gov ID
- NCT07872917
- Acronym / sponsor ID
- LIFU-OCD / REB26-1371
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Keywords
- Obsessive compulsive disorder, Low-intensity focused ultrasound, Neuromodulation, Magnetic resonance imaging, Cognitive control
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Hotchkiss Brain Institute, University of Calgary
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 14 Oct 2026 (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.
The goal of this clinical trial is to learn whether low-intensity focused ultrasound (LIFU), a non-invasive form of brain stimulation, can change brain activity and improve thinking and decision-making in adults with obsessive-compulsive disorder (OCD). The main questions it aims to answer are:
Can active LIFU change activity in brain pathways involved in OCD? Can active LIFU improve the ability to control thoughts and actions?
Researchers will compare active LIFU with sham LIFU to see whether active LIFU causes changes in brain activity and performance on behavioral tasks.
Participants will:
Complete questionnaires and behavioral tasks. Have magnetic resonance imaging (MRI) scans to measure brain activity and identify the area to receive LIFU.
Receive both active and sham LIFU on separate visits. Have MRI scans and complete behavioral tasks after each LIFU session. Complete assessments of OCD symptoms, safety, and possible side effects.
Detailed description
Obsessive-compulsive disorder (OCD) is a mental health condition characterized by unwanted and difficult-to-control thoughts, images, or urges, often accompanied by repeated behaviors or mental acts. OCD can cause substantial problems in daily life and reduce quality of life. Current treatments include medication and cognitive behavioral therapy, but many people with OCD do not achieve remission. Therefore, there is a need to develop new treatment approaches.
Research using brain imaging suggests that OCD is associated with abnormal activity in a network of connected brain regions called the cortico-striato-thalamo-cortical (CSTC) circuit. The anterior limb of the internal capsule (ALIC) is an important pathway within this circuit and connects several brain regions involved in OCD. The ALIC has therefore been used as a target for treatments that directly change brain activity in people with severe OCD.
Low-intensity focused ultrasound (LIFU) is a non-invasive brain stimulation method that uses focused ultrasound waves to change brain activity. Unlike some other non-invasive brain stimulation methods, LIFU can reach areas deep in the brain with a high degree of precision. This study will investigate whether LIFU targeting the ALIC can change brain activity and cognitive function in people with OCD.
This is a pilot exploratory clinical trial using a randomized crossover design. Each participant will receive both active and sham LIFU on separate study visits, with the order determined randomly. This design allows the effects of active LIFU to be compared with sham LIFU within the same participant.
Before LIFU, participants will undergo magnetic resonance imaging (MRI). Diffusion MRI will be used to examine brain connections and identify an individualized target within the ALIC for each participant. Computer simulation will also be used to plan how the ultrasound will reach the selected target.
Brain imaging will be performed before and after LIFU to examine changes in communication between brain regions. Participants will also complete behavioral tasks that measure cognitive control and impulsivity. Clinical symptoms and possible side effects will be assessed during the study.
The main purpose of this study is to determine whether active LIFU can change brain connectivity related to OCD and improve cognitive control compared with sham LIFU. The study will also collect preliminary information about changes in OCD symptoms and the safety and tolerability of LIFU. The findings may help determine whether this approach should be investigated further as a possible non-invasive treatment for OCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active LIFU Followed by Sham LIFU | Experimental | Device: Low-intensity focused ultrasound (Active), Device: Low-intensity focused ultrasound (Sham)Participants will receive active LIFU during the first stimulation visit, followed by sham LIFU during the second stimulation visit one week later. |
| Sham LIFU Followed by Active LIFU | Experimental | Device: Low-intensity focused ultrasound (Active), Device: Low-intensity focused ultrasound (Sham)Participants will receive sham LIFU during the first stimulation visit, followed by active LIFU during the second stimulation visit one week later. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary psychiatric diagnosis of OCD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR).
- A Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of ≥8.
- Able to provide informed consent, attend study visits, and complete study questionnaires.
- Eligible to undergo magnetic resonance imaging (MRI).
Key exclusion criteria (3 listed)
- Participants with standard contraindications to MRI, such as non-MRI-compatible implanted metallic devices (e.g., cardiac pacemakers), size limitations, or other standard MRI contraindications.
- Participants unable to communicate with the investigator or study staff.
- Legal incapacity or diminished legal capacity.
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 focused ultrasound (Active)Low-intensity focused ultrasound (LIFU) will be delivered using an in-house system with a 128-element focused-ultrasound array operating at 500 kHz. The stimulation parameters are a pulse repetition frequency of 100 Hz, pulse duration of 1 ms, duty cycle of 10%, and pulse train duration of 90 seconds. LIFU will be delivered to an individualized target within the anterior limb of the internal capsule (ALIC) that has the strongest connection to the prefrontal cortex, identified using diffusion MRI and probabilistic tractography. Sham LIFU will be delivered during the sham condition. | Device | Active LIFU Followed by Sham LIFU, Sham LIFU Followed by Active LIFU |
| Low-intensity focused ultrasound (Sham)Sham LIFU will be delivered to the third ventricle using the same LIFU system. | Device | Active LIFU Followed by Sham LIFU, Sham LIFU Followed by Active LIFU |
Primary outcome
Changes in functional connectivity between the ALIC and prefrontal cortex
Time frame: Baseline and immediately after each LIFU session (sessions approximately 1 week apart).
Resting-state functional MRI will be used to measure functional connectivity between the anterior limb of the internal capsule (ALIC) and the prefrontal cortex. Functional connectivity will be quantified as a standardized coefficient between the ALIC and the prefrontal cortex. The outcome will be the change in functional connectivity from baseline to immediately after LIFU. Changes following active and sham LIFU will be compared.
Change in reaction time on the Multi-Source Interference Task (MSIT)
Time frame: Baseline and immediately after each LIFU session (sessions approximately 1 week apart).
Reaction time (milliseconds) will be measured during the MSIT to assess cognitive control. The outcome will be the change in reaction time from baseline to immediately after LIFU. Changes following active LIFU will be compared with changes following sham LIFU.
Change in accuracy on the Multi-Source Interference Task (MSIT)
Time frame: Baseline and immediately after each LIFU session (sessions approximately 1 week apart).
Accuracy (percentage) will be measured during the MSIT to assess cognitive control. The outcome will be the change in accuracy from baseline to immediately after LIFU. Changes following active LIFU will be compared with changes following sham LIFU.
7 secondary outcomes
Change in BOLD activation in the prefrontal cortex during the Multi-Source Interference Task (MSIT)
Time frame: Baseline and immediately after each LIFU session (sessions approximately 1 week apart).
Changes in probability of correct choice on the Information Sampling Task (IST)
Time frame: Baseline and immediately after each LIFU session (sessions approximately 1 week apart).
Changes in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score
Time frame: Baseline and 1 week after each LIFU session.
Changes in Overall Anxiety Severity and Impairment Scale (OASIS) score
Time frame: Baseline and 1 week after each LIFU session.
Changes in Patient Health Questionnaire-9 (PHQ-9) score
Time frame: Baseline and 1 week after each LIFU session.
Changes in Ruminative Responses Scale (RRS) score
Time frame: Baseline and 1 week after each LIFU session.
Incidence of adverse events
Time frame: From the first LIFU session to 1 week after the final LIFU session.
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 14 Oct 2026.
- Individual participant dataSharing planned: Undecided. There are currently no plans to use the data for future research beyond the purposes of this study.This study will not create a research database or registry for future research use. De-identified studydata will be retained indefinitely in accordance with the study protocol.
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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.
Kiss HT Kiss, Professor principal investigator
University of Calgary, Cumming School of Medicine, Department of Clinical Neurosciences
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 focused ultrasound (Active) in people with Obsessive Compulsive Disorder (OCD), run by University of Calgary at 1 site in Canada.
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 3 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: opening soon, as of the sponsor's last update on 14 Oct 2026. 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 Canada. 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?
Contact Yu Mimura, M.D., Ph.D. (403-220-2082, yu.mimura@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in functional connectivity between the ALIC and prefrontal cortex (time frame: Baseline and immediately after each LIFU session (sessions approximately 1 week apart).). The study lists 3 primary outcomes in all. 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 14 Oct 2026.