Obsessive Compulsive Disorder (OCD)NCT07558148
OCD LIFU Target Engagement
A study testing Low Intensity Focused Ultrasound in people with Obsessive Compulsive Disorder (OCD), run by University of Pennsylvania at 1 site in United States.
Trial summary
The investigators will conduct a pilot study to evaluate the safety and feasibility of low-intensity focused ultrasound on obsessive-compulsive disorder (OCD) symptoms when delivered to subcortical brain targets. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD)
- What is being tested?
- Low Intensity Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2026to 19 May 2027
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unable to undergo MRI scan
- Presence of metallic implants or devices or tattoos
- Claustrophobia or severe anxiety
- Inability to remain still for duration of scan
- Inability to fit and wear the ATTN201 device for the entire
Show all 15Show fewer
- Hearing loss that, in the opinion of the Principal Investigator, an audiologist, or a treating physician, is likely to affect the subject's ability to comply with all of the requirements of the study, or may affect the integrity of the study data
- Pregnancy - this is an exclusion criterion because we will be intentionally increasing anxiety in participants to evaluate optimal strategies to provoke distress and then promote relaxation
- Any past or present medical condition, disease, disorder, or injury that, in the opinion of the Principal Investigator, may reduce or hinder the subject's ability to fully comply with all study requirements for the duration of the study or may impact, compromise, or affect the integrity of the data or results of the study.
- Have a previous injury or surgery which could affect the nerve distribution
- Have nerve damage (neuropathy)
- Have a diagnosed neuromuscular disorder
- Have a pacemaker
- Have a history of skin allergies, psoriasis eczema, dermatitis, or other skin inflammation conditions
- Compulsions cannot be completely mental or verbal actions, such as repeating words, counting objects, or performing mental rituals, and cannot involve only facial muscles/actions such as blinking or staring
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Giovanna Rocchio contact
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Rishi Suresh, 215-746-8901, rishi.suresh1@pennmedicine.upenn.edu
Giovanna Rocchio, giovanna.rocchio@pennmedicine.upenn.edu
About this study
Official title: Pilot Study to Investigate Brain Targets for Neuromodulation in Obsessive-compulsive Disorder
The investigators will conduct a pilot study to evaluate the safety and feasibility of low-intensity focused ultrasound on obsessive-compulsive disorder (OCD) symptoms when delivered to subcortical brain targets. The investigators will use the ATTN201 device to deliver single sessions of unfocused and focused ultrasound to up to three brain targets over 4 study visits and assess the intervention through self-rated scales of OCD symptoms.
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Being tested
- Low Intensity Focused Ultrasound
- Keywords
- OCD, LIFU
- 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 UltrasoundDevice
Also called LIFU
Low-intensity focused ultrasound (LIFU) will be administered using the Attune ATTN201 device. This intervention is characterized by a multifocal approach targeting three specific subcortical regions: the subthalamic nucleus (STN), the dorsal anterior cingulate cortex (dACC), and the ventral striatum (VS+). Unlike clinical treatment trials, this is a target-engagement pilot study where each participant receives single sessions of sonication at these specific coordinates to evaluate acute physiological and symptomatic changes. The intervention includes a within-subject sham-controlled component, where the device is positioned identically but no ultrasound energy is delivered.
| Study group | Role | What they receive |
|---|---|---|
| LIFU Target Engagement Group | Experimental | Participants in this single experimental group will undergo a series of low-intensity focused ultrasound (LIFU) sessions to evaluate safety and target engagement. Each participant will receive active LIFU stimulation at up to three personalized corticostriatal brain targets.
The study utilizes a within-subject, sham-controlled design where participants receive both active LIFU and sham (placebo) stimulation across different sessions to compare physiological and clinical responses. Receives: Device: Low Intensity Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symptom Intensity through VAS score
This outcome evaluates the change in symptom intensity using Visual Analog Scales (VAS) scores. VAS include questions regarding urges to compulse/resist compulsions and subjective units of distress (SUDs), measure the intensity of a patient's impulse to carry out or control and inhibit these compulsions, and the amount of distress they feel, and are on a scale between 0-100, where higher scores signify greater symptom severity.
Measured: From the first visit (Visit 1) through the final visit (Visit 10), approximately 6 weeks.
Changes in Imaging between Pre- and Post-Intervention
This outcome measure evaluates safety and efficacy through neuroimaging conducted prior to and following the intervention. These measures are intended to assess potential effects and target engagement associated with LIFU. Efficacy measures will include changes in MRI-derived metrics (e.g., functional connectivity and/or regional activation in predefined regions of interest associated with the stimulation target). Safety is assessed by the presence of new or worsening structural abnormalities, including edema, hemorrhage, or tissue injury.
Measured: Before the first visit (Visit 1) and after the final visit (Visit 10), approximately 6 weeks
Incidence of Adverse Events Assesed by Symptom Checklist
This outcome measure evaluates the incidence and severity of adverse events using a structured symptomatic checklist survey administered throughout the study period. The checklist captures the presence, frequency, and severity of potential adverse symptoms. Adverse events will be categorized by type, relatedness, and severity.
Measured: Immediately after each intervention session and up to 24 hours post-intervention, assessed across the intervention period (Visits 6-9).
Secondary outcomes (5)
Physiological Changes Measured by EMG
This outcome measure evaluates changes in muscle activity using surface electromyography (EMG) recorded from the forearm during sessions. EMG signals will be collected continuously and processed using standardized pipelines. Metrics will include various features (e.g., SNR (dB)) over defined time windows. Change in muscle activity will be assessed by comparing pre-sonication values to post-sonication values.
Measured: Baseline through end of intervention period (Visits 2-9), with EMG data collected at every in-person visit, approximately 4 weeks.
Change in Y-BOCS score after sonication
This outcome measures changes in Obsessive-Compulsive symptom severity using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), administered by a trained clinician. Scores range from 0-40, with higher scores representing greater symptom severity.
Measured: From the first baseline visit (Visit 1) through the final visit (Visit 10).
Change in Acceleration Measured by IMU
This outcome measure evaluates changes in forearm movement amplitude using inertial measurement unit (IMU)-derived acceleration data. Acceleration (m/s²) will be recorded continuously from a microcontroller-based IMU placed on the participant's forearm during in-person sessions and processed using standardized signal processing pipelines. Change in movement amplitude will be assessed by comparing pre-sonication and post-sonication values.
Measured: Baseline through end of intervention period (Visits 2-9), with IMU data collected at every in-person visit, approximately 4 weeks.
Change in Angular Velocity Measured by IMU
This outcome measure evaluates changes in forearm rotational movement using inertial measurement unit (IMU)-derived angular velocity data. Angular velocity (°/s) will be recorded continuously from a microcontroller-based IMU placed on the participant's forearm during in-person sessions and processed using standardized signal processing pipelines. Change in rotational movement will be assessed by comparing pre-sonication and post-sonication values.
Measured: Baseline through end of intervention period (Visits 2-9), with IMU data collected at every in-person visit, approximately 4 weeks.
Change in Heart Rate Assessed by Photoplethysmography (PPG)
This outcome evaluates changes in heart rate activity using photoplethysmography (PPG) recorded during sessions. PPG signals will be collected from sensors placed on the participant and processed using standardized pipelines. Changes in physiological response will be assessed by comparing pre to post-sonication values.
Measured: Baseline through end of intervention period (Visits 2-9), with PPG data collected at every in-person visit, approximately 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start4 Mar 2026
- Primary completion19 May 2027 (estimated)
- Study completion19 May 2027 (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.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Attune Neurosciences Inc
- Responsible party
- Principal investigator, Katherine Scangos, University of Pennsylvania
- Investigators
- Katherine Scangos, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558148
- Sponsor's protocol ID
- 25-0707
- Status last verified
- Sep 2026
- First submitted
- 25 Mar 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with outside researchers at this time to ensure the protection of participant privacy and to maintain strict compliance with the University of Pennsylvania Institutional Review Board (IRB) approved protocol.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate Brain Targets for Neuromodulation in Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT07558148
- Acronym / sponsor ID
- 25-0707
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Keywords
- OCD, LIFU
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Attune Neurosciences Inc
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 19 May 2027 (estimated)
- Study completion
- 19 May 2027 (estimated)
- First posted
- 30 Apr 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 investigators will conduct a pilot study to evaluate the safety and feasibility of low-intensity focused ultrasound on obsessive-compulsive disorder (OCD) symptoms when delivered to subcortical brain targets. The investigators will use the ATTN201 device to deliver single sessions of unfocused and focused ultrasound to up to three brain targets over 4 study visits and assess the intervention through self-rated scales of OCD symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LIFU Target Engagement Group | Experimental | Device: Low Intensity Focused UltrasoundParticipants in this single experimental group will undergo a series of low-intensity focused ultrasound (LIFU) sessions to evaluate safety and target engagement. Each participant will receive active LIFU stimulation at up to three personalized corticostriatal brain targets. The study utilizes a within-subject, sham-controlled design where participants receive both active LIFU and sham (placebo) stimulation across different sessions to compare physiological and clinical responses. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unable to undergo MRI scan
- Inability to fit and wear the ATTN201 device for the entire
- Hearing loss that, in the opinion of the Principal Investigator, an audiologist, or a treating physician, is likely to affect the subject's ability to comply with all of the requirements of the study, or may affect the integrity of the study data
- Pregnancy - this is an exclusion criterion because we will be intentionally increasing anxiety in participants to evaluate optimal strategies to provoke distress and then promote relaxation
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 UltrasoundAlso: LIFULow-intensity focused ultrasound (LIFU) will be administered using the Attune ATTN201 device. This intervention is characterized by a multifocal approach targeting three specific subcortical regions: the subthalamic nucleus (STN), the dorsal anterior cingulate cortex (dACC), and the ventral striatum (VS+). Unlike clinical treatment trials, this is a target-engagement pilot study where each participant receives single sessions of sonication at these specific coordinates to evaluate acute physiological and symptomatic changes. The intervention includes a within-subject sham-controlled component, where the device is positioned identically but no ultrasound energy is delivered. | Device | LIFU Target Engagement Group |
Primary outcome
Change in Symptom Intensity through VAS score
Time frame: From the first visit (Visit 1) through the final visit (Visit 10), approximately 6 weeks.
This outcome evaluates the change in symptom intensity using Visual Analog Scales (VAS) scores. VAS include questions regarding urges to compulse/resist compulsions and subjective units of distress (SUDs), measure the intensity of a patient's impulse to carry out or control and inhibit these compulsions, and the amount of distress they feel, and are on a scale between 0-100, where higher scores signify greater symptom severity.
Changes in Imaging between Pre- and Post-Intervention
Time frame: Before the first visit (Visit 1) and after the final visit (Visit 10), approximately 6 weeks
This outcome measure evaluates safety and efficacy through neuroimaging conducted prior to and following the intervention. These measures are intended to assess potential effects and target engagement associated with LIFU. Efficacy measures will include changes in MRI-derived metrics (e.g., functional connectivity and/or regional activation in predefined regions of interest associated with the stimulation target). Safety is assessed by the presence of new or worsening structural abnormalities, including edema, hemorrhage, or tissue injury.
Incidence of Adverse Events Assesed by Symptom Checklist
Time frame: Immediately after each intervention session and up to 24 hours post-intervention, assessed across the intervention period (Visits 6-9).
This outcome measure evaluates the incidence and severity of adverse events using a structured symptomatic checklist survey administered throughout the study period. The checklist captures the presence, frequency, and severity of potential adverse symptoms. Adverse events will be categorized by type, relatedness, and severity.
5 secondary outcomes
Physiological Changes Measured by EMG
Time frame: Baseline through end of intervention period (Visits 2-9), with EMG data collected at every in-person visit, approximately 4 weeks.
Change in Y-BOCS score after sonication
Time frame: From the first baseline visit (Visit 1) through the final visit (Visit 10).
Change in Acceleration Measured by IMU
Time frame: Baseline through end of intervention period (Visits 2-9), with IMU data collected at every in-person visit, approximately 4 weeks.
Change in Angular Velocity Measured by IMU
Time frame: Baseline through end of intervention period (Visits 2-9), with IMU data collected at every in-person visit, approximately 4 weeks.
Change in Heart Rate Assessed by Photoplethysmography (PPG)
Time frame: Baseline through end of intervention period (Visits 2-9), with PPG data collected at every in-person visit, approximately 6 weeks.
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 1 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with outside researchers at this time to ensure the protection of participant privacy and to maintain strict compliance with the University of Pennsylvania Institutional Review Board (IRB) approved 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.
Giovanna Rocchio contact
Katherine Scangos, MD, PhD principal investigator
University of Pennsylvania
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 in people with Obsessive Compulsive Disorder (OCD), run by University of Pennsylvania at 1 site in United States.
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 0 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 1 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 United States. 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 Rishi Suresh, MD (215-746-8901, rishi.suresh1@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptom Intensity through VAS score (time frame: From the first visit (Visit 1) through the final visit (Visit 10), approximately 6 weeks.). 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 1 Oct 2026.