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NCT Number: NCT07704632

Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)

This study evaluates the safety, feasibility, and preliminary efficacy of focused ultrasound (FUS) neuromodulation delivered using the Next Generation Dome Helmet (NGDH) in participants with treatment-refractory obsessive-compulsive disorder (OCD). Participants will undergo two study sessions, four weeks apart, involving active FUS neuromodulation targeting nodes of the cortico-striato-thalamo-cortical (CTSC) circuit. Outcomes include adverse events, changes in OCD symptom severity, and quality of life.

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Key information

Conditions

OCD Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder Obsessive-Compulsive Disorder (OCD)

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location status: Recruiting

Location contact

Anusha Baskaran, PhD

CONTACT

[email protected]

416-480-6100 ext. 61650

About this study

This study is designed as a prospective, single arm, nonrandomized study aiming to evaluate safety and tolerability of transcranial focused ultrasound neuromodulation targeting CTSC circuit nodes (including VC/VS, STN, ACC, OFC, and caudate nucleus).

Twenty participants with treatment-refractory OCD will be enrolled. Each participant will receive two treatment sessions (4 weeks apart)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be deemed to have the capacity to provide informed consent.
  • Age 18 to 85 years.
  • Diagnosis of obsessive-compulsive disorder according to DSM-5 criteria.
  • Yale-Brown Obsessive Compulsive Scale total score greater than 22.
  • If taking psychiatric medications, must be on a stable regimen for at least 30 days before enrollment. Psychiatric medications will be continued throughout the study.
  • Previous trial of at least two first-line antidepressant agents at an adequate dose and duration, as assessed by two psychiatrists.
  • Previous trial of cognitive behavioural therapy or psychotherapy for OCD for at least 6 weeks.

Exclusion criteria

  • Pregnant or intending to become pregnant during the study.
  • Substance use disorder, other than cannabis or nicotine use disorder, of moderate severity or greater, or where the substance is the primary substance of concern, according to DSM-5 criteria.
  • Known active seizure disorder or significant head injury with an imaging-confirmed lesion.
  • Unstable medical illness.
  • Not eligible for 3-Tesla MRI, such as due to an MRI-incompatible pacemaker or other implanted device.
  • Unable to reliably attend the required screening, treatment, and follow-up visits.
  • Severe claustrophobia that would prevent MRI scanning.
  • History of a bleeding disorder or coagulopathy.
  • Anticoagulant therapy or use of medications known to increase the risk of hemorrhage within the required washout period before treatment, including:
  • Antiplatelet agents or vitamin K antagonist anticoagulants within 7 days of treatment
  • Non-vitamin K oral anticoagulants within 72 hours of treatment
  • Heparin-derived compounds within 48 hours of treatment

Treatment and study plan

Next Generation Dome Helmet (NGDH)

Device

Participants will receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation, spaced four weeks apart, using the Next Generation Dome Helmet device. Treatments will target regions within the CSTC circuit identified by advanced MRI scans. Each session will include pre-treatment assessments, precise sonications of deep brain structures, real-time safety monitoring, and post-treatment imaging.

Primary outcomes

  1. Safety and Feasibility of FUS Neuromodulation in Participants With Treatment-Refractory Obsessive-Compulsive Disorder

    Time frame: Assessments will be conducted at the baseline visit; on the day of each of the two treatments; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.

    Assessment of the frequency and severity of adverse events associated with focused ultrasound neuromodulation in patients with treatment-refractory obsessive-compulsive disorder. Adverse events, including procedure-related complications and neurological events, will be documented and assessed.

Secondary outcomes

  1. Change in Obsessive-Compulsive Symptom Severity Measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Time frame: Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.

    Evaluate the effectiveness of FUS Neuromodulation in reducing obsessive-compulsive symptom severity using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The Y-BOCS is a clinician-administered scale assessing the severity of obsessive-compulsive symptoms. Total scores range from 0 to 40, with higher scores indicating greater symptom severity (0-7 subclinical, 8-15 mild, 16-23 moderate, 24-31 severe, and 32-40 extreme).

  2. Change in Quality of Life as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

    Time frame: Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.

    Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The Q-LES-Q is a self-report measure assessing quality of life across multiple domains. Total scores are typically transformed into a percentage of the maximum possible score, with higher percentages indicating greater life satisfaction and functioning. Change from baseline will be evaluated at each assessment time point.

  3. Change in Obsessive-Compulsive Symptoms as Measured by the Obsessive Compulsive Inventory (OCI)

    Time frame: Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.

    The Obsessive Compulsive Inventory is a self-report measure used to assess obsessive-compulsive symptoms. Higher scores indicate greater symptom severity. Change from baseline will be evaluated at each assessment time point.

  4. Change in Anxiety Symptoms as Measured by the Beck Anxiety Inventory (BAI)

    Time frame: Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.

    The Beck Anxiety Inventory (BAI) is a 21-item self-report scale assessing the severity of anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating greater anxiety severity (0-7 minimal, 8-15 mild, 16-25 moderate, and 26-63 severe anxiety). Change from baseline will be evaluated at each assessment time point.

  5. Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.

    The GAD-7 is a 7-item self-report questionnaire used to assess generalized anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity. Scores of 5, 10, and 15 represent commonly used thresholds for mild, moderate, and severe anxiety, respectively. Change from baseline will be evaluated at each assessment time point.

  6. Change in Patient-Reported Outcomes Using Likert Scales (1-9)

    Time frame: Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.

    A brief set of 1-9 Likert scales will be used to assess patient-reported symptoms and subjective experiences. Scores range from 1 to 9, with higher scores indicating greater symptom severity or impact. Change from baseline will be evaluated at each assessment time point.

  7. Change in Depressive Symptoms as Measured by the 17-Item Hamilton Depression Rating Scale (HAMD-17)

    Time frame: Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.

    The HAMD-17 is a clinician-administered scale used to assess the severity of depressive symptoms. Total scores range from 0 to 52, with higher scores indicating greater depressive symptom severity. Change from baseline will be evaluated at each assessment time point.

Study contacts

Contact information is provided by the study sponsor or research team.

Anusha Baskaran, PhD

CONTACT

[email protected]

416-480-6100 ext. 61650

Nir Lipsman, MD, PHD, FRCSC, FAANS

CONTACT

[email protected]

(416)-480-6954

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

Assessment of Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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