Safety and feasibility of a next-generation dome helmet for neuromodulation in OCD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm study evaluating the safety and tolerability of transcranial focused ultrasound delivered with the Next Generation Dome Helmet (NGDH) in adults with OCD that has not responded to standard treatments. Participants receive two treatment sessions four weeks apart, with stimulation targeting key nodes of the cortico-striato-thalamo-cortical circuit. Outcomes include adverse events, OCD symptom severity, and quality of life to explore preliminary efficacy and feasibility. The study enrolls up to 20 participants at Sunnybrook Health Sciences Centre in Toronto.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Must be deemed to have the capacity to provide informed consent.
2. Age 18 to 85 years.
3. Diagnosis of obsessive-compulsive disorder according to DSM-5 criteria.
4. Yale-Brown Obsessive Compulsive Scale total score greater than 22.
5. 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.
6. Previous trial of at least two first-line antidepressant agents at an adequate dose and duration, as assessed by two psychiatrists.
7. Previous trial of cognitive behavioural therapy or psychotherapy for OCD for at least 6 weeks.

Exclusion Criteria:

1. Pregnant or intending to become pregnant during the study.
2. 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.
3. Known active seizure disorder or significant head injury with an imaging-confirmed lesion.
4. Unstable medical illness.
5. Not eligible for 3-Tesla MRI, such as due to an MRI-incompatible pacemaker or other implanted device.
6. Unable to reliably attend the required screening, treatment, and follow-up visits.
7. Severe claustrophobia that would prevent MRI scanning.
8. History of a bleeding disorder or coagulopathy.
9. 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

Where it's running

• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Nir Lipsman, MD, PHD, FRCSC, FAANS
• Email: Nir.Lipsman@sunnybrook.ca
• Phone: (416)-480-6954

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combining neurostimulation with emotion regulation training for emotional issues

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• Low-intensity focused ultrasound targeting the subthalamic nucleus for OCD

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• Focused ultrasound for mood and anxiety disorders

  This study tests whether repeated low-intensity focused ultrasound using the ATTN201 device can help people with subsyndromal to moderate depression, anxiety, or OCD.

  Recruiting Attune Neurosciences Inc · San Francisco, California and 1 other locations · NCT07851038

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.