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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSunnybrook Health Sciences Centre

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Next Generation Dome Helmet (NGDH)

Treatment groups

20 Participants
are divided into 1 treatment group