Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSunnybrook Health Sciences Centre
About this trial
The goal of this clinical trial is to evaluate the safety and initial effectiveness of Magnetic Resonance-guided focused ultrasound neuromodulation using the Next Generation Dome Helmet (NGDH) device in patients with treatment-resistant depression. This is a prospective, single-arm, non-randomized study.
Participants will:
* Undergo two focused ultrasound treatment sessions targeting nodes of the cortical-striatal-thalamic circuit (CSTC) , spaced four weeks apart. * Return for follow-up visits at 24 hours, 2 weeks, and 4 weeks after each treatment session, during which clinical scales and imaging assessments will be conducted to monitor safety and clinical effects.
Eligibility criteria
Qualifiers
Deemed to have the capacity to provide informed consent.
Aged between 18 and 65 years.
Diagnosis of major depressive disorder (MDD) according to DSM-5 criteria.
Total score >20 on the Hamilton Depression Rating Scale (HAMD-17).
Disqualifiers
Pregnant or intending to become pregnant during the study period.
Diagnosis of a substance use disorder (excluding cannabis or nicotine) of moderate severity or greater, or when the substance is the primary focus of treatment, based on DSM-5 criteria.
Known active seizure disorder, significant head injury with an imaging-verified 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 groupSponsors and collaborators
Source ClinicalTrials.gov