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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Next Generation Dome Helmet (NGDH)
DeviceParticipants 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Focused Ultrasound NeuromodulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients with Treatment-Resistant Depression
Assessment of the frequency and severity of adverse events associated with focused ultrasound neuromodulation in patients with treatment-resistant depression using the Next Generation Dome Helmet device. Adverse events, including procedure-related complications and neurological events, will be documented and assessed throughout the study period.
Time frame
Assessments will be conducted at the baseline visit, 24 hours after the first treatment, 2 weeks after the first treatment, 24 hours after the second treatment, and at 2 and 4 weeks following the second treatment.Secondary outcomes
1
Clinical Efficacy - Change in Depressive Symptoms measured by Hamilton Depression Rating Scale (HAMD-17)
Clinical efficacy will be evaluated by analyzing changes in symptom scores using repeated-measures analysis of variance. The primary measure of clinical efficacy will be the Hamilton Depression Rating Scale (HAMD-17) score.
Time frame
Assessed at 2 weeks after first treatment and 2 and 4 weeks after second treatment.Sponsors and contacts
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Source ClinicalTrials.gov