Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression

NCT07094789 | Recruiting

• 1 other identifier: 6702
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Treatment-Resistant Depression; Treatment-resistant Depression (TRD)

Keywords

Neuromodulation; Focused Ultrasound; Treatment-Resistant Depression; FUS; TRD; CSTC Circuit

Outcome Measures

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.

  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)

  Assessed at 2 weeks after first treatment and 2 and 4 weeks after second treatment.

Study Arms (1)

Focused Ultrasound Neuromodulation

EXPERIMENTAL

Participants will receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation targeting regions within the cortical-striatal-thalamic circuit (CSTC) implicated in treatment-resistant depression. Treatments will be spaced four weeks apart. All participants will receive the same intervention and will be followed for 4 weeks post-treatment to evaluate clinical outcomes, adverse events, and depression symptoms.

Device: Next Generation Dome Helmet (NGDH)

Interventions

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.

Focused Ultrasound Neuromodulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• On a stable regimen of psychiatric medications for at least 30 days prior to enrollment.
• Documented previous trial of at least two first-line antidepressant agents at adequate dose and duration, as assessed by two psychiatrists.
• Documented previous trial of cognitive behavioral therapy (CBT) or psychotherapy for MDD, sustained for at least 6 weeks.

You may not qualify if:

• 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.
• Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)
• Inability to reliably attend required screening, treatment, or follow-up appointments.
• Severe claustrophobia, as identified by the participant, that would prevent completion of MRI procedures.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Nir Lipsman, MD, PhD, FRCSC

CONTACT

(416)-480-6954; Nir.Lipsman@sunnybrook.ca

Anusha Baskaran, PhD

CONTACT

416-480-6100; anusha.baskaran@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)