Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression

NCT ID: NCT07094789

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-11
• Study Completion Date: 2027-08-31

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.

Detailed Description

A total of 20 participants with treatment-resistant depression will be enrolled and treated in this study. Participants will be recruited through local psychiatric practices, referrals from participating institutions, and external referrals, including both physician and self-referrals.

Eligibility will be assessed during a dedicated screening appointment conducted by the study coordinator in collaboration with a study-affiliated physician. The anticipated enrollment period is approximately two years, beginning from the date of first patient enrollment to the enrollment of the final participant.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Focused Ultrasound Neuromodulation

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.

Group Type: EXPERIMENTAL

Next Generation Dome Helmet (NGDH)

Intervention Type: 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.

Interventions

Next Generation Dome Helmet (NGDH)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Deemed to have the capacity to provide informed consent.

2. Aged between 18 and 65 years.

3. Diagnosis of major depressive disorder (MDD) according to DSM-5 criteria.

4. Total score >20 on the Hamilton Depression Rating Scale (HAMD-17).

5. On a stable regimen of psychiatric medications for at least 30 days prior to enrollment.

6. Documented previous trial of at least two first-line antidepressant agents at adequate dose and duration, as assessed by two psychiatrists.

7. Documented previous trial of cognitive behavioral therapy (CBT) or psychotherapy for MDD, sustained for at least 6 weeks.

Exclusion Criteria

1. Pregnant or intending to become pregnant during the study period.

2. 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.

3. Known active seizure disorder, significant head injury with an imaging-verified lesion

4. Unstable medical illness.

5. Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)

6. Inability to reliably attend required screening, treatment, or follow-up appointments.

7. Severe claustrophobia, as identified by the participant, that would prevent completion of MRI procedures.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Nir Lipsman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Nir Lipsman, MD, PhD, FRCSC

Role: CONTACT

Nir.Lipsman@sunnybrook.ca

(416)-480-6954

Anusha Baskaran, PhD

Role: CONTACT

anusha.baskaran@sunnybrook.ca

416-480-6100 ext. 61650

Facility Contacts

Anusha Baskaran, PhD

Role: primary

anusha.baskaran@sunnybrook.ca

416-480-6100 ext. 61650

Other Identifiers

6702

Identifier Type: -

Identifier Source: org_study_id