Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression

Sunnybrook Health Sciences Centre

Status: Enrolling

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

Treatments: Device: Next Generation Dome Helmet (NGDH)

Study type: Interventional

Funder types: Other

Identifiers

NCT07094789

6702

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Focused Ultrasound Neuromodulation

Experimental group

Description:

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.

Treatment:

Device: Next Generation Dome Helmet (NGDH)