Recruiting

Magnetic Resonance-guided Focused Ultrasound

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT07094789

Conditions

Treatment-Resistant Depression

Treatment-resistant Depression (TRD)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Next Generation Dome Helmet (NGDH)

Study Details

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)

Study ID

NCT07094789

Start date

Jul 11, 2025

Status verified date

Jul, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients with Treatment-Resistant Depression [ 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. ]

Central Contacts and Locations

Central contacts

Nir Lipsman, MD, PhD, FRCSC

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

Anusha Baskaran, PhD

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

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Anusha Baskaran, PhD

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

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Aug 11, 2025

Last verified

Jul, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2025-08-11.