Echo-Focusing in Patients With Treatment-Resistant Neurologic and Psychiatric Indications (EF001)

NCT05089786 | Withdrawn DMC

• 1 other identifier: EF001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluate the safety and effectiveness of Echo-Focusing using Exablate Neuro as a tool for treating patients with treatment-refractory neurologic and psychiatric disorders.

Conditions

Essential Tremor; Neurology

Outcome Measures

Primary Outcomes (2)

• Serious Adverse Events

  Safety will be assessed by evaluating the incidence and severity of device and procedure related adverse events

  Time of Exablate transcranial procedure

• Change in Quality of Life per the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)

  Clinical efficacy will be assessed by evaluating change in quality of life per the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF). This 16-item self-report rating inventory measures the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning (scale 1 to 5). A higher total score correlates with greater satisfaction. The survey will be collected before and after treatment at day 1 and months 1, 3, 6, and 12 to determine any effect and its change over time.

  12 months

Study Arms (1)

Exablate Neuro System Treatment

EXPERIMENTAL

MR-Guided Focused Ultrasound with Echo-Focusing will be used to ablate a target area selected by the physician.

Device: Exablate Neuro Type 1.0 System with Echo Focusing

Interventions

Exablate Neuro Type 1.0 System with Echo Focusing DEVICE

MR-Guided Focused Ultrasound

Also known as: Focused Ultrasound, MRgFUS, FUS

Exablate Neuro System Treatment

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥ 20 and ≤ 80 years of age.
• Patients who are able and willing to give consent and physically and practically able to attend study visits, as determined by both study psychiatrist and the surgeon.
• DSM-V diagnosis of major depressive disorder (MDD), or bipolar disorder with predominant depressive symptoms.
• At least 5-year illness history of the primary disorder and at least 6 months since the onset of the first episode of major depression.
• A minimum score of 20 on the Hamilton Depression Rating Scale (HAMD) when depressed (patients with bipolar disorder may be rapid cycling, but must have at least 2 weeks of major depression at the time the HAMD is conducted).
• Medication-refractoriness as determined by an adequate dose and duration of standard psychiatric treatments (including psychotherapy and/or pharmacology) as determined by a psychiatrist associated with the study. Including specifically:
• Failed to respond or tolerate adequate trials of three or more medications accepted as first line therapies in the treatment of depression.
• Failed to respond or tolerate augmentation with or combination of at least 2 medications known to be first line treatments for depression.
• An adequate trial of Cognitive Behavioural Therapy (CBT) or other evidence-supported psychotherapy, delivered by a therapist experienced in treating depression.
• Able to communicate sensations during the Exablate MRgFUS treatment.
• A consistent dose of any and all medications in the 30 days prior to study entry.
• Women of childbearing potential must agree to use a contraception method throughout the study.
• Men and women ≥20 and ≤80 years of age.
• Patients who are able and willing to give consent and physically and practically able to attend study visits, as determined by both study psychiatrist and the surgeon.
• DSM-V diagnosis of Obsessive-Compulsive Disorder (OCD), at least 5-year illness history with a minimum score of 28 on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS).

You may not qualify if:

• Patients with unstable cardiac status \[e.g., unstable angina pectoris on medication, patients with documented myocardial infarction within six months, congestive heart failure requiring medication (other than diuretics), patients on anti-arrhythmic drugs, severe hypertension (defined as systolic blood pressure \> 150 mm Hg or diastolic blood pressure \> 100 mm Hg while on medication)\].
• Patients with standard contraindications for MRI imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
• Severely impaired renal function (estimated glomerular filtration rate \< 30 ml/min/1.73 m2) or receiving dialysis.
• Laboratory biochemical evidence of abnormal bleeding and/or coagulopathy, including risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter or abnormal INR).
• Cerebrovascular disease (e.g., CVA within 6 months) or history of intracranial hemorrhage.
• Untreated, uncontrolled sleep apnea.
• Receiving anticoagulant (e.g., warfarin) or antiplatelet (e.g., aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g., Avastin) within one month of focused ultrasound procedure.
• Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment.
• Patients unable to communicate with the investigator and staff.
• Presence of significant cognitive impairment.
• Presence of psychosis on clinical evaluation.
• Patients with brain tumors already known or revealed on pretreatment MRI.
• Currently pregnant (as determined by history and serum HCG) or lactating.
• Patients who have right-to-left, bidirectional, or transient right-to-left cardiac shunts.
• Patients with relative contraindications to DEFINITY ultrasound contrast agent including subjects with a family or personal history of QT prolongation or taking concomitant medications known to cause QTc prolongation (QT prolongation observed on screening ECG (QTc \> 450 for men and \>470 for women).

Sponsors & Collaborators

• InSightec: lead
• Health Canada: collaborator

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-arm, non-randomized, feasibility trial with no control group seeks to evaluate the safety and efficacy of using the Exablate 4000 Type 1 or 1.1 System with Echo-focusing in patients with Major Depressive Disorder (MDD), Obsessive Compulsive Disorder (OCD), Essential Tremor (ET), Post Traumatic Stress Disorder (PTSD), anorexia nervosa (AN).

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 22, 2021
• Study Start: December 31, 2022
• Primary Completion: December 31, 2023
• Study Completion: February 28, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04