Essential TremorNCT05089786
Echo-Focusing in Patients With Treatment-Resistant Neurologic and Psychiatric Indications (EF001)
A study testing Exablate Neuro Type 1.0 System with Echo Focusing in people with Essential Tremor and Neurology, run by InSightec.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Essential Tremor, Neurology
- What is being tested?
- Exablate Neuro Type 1.0 System with Echo Focusing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2022to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 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 adequate trial of three or more medications accepted as first line therapies in the treatment of OCD.
- Attempted augmentation, if tolerated, by at least 2 medications known to be first line treatments for OCD.
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- An adequate trial of CBT, delivered by a therapist experienced in treating OCD.
- A consistent dose of all medications in the 30 days prior to study entry.
- Able to communicate sensations during the Exablate MRgFUS treatment.
- Women of childbearing potential must agree to use a contraception method throughout the study.
- Inclusion Criteria for Post Traumatic Stress Disorder (PTSD):
- 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.
- Diagnosis of Post-Traumatic Stress Disorder and Major Depressive Disorder, as defined by the Diagnostic and Statistical Manual fifth edition (DSM V).
- Severe PTSD symptoms, as measured by Clinician Administered PTSD scale (CAPS) scores ≥ 50.
- Treatment Resistance as defined by the persistence of clinical symptoms despite adequate treatment with four modalities, including a) selective serotonin reuptake inhibitors, b) cognitive behavioral therapy, c) other classes of medications and/or psychotherapy.
- DSM-V diagnosis of major depressive disorder with at least 5 years illness history .
- A minimum score of 20 on the Hamilton Depression Rating Scale (HAMD).
- A pattern of chronic stable PTSD lasting at least 1 year.
- 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 anorexia nervosa, restricting or binge-purging subtype.
- Chronicity of treatment resistance shown by some or all of:
- A pattern of 3 years' duration of relentless unresponsiveness to ≥ 2 voluntary hospital admissions, characterized by failure to complete treatment or immediate weight relapse after treatment
- A pattern of increasing medical instability, accompanied by refusal to participate in or a pattern of poor response to intensive expert treatment and increasing medical acuity, lasting at least 2 years, and including at least 2 episodes of involuntary feeding.
- A pattern of chronic stable anorexia nervosa that has lasted at least 10 years.
- DSM-V diagnosis of major depressive disorder OR obsessive-compulsive disorder with at least 5 years illness history:
- If MDD diagnosis, HAMD > 20; if OCD diagnosis, YBOCS ≥ 28.
- Treatment refractory to either MDD or OCD, with documented non-response to three primary medication trials, 2 augmentation trials, and at least one completed course of CBT.
- Potassium levels within normal laboratory range.
- 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 neurologist and the surgeon.
- A confirmed diagnosis of Essential Tremor by a neurologist.
- Refractory to at least two trials of medication therapy, including at least one first-line agent (propranolol or primidone).
- 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.
Who cannot join
- 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.
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- 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).
- Currently admitted as an inpatient to a medical facility.
About this study
Official title: Assessment of Safety and Feasibility of Exablate Neuro System to Perform Echo-Focusing Echo Imaging in Patients With Treatment-Resistant Neurologic and Psychiatric Indications
Evaluate the safety and effectiveness of Echo-Focusing using Exablate Neuro as a tool for treating patients with treatment-refractory neurologic and psychiatric disorders.
Read the detailed description
The objective of the proposed study is to evaluate the safety and effectiveness of Echo-Focusing using Exablate Neuro as a tool for treating patients with treatment-refractory neurologic and psychiatric disorders. Safety will be determined by an evaluation of the incidence and severity of procedure-related complications from the treatment day visit through the 12-month post-treatment time point, although events that are not procedure or device related will be also captured and recorded. Clinical efficacy will be determined using standard clinical metrics, appropriate for the patient's condition.
The hypotheses tested include:
- Exablate ablation with Echo-Focusing can be safely performed in patients suffering from treatment-resistant psychiatric illness and essential tremor.
- Echo-Focusing will allow for more efficient (faster) treatments, which require less energy (measured in Joules), as compared to published data from Exablate thalamotomy99 and Exablate-capsulotomy100 performed without Echo-Focusing.
- Lesion appearances following Exablate ablation with Echo-Focusing will be similar in radiographic appearance to those created without Echo-Focusing.
- Patients who undergo Exablate ablation with Echo-Focusing will demonstrate similar rates of clinical improvement from those seen after non-Echo-Focusing ablation.
- Conditions
- Essential Tremor, Neurology
- Being tested
- Exablate Neuro Type 1.0 System with Echo Focusing
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exablate Neuro Type 1.0 System with Echo FocusingDevice
Also called Focused Ultrasound, MRgFUS, FUS
MR-Guided Focused Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Exablate Neuro System Treatment | Experimental | MR-Guided Focused Ultrasound with Echo-Focusing will be used to ablate a target area selected by the physician. Receives: Device: Exablate Neuro Type 1.0 System with Echo Focusing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
Safety will be assessed by evaluating the incidence and severity of device and procedure related adverse events
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start31 Dec 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion28 Feb 2025 (estimated)
Why it stopped: Administrative decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by InSightecThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Health Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089786
- Sponsor's protocol ID
- EF001
- Status last verified
- Apr 2026
- First submitted
- 22 Sep 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Feasibility of Exablate Neuro System to Perform Echo-Focusing Echo Imaging in Patients With Treatment-Resistant Neurologic and Psychiatric Indications
- ClinicalTrials.gov ID
- NCT05089786
- Acronym / sponsor ID
- EF001
- Conditions
- Essential Tremor, Neurology
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Collaborators
- Health Canada
- Study start
- 31 Dec 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and effectiveness of Echo-Focusing using Exablate Neuro as a tool for treating patients with treatment-refractory neurologic and psychiatric disorders.
Detailed description
The objective of the proposed study is to evaluate the safety and effectiveness of Echo-Focusing using Exablate Neuro as a tool for treating patients with treatment-refractory neurologic and psychiatric disorders. Safety will be determined by an evaluation of the incidence and severity of procedure-related complications from the treatment day visit through the 12-month post-treatment time point, although events that are not procedure or device related will be also captured and recorded. Clinical efficacy will be determined using standard clinical metrics, appropriate for the patient's condition.
The hypotheses tested include:
- Exablate ablation with Echo-Focusing can be safely performed in patients suffering from treatment-resistant psychiatric illness and essential tremor.
- Echo-Focusing will allow for more efficient (faster) treatments, which require less energy (measured in Joules), as compared to published data from Exablate thalamotomy99 and Exablate-capsulotomy100 performed without Echo-Focusing.
- Lesion appearances following Exablate ablation with Echo-Focusing will be similar in radiographic appearance to those created without Echo-Focusing.
- Patients who undergo Exablate ablation with Echo-Focusing will demonstrate similar rates of clinical improvement from those seen after non-Echo-Focusing ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Exablate Neuro System Treatment | Experimental | Device: Exablate Neuro Type 1.0 System with Echo FocusingMR-Guided Focused Ultrasound with Echo-Focusing will be used to ablate a target area selected by the physician. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (43 listed)
- 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).
- 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:
- An adequate trial of CBT, delivered by a therapist experienced in treating OCD.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exablate Neuro Type 1.0 System with Echo FocusingAlso: Focused Ultrasound, MRgFUS, FUSMR-Guided Focused Ultrasound | Device | Exablate Neuro System Treatment |
Primary outcome
Serious Adverse Events
Time frame: Time of Exablate transcranial procedure
Safety will be assessed by evaluating the incidence and severity of device and procedure related adverse events
Change in Quality of Life per the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)
Time frame: 12 months
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exablate Neuro Type 1.0 System with Echo Focusing in people with Essential Tremor and Neurology, run by InSightec.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 43 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: Time of Exablate transcranial procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.