Medication-refractory Obsessive Compulsive Disorder (OCD)NCT01986296
ExAblate Treatment of Medication Refractory Obsessive Compulsive Disorder
A study testing ExAblate Transcranial MRgFUS System in people with Medication-refractory Obsessive Compulsive Disorder (OCD), run by InSightec at 1 site in South Korea.
Trial summary
The goal of this prospective, non-randomized, single-arm, single site, feasibility study is to develop and collect data to evaluate the safety and initial effectiveness of this treatment using this ExAblate transcranial System in the treatment of Medication-Refractory OCD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Medication-refractory Obsessive Compulsive Disorder (OCD)
- What is being tested?
- ExAblate Transcranial MRgFUS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Dec 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, between 18 and 65 years, inclusive
- Subjects who are able and willing to give consent and able to attend all study visits
- OCD refractory to adequate trials of medication and behavioral therapy by psychiatrist (more than 12 weeks at the maximum tolerated dose with more than two types of serotonin reuptake inhibitors).
- Designated Ablation Targets can be target by the ExAblate device. Designated Ablation Targets must be apparent on MRI such that targeting can be performed with direct visualization.
- Able to communicate sensations during the ExAblate MRgFUS treatment
- Definitive diagnosis of OCD, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorder fourth edition (DSM-IV), with disease duration of more than 3 years, with diagnosed psychosocial dysfunction. (The diagnosis of OCD would be done by psychiatrist)
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- A score on the Y-BOCS of more than 28.
- OCD medication regimen is stable for at least 30 days before enrolment
- Patients with diagnosed psychosocial dysfunction influenced by OCD
Who cannot join
- Patients with unstable cardiac status including:
- Unstable angina pectoris on medication
- Patients with documented myocardial infarction within last 40 days to protocol entry
- Congestive heart failure NYHA Class IV
- Patients exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within a 12 month period:
- Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household).
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- Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use)
- Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct)
- Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).
- Severe hypertension (diastolic BP > 100 on medication)
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium/Magnevist) including advanced kidney disease
- Patients receiving dialysis
- History of abnormal bleeding and/or coagulopathy
- 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 scheduled focused ultrasound procedure
- Active or suspected, acute or chronic uncontrolled infection or known life-threatening systemic disease
- History of intracranial hemorrhage
- Cerebrovascular disease (multiple CVA or CVA within 6 months)
- Evidence for calcifications that might interfere with treatment safety (per CT)
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time.)
- Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema)
- Patients unable to communicate with the investigator and staff
- Presence of any other neurodegenerative disease like Parkinson-plus syndromes suspected on neurological examination. These include:
- Multisystem atrophy
- Progressive supranuclear palsy
- Dementia with Lewy bodies
- Alzheimer's disease
- Subjects diagnosed with idiopathic Parkinson's disease.
- Presence of significant cognitive impairment as determined with a score ≤ 24 on the Mini Mental Status Examination (MMSE)
- History of immunocompromise, including patient who are HIV positive
- Patients with a history of seizures within the past year
- Patients with risk factors for intraoperative or postoperative bleeding:
- Platelet count less than 100,000 per cubic millimeter
- PT > 14
- PTT > 36
- INR > 1.3
- Documented coagulopathy
- Patients receiving medications that are known to induce or contribute to Hemorrhages
- Patients with any types of brain tumors, including metastases
- Any illness that in the investigator's opinion preclude participation in this study
- Pregnancy or lactation
- Patients who have had deep brain stimulation or a prior stereotactic ablation of Designated Ablation Target
- OCD medication regimen is not stable for at least 30 days before enrolment
- Legal incapacity or limited legal capacity
- Subjects with remarkable atrophy and poor healing capacity of the scalp (> 30% of the skull area traversed by the sonication pathway)
- Are participating or have participated in another clinical trial in the last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound Treatment of Medication-Refractory OCD
The goal of this prospective, non-randomized, single-arm, single site, feasibility study is to develop and collect data to evaluate the safety and initial effectiveness of this treatment using this ExAblate transcranial System in the treatment of Medication-Refractory OCD.
Read the detailed description
The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided focused ultrasound thermal ablation of a designated area in the brain of patients suffering from medication-refractory OCD, using the ExAblate transcranial system.
The ExAblate system is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. For OCD Patients: one or more thermal lesion will be created on one of the following targets: Anterior cingulate cortex, Anterior Limb of internal Capsule, Ventral Striatum or Subgenual Cingulate Cortex.
The treatment begins with a series of standard diagnostic MR images to identify the location and shape of tumor to be treated. The ExAblate computer uses the physician's designation of the target volume to plan the best way to cover the target volume with small spots called "sonications". These treatment spots are cylinder shaped. Their size depends on sonication power and duration. During the treatment, a specific MR scan, which can be processed to identify changes in tissue temperature, provides a thermal map of the treatment volume to confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress, and confirm that the ablation is proceeding according to plan, thus closing the therapy loop.
The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing 1000-element phased array transducer) positioned above the subject head. The ExAblate transcranial system also includes means to immobilize the subject head, cool the interface water, and software for CT analysis and phase correction computation.
After informed consent and screening, eligible subjects will proceed to the treatment. All subjects will be followed at Day 1, 7 days, 1 month, 6 months and 1, 2 and 3 years. At follow up visits, patients will be evaluated for general health, neurological changes (including MMSE exam),and efficacy measurements as well as for device/procedure related adverse events that may have occurred during the follow-up period. Six (6) month and 1, 2 and 3 year follow up visits will also include Full Battery Cognitive/Neurological Testing.
- Being tested
- ExAblate Transcranial MRgFUS System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate Transcranial MRgFUS SystemDevice
Treatment with the ExAblate Transcranial MRgFUS System.
| Study group | Role | What they receive |
|---|---|---|
| ExAblate Treatment | Experimental | Not described Receives: Device: ExAblate Transcranial MRgFUS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory OCD
Effectiveness of the ExAblate Transcranial MR-guided Focused Ultrasound (MRgFUS) treatment of medication-refractory OCD will be determined using the Yale-Brown Obsessive-Compulsive Disorder Scale (Y-BOCS), Hamilton Depression Rating Scale (HAM-D), and Hamilton Anxiety Rating Scale (HAM-A) from examinations at baseline and through 6-Months post-ExAblate treatment.
Measured: Participants will be followed from the date of treatment until study completion, up to 36 months
Secondary outcomes (1)
Device or procedure related Adverse Events reported
Safety of the ExAblate transcranial treatment will be determined by an evaluation of the incidence and severity of device and procedure related complications from the first / treatment day visit through the 6-Months post-treatment time point. All Adverse Events (AEs) will be reported and categorized by investigators as definitely, probably, possibly, or unrelated to the device, procedure, or post-surgical changes in neurological status. Alternative treatments resulting from post-surgical changes in neurological status will be reported.
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication-refractory Obsessive Compulsive Disorder (OCD)Studies 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
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Woo Chang, Prof., Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986296
- Sponsor's protocol ID
- OCD001
- Status last verified
- Apr 2020
- First submitted
- 11 Nov 2013
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound Treatment of Medication-Refractory OCD
- ClinicalTrials.gov ID
- NCT01986296
- Acronym / sponsor ID
- OCD001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 18 Nov 2013 (estimated)
- 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.
The goal of this prospective, non-randomized, single-arm, single site, feasibility study is to develop and collect data to evaluate the safety and initial effectiveness of this treatment using this ExAblate transcranial System in the treatment of Medication-Refractory OCD.
Detailed description
The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided focused ultrasound thermal ablation of a designated area in the brain of patients suffering from medication-refractory OCD, using the ExAblate transcranial system.
The ExAblate system is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. For OCD Patients: one or more thermal lesion will be created on one of the following targets: Anterior cingulate cortex, Anterior Limb of internal Capsule, Ventral Striatum or Subgenual Cingulate Cortex.
The treatment begins with a series of standard diagnostic MR images to identify the location and shape of tumor to be treated. The ExAblate computer uses the physician's designation of the target volume to plan the best way to cover the target volume with small spots called "sonications". These treatment spots are cylinder shaped. Their size depends on sonication power and duration. During the treatment, a specific MR scan, which can be processed to identify changes in tissue temperature, provides a thermal map of the treatment volume to confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress, and confirm that the ablation is proceeding according to plan, thus closing the therapy loop.
The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing 1000-element phased array transducer) positioned above the subject head. The ExAblate transcranial system also includes means to immobilize the subject head, cool the interface water, and software for CT analysis and phase correction computation.
After informed consent and screening, eligible subjects will proceed to the treatment. All subjects will be followed at Day 1, 7 days, 1 month, 6 months and 1, 2 and 3 years. At follow up visits, patients will be evaluated for general health, neurological changes (including MMSE exam),and efficacy measurements as well as for device/procedure related adverse events that may have occurred during the follow-up period. Six (6) month and 1, 2 and 3 year follow up visits will also include Full Battery Cognitive/Neurological Testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate Treatment | Experimental | Device: ExAblate Transcranial MRgFUS System |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women, between 18 and 65 years, inclusive
- Subjects who are able and willing to give consent and able to attend all study visits
- OCD refractory to adequate trials of medication and behavioral therapy by psychiatrist (more than 12 weeks at the maximum tolerated dose with more than two types of serotonin reuptake inhibitors).
- Designated Ablation Targets can be target by the ExAblate device. Designated Ablation Targets must be apparent on MRI such that targeting can be performed with direct visualization.
- Able to communicate sensations during the ExAblate MRgFUS treatment
Key exclusion criteria (46 listed)
- Patients with unstable cardiac status including:
- Patients exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within a 12 month period:
- Severe hypertension (diastolic BP > 100 on medication)
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium/Magnevist) including advanced kidney disease
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 Transcranial MRgFUS SystemTreatment with the ExAblate Transcranial MRgFUS System. | Device | ExAblate Treatment |
Primary outcome
Effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory OCD
Time frame: Participants will be followed from the date of treatment until study completion, up to 36 months
Effectiveness of the ExAblate Transcranial MR-guided Focused Ultrasound (MRgFUS) treatment of medication-refractory OCD will be determined using the Yale-Brown Obsessive-Compulsive Disorder Scale (Y-BOCS), Hamilton Depression Rating Scale (HAM-D), and Hamilton Anxiety Rating Scale (HAM-A) from examinations at baseline and through 6-Months post-ExAblate treatment.
1 secondary outcome
Device or procedure related Adverse Events reported
Time frame: 36 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Sponsor websiteLink provided by the sponsor.
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.
Jin Woo Chang, Prof. principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate Transcranial MRgFUS System in people with Medication-refractory Obsessive Compulsive Disorder (OCD), run by InSightec at 1 site in South Korea.
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 9 inclusion and 46 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: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory OCD (time frame: Participants will be followed from the date of treatment until study completion, up to 36 months). 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 13 Apr 2020; AzTrials last refreshed its copy on 2 Nov 2026.