ExAblate Treatment of Medication Refractory Obsessive Compulsive Disorder

NCT01986296 | Completed DMC

• 1 other identifier: OCD001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Medication-refractory Obsessive Compulsive Disorder (OCD)

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  36 month

Study Arms (1)

ExAblate Treatment

EXPERIMENTAL

Device: ExAblate Transcranial MRgFUS System

Interventions

ExAblate Transcranial MRgFUS System DEVICE

Treatment with the ExAblate Transcranial MRgFUS System.

ExAblate Treatment

Eligibility Criteria

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

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• InSightec: lead

Study Sites (1)

Yonsei University Medical Center

Seoul, 120-752, South Korea

Location

Related Links

• Sponsor website

Study Officials

• Jin Woo Chang, Prof.

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 18, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 13, 2020

Record last verified: 2020-04

Locations

KR (1)