Safety Study Using Transcranial MR Guided Focused Ultraso... | NCT01699477

Studies
Safety Study Using Transcranial MR Guided Focused Ultrasound in the Treatment of Neuropathic Pain

NCT01699477

Sponsor

University Children's Hospital, Zurich

Status

Unknown status

Last Update Posted

Oct 3, 2012Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Functional Brain Disorders /Neuropathic Pain

Interventions

ExAblate 4000 focused ultrasound brain intervention

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Apr 27, 2012

First Submission Date that Met QC Criteria

Oct 2, 2012

First Posted Date

Oct 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2012

Last Update Posted Date

Oct 3, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to asses the efficacy and the clinical safety of the transcranial magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec Ltd. for functional neurosurgery. The treatments to be conducted in this study are non-invasive, i.e. without opening the skull, and will create micro-thalamotomies in specific target areas such as thalamus, subthalamus and pallidum. The data obtained in this study will be used to evaluate the basic safety aspects of this new treatment technology and will serve as a basis for the clinical introduction of MR-guided ultrasound-neurosurgery.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trancranial MRg Focused Ultrasound for Neuropatic Pain	Other		Device: ExAblate 4000 focused ultrasound brain intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ExAblate 4000 focused ultrasound brain intervention	Device	Non-invasive brain intervention using MR-guided focused ultrasound	Trancranial MRg Focused Ultrasound for Neuropatic Pain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Precision of lesioning	Comparison of size and location of sonicaion lesions on MRI with planning coordinates.	3 months
Safety measurements	Number of Participants with Adverse Events as a Measure of Safety and Tolerability.	6 months
Lesion characteristics	Size of lesions as a function of applied energy/temperature.	3 months

Secondary Outcomes

Measure	Description	Time Frame
Clinical Efficacy	Pain Scores on the Visual Analog Scale following intervention and at follow-up.	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female patients 18 years and older
Clinical indication for a medial thalamotomy
Stereotactic targets within thalamus, subthalamus and pallidum
All targets supposedly accessible by TcMRgFUS
Physically and mentally able to understand the risks of participating in this study and to give written informed consent based on the patient information provided
Sufficient proficiency in one of the languages German, French, Italian or English to al-low for verbal communication during all phases of the study
Physically and mentally able to communicate the personal condition and all feelings during the TcMRgFUS treatment
Physically and mentally able to undergo the TcMRgFUS treatment

Exclusion Criteria:

Anomalies of brain anatomy, especially in or around thalamus or pallidum that will in-fluence the atlas-based navigation
Existing lesions in close proximity (<5mm) to planned ablation targets
Extended anomalies of scalp such as scars, inflammations, etc.
Clips or other implanted objects close to (< 3cm) target
Non-MRI-compatible cardiac pacemaker
Previous hemorrhages in the brain
Uncontrolled arterial hypertension
Any coagulopathy or patient under anticoagulant therapy
Sensitivity to MRI contrast agents
Contraindications to MRI such as non-MRI-compatible implanted devices
Large patients not fitting comfortably into the MRI unit (generally >110kg)
Difficulty to lie supine and still for up to 4 hours in the MRI unit or claustrophobia
Other known life-threatening systemic disease
Patients currently participating or participated in another clinical trial in the last 30 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ernst - Martin, MD	Contact	+41 44 266 7111	7437	ernst.martin@kispi.uzh.ch
Beat - Werner, MSc	Contact	+41 44 266 7111	8123	beat.werner@kispi.uzh.ch

Overall Officials

Name	Affiliation	Role
Ernst - Martin, MD	University Children's Hospital, Zurich	Principal Investigator
Ronald - Bauer, MD	Neurosurgery, Kantonsspital St. Gallen, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MR-Center, University Children's Hospital	Recruiting	Zurich	Canton of Zurich	CH-8032	Switzerland

Type	Date	Date Unknown
Release	Sep 12, 2013
Reset	Nov 14, 2013
Release	Oct 7, 2014
Reset	Oct 9, 2014
Release	Jan 22, 2015
Reset	Feb 6, 2015
Release	Mar 16, 2015
Reset	Mar 21, 2015
Release	Aug 24, 2015
Reset	Sep 23, 2015
Release	Jun 3, 2016
Reset	Jul 13, 2016
Release	Oct 28, 2016
Reset	Dec 20, 2016
Release	Nov 13, 2024
Reset	Jan 2, 2025
Release	Apr 27, 2026
Reset	May 18, 2026

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 12, 2013			Nov 14, 2013
Oct 7, 2014

ID	Term
D009437	Neuralgia
D009069	Movement Disorders

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain