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Safety Study Using Transcranial MR Guided Focused Ultrasound in the Treatment of Neuropathic Pain (FUS-CLT)

Primary Purpose

Functional Brain Disorders /Neuropathic Pain

Status
Unknown status
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
ExAblate 4000 focused ultrasound brain intervention
Sponsored by
University Children's Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Functional Brain Disorders /Neuropathic Pain focused on measuring FUS, focused ultrasound, functional brain disorders, neuropathic pain, movement disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male and female patients 18 years and older
  2. Clinical indication for a medial thalamotomy
  3. Stereotactic targets within thalamus, subthalamus and pallidum
  4. All targets supposedly accessible by TcMRgFUS
  5. 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
  6. Sufficient proficiency in one of the languages German, French, Italian or English to al-low for verbal communication during all phases of the study
  7. Physically and mentally able to communicate the personal condition and all feelings during the TcMRgFUS treatment
  8. Physically and mentally able to undergo the TcMRgFUS treatment

Exclusion Criteria:

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

Sites / Locations

  • MR-Center, University Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Trancranial MRg Focused Ultrasound for Neuropatic Pain

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical Efficacy
Pain Scores on the Visual Analog Scale following intervention and at follow-up.

Full Information

First Posted
April 27, 2012
Last Updated
October 2, 2012
Sponsor
University Children's Hospital, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01699477
Brief Title
Safety Study Using Transcranial MR Guided Focused Ultrasound in the Treatment of Neuropathic Pain
Acronym
FUS-CLT
Official Title
MR-Guided Functional Ultrasound-Neurosurgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital, Zurich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Brain Disorders /Neuropathic Pain
Keywords
FUS, focused ultrasound, functional brain disorders, neuropathic pain, movement disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trancranial MRg Focused Ultrasound for Neuropatic Pain
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
ExAblate 4000 focused ultrasound brain intervention
Intervention Description
Non-invasive brain intervention using MR-guided focused ultrasound
Primary Outcome Measure Information:
Title
Precision of lesioning
Description
Comparison of size and location of sonicaion lesions on MRI with planning coordinates.
Time Frame
3 months
Title
Safety measurements
Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Time Frame
6 months
Title
Lesion characteristics
Description
Size of lesions as a function of applied energy/temperature.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Clinical Efficacy
Description
Pain Scores on the Visual Analog Scale following intervention and at follow-up.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ernst - Martin, MD
Phone
+41 44 266 7111
Ext
7437
Email
ernst.martin@kispi.uzh.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Beat - Werner, MSc
Phone
+41 44 266 7111
Ext
8123
Email
beat.werner@kispi.uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernst - Martin, MD
Organizational Affiliation
University Children's Hospital, Zurich
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald - Bauer, MD
Organizational Affiliation
Neurosurgery, Kantonsspital St. Gallen, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gunther - Landmann, MD
Organizational Affiliation
Center for Pain Medicine, Nottwil, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
MR-Center, University Children's Hospital
City
Zurich
ZIP/Postal Code
CH-8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernst - Martin, MD
Phone
+41 44 266 7111
Ext
7437
Email
ernst.martin@kispi.uzh.ch
First Name & Middle Initial & Last Name & Degree
Ronald - Bauer, MD
Phone
+41 71 494 1111
Ext
3054
Email
ronald.bauer@kssg.ch
First Name & Middle Initial & Last Name & Degree
Ernst - Martin, MD
First Name & Middle Initial & Last Name & Degree
Beat - Werner, MSc

12. IPD Sharing Statement

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

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