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

MR-Guided Functional Ultrasound-Neurosurgery

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.

Study Overview

• Status: Unknown
• Conditions: Functional Brain Disorders /Neuropathic Pain
• Intervention / Treatment: Device: ExAblate 4000 focused ultrasound brain intervention

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, CH-8032
    • Recruiting
    • MR-Center, University Children's Hospital
    • Contact: Ernst - Martin, MD; Phone Number: 7437 +41 44 266 7111; Email: ernst.martin@kispi.uzh.ch
    • Contact: Ronald - Bauer, MD; Phone Number: 3054 +41 71 494 1111; Email: ronald.bauer@kssg.ch
    • Principal Investigator: Ernst - Martin, MD
    • Sub-Investigator: Beat - Werner, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Trancranial MRg Focused Ultrasound for Neuropatic Pain	Device: ExAblate 4000 focused ultrasound brain intervention; Non-invasive brain intervention using MR-guided focused ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Investigators: Principal Investigator: Ronald - Bauer, MD, Neurosurgery, Kantonsspital St. Gallen, Switzerland; Principal Investigator: Gunther - Landmann, MD, Center for Pain Medicine, Nottwil, Switzerland

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: April 27, 2012
• First Submitted That Met QC Criteria: October 2, 2012
• First Posted (Estimate): October 3, 2012

Study Record Updates

• Last Update Posted (Estimate): October 3, 2012
• Last Update Submitted That Met QC Criteria: October 2, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: movement disorders; neuropathic pain; focused ultrasound; FUS; functional brain disorders
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Brain Diseases
• Other Study ID Numbers: E-04/2008