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

Phase 1

• Conditions: Functional Brain Disorders /Neuropathic Pain
• Interventions: Device: ExAblate 4000 focused ultrasound brain intervention

• Registration Number: NCT01699477
• Lead Sponsor: University Children's Hospital, Zurich

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 available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2012-04-27
• Status Verified: 2012-10
• Study First Submitted QC: 2012-10-02
• Last Update Submitted: 2012-10-02
• Study First Posted: 2012-10-03
• Last Update Posted: 2012-10-03
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trancranial MRg Focused Ultrasound for Neuropatic Pain	ExAblate 4000 focused ultrasound brain intervention	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

MR-Center, University Children's Hospital; 🇨🇭 Zurich, Switzerland