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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by University Children's Hospital, Zurich.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT01699477
First received: April 27, 2012
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Functional Brain Disorders /Neuropathic Pain
Device: ExAblate 4000 focused ultrasound brain intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: MR-Guided Functional Ultrasound-Neurosurgery

Resource links provided by NLM:


Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:
  • Precision of lesioning [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Comparison of size and location of sonicaion lesions on MRI with planning coordinates.

  • Safety measurements [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

  • Lesion characteristics [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Size of lesions as a function of applied energy/temperature.


Secondary Outcome Measures:
  • Clinical Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Pain Scores on the Visual Analog Scale following intervention and at follow-up.


Estimated Enrollment: 30
Study Start Date: August 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Trancranial MRg Focused Ultrasound for Neuropatic Pain Device: ExAblate 4000 focused ultrasound brain intervention
Non-invasive brain intervention using MR-guided focused ultrasound

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699477

Contacts
Contact: Ernst - Martin, MD +41 44 266 7111 ext 7437 ernst.martin@kispi.uzh.ch
Contact: Beat - Werner, MSc +41 44 266 7111 ext 8123 beat.werner@kispi.uzh.ch

Locations
Switzerland
MR-Center, University Children's Hospital Recruiting
Zurich, Switzerland, CH-8032
Contact: Ernst - Martin, MD    +41 44 266 7111 ext 7437    ernst.martin@kispi.uzh.ch   
Contact: Ronald - Bauer, MD    +41 71 494 1111 ext 3054    ronald.bauer@kssg.ch   
Principal Investigator: Ernst - Martin, MD         
Sub-Investigator: Beat - Werner, MSc         
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
Principal Investigator: Ernst - Martin, MD University Children's Hospital Zurich, Switzerland
Principal Investigator: Ronald - Bauer, MD Neurosurgery, Kantonsspital St. Gallen, Switzerland
Principal Investigator: Gunther - Landmann, MD Center for Pain Medicine, Nottwil, Switzerland
  More Information

No publications provided

Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT01699477     History of Changes
Other Study ID Numbers: E-04/2008
Study First Received: April 27, 2012
Last Updated: October 2, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University Children's Hospital, Zurich:
FUS
focused ultrasound
functional brain disorders
neuropathic pain
movement disorders

Additional relevant MeSH terms:
Neuralgia
Brain Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Central Nervous System Diseases

ClinicalTrials.gov processed this record on October 16, 2014