Safety Study Using Transcranial MR Guided Focused Ultrasound in the Treatment of Neuropathic Pain (FUS-CLT)
This study is currently recruiting participants.
Verified October 2012 by University Children's Hospital, Zurich
Sponsor:
University Children's Hospital, Zurich
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
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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:
- 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
Contacts and Locations
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:
|
Brain Diseases Neuralgia Central Nervous System Diseases Nervous System Diseases Pain |
Neurologic Manifestations Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013