Safety Study Using Transcranial MR Guided Focused Ultrasound in the Treatment of Neuropathic Pain
NCT ID: NCT01699477
Last Updated: 2012-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2008-08-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Trancranial MRg Focused Ultrasound for Neuropatic Pain
ExAblate 4000 focused ultrasound brain intervention
Non-invasive brain intervention using MR-guided focused ultrasound
Interventions
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ExAblate 4000 focused ultrasound brain intervention
Non-invasive brain intervention using MR-guided focused ultrasound
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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University Children's Hospital, Zurich
OTHER
Responsible Party
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Principal Investigators
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Ernst - Martin, MD
Role: PRINCIPAL_INVESTIGATOR
University Children's Hospital, Zurich
Ronald - Bauer, MD
Role: PRINCIPAL_INVESTIGATOR
Neurosurgery, Kantonsspital St. Gallen, Switzerland
Gunther - Landmann, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Pain Medicine, Nottwil, Switzerland
Locations
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MR-Center, University Children's Hospital
Zurich, Canton of Zurich, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Ernst - Martin, MD
Role: primary
Ronald - Bauer, MD
Role: backup
Other Identifiers
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E-04/2008
Identifier Type: -
Identifier Source: org_study_id