Functional Brain Disorders /Neuropathic PainPhase 1FUS-CLTNCT01699477
Safety Study Using Transcranial MR Guided Focused Ultrasound in the Treatment of Neuropathic Pain
A Phase 1 study testing ExAblate 4000 focused ultrasound brain intervention in people with Functional Brain Disorders /Neuropathic Pain, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Brain Disorders /Neuropathic Pain
- What is being tested?
- ExAblate 4000 focused ultrasound brain intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2008to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
MR-Center, University Children's Hospital
Zurich, Canton of Zurich, CH-8032
Ernst - Martin, MD, +41 44 266 7111 ext. 7437, ernst.martin@kispi.uzh.ch
Ronald - Bauer, MD, +41 71 494 1111 ext. 3054, ronald.bauer@kssg.ch
About this study
Official title: 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.
- Being tested
- ExAblate 4000 focused ultrasound brain intervention
- Keywords
- FUS, focused ultrasound, functional brain disorders, neuropathic pain, movement disorders
- Medical subject headings
- Neuralgia, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate 4000 focused ultrasound brain interventionDevice
Non-invasive brain intervention using MR-guided focused ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Trancranial MRg Focused Ultrasound for Neuropatic Pain | Other | Not described Receives: Device: ExAblate 4000 focused ultrasound brain intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision of lesioning
Comparison of size and location of sonicaion lesions on MRI with planning coordinates.
Measured: 3 months
Safety measurements
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Measured: 6 months
Lesion characteristics
Size of lesions as a function of applied energy/temperature.
Measured: 3 months
Secondary outcomes (1)
Clinical Efficacy
Pain Scores on the Visual Analog Scale following intervention and at follow-up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startAug 2008
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Brain Disorders /Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ernst - Martin, MD, Principal investigator, University Children's Hospital, ZurichRonald - Bauer, MD, Principal investigator, Neurosurgery, Kantonsspital St. Gallen, SwitzerlandGunther - Landmann, MD, Principal investigator, Center for Pain Medicine, Nottwil, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699477
- Sponsor's protocol ID
- E-04/2008
- Acronym
- FUS-CLT
- Status last verified
- Oct 2012
- First submitted
- 27 Apr 2012
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-Guided Functional Ultrasound-Neurosurgery
- ClinicalTrials.gov ID
- NCT01699477
- Acronym / sponsor ID
- FUS-CLT / E-04/2008
- Keywords
- FUS, focused ultrasound, functional brain disorders, neuropathic pain, movement disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trancranial MRg Focused Ultrasound for Neuropatic Pain | Other | Device: ExAblate 4000 focused ultrasound brain intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExAblate 4000 focused ultrasound brain interventionNon-invasive brain intervention using MR-guided focused ultrasound | Device | Trancranial MRg Focused Ultrasound for Neuropatic Pain |
Primary outcome
Precision of lesioning
Time frame: 3 months
Comparison of size and location of sonicaion lesions on MRI with planning coordinates.
Safety measurements
Time frame: 6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Lesion characteristics
Time frame: 3 months
Size of lesions as a function of applied energy/temperature.
1 secondary outcome
Clinical Efficacy
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernst - Martin, MD principal investigator
University Children's Hospital, Zurich
Ronald - Bauer, MD principal investigator
Neurosurgery, Kantonsspital St. Gallen, Switzerland
Gunther - Landmann, MD principal investigator
Center for Pain Medicine, Nottwil, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ExAblate 4000 focused ultrasound brain intervention in people with Functional Brain Disorders /Neuropathic Pain, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ernst - Martin, MD (+41 44 266 7111 ext. 7437, ernst.martin@kispi.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precision of lesioning (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2012.