Multiple SclerosisNCT02614989
MRI Guided Focused Ultrasound for Tremor in Multiple Sclerosis
A study testing MRI guided focused ultrasound thalamotomy in people with Multiple Sclerosis, run by Rambam Health Care Campus.
Trial summary
This project goal is to explore the option of (MRgFUS) as a treatment for tremor in MS patients with disabling refractory tremor. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MRI guided focused ultrasound thalamotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2018
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, age 18 years and older
- Patients who are able and willing to give informed consent and able to attend all study visits
- Patients with a diagnosis of Multiple sclerosis (MS) as confirmed from clinical history and examination by a neurologist.
- The patient must have disabling tremor from MS as indicated by a score of at least 2 on the Tremor Rating Scale (TRS) baseline global assessments by the examiner and the patient. Or Disabling is defined as significant impairment of the normal functions of daily life as indicated by a score of at least 5 on the Clinical Global Impression (CGI)-Severity scale.or ETRS
- The MS patient must have disabling and medically refractory unilateral or bilateral upper extremity tremor. Patients with associated ipsilateral lower extremity tremor are not excluded.
- The patient must have a history of an unsatisfactory response to medical management. Any patient will need to have tried and failed at least one drug. Alternatively, a patient may also qualify if tremor-suppressing medications are contraindicated due to a coexisting medical condition or drug allergy.
- Patients should be on a stable dose of medications for 30 days prior to study entry
Who cannot join
- Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Significant claustrophobia
- Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
- Subjects with unstable cardiac status
- Severe hypertension
- Current medical condition resulting in abnormal bleeding and/or coagulopathy
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- Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within two weeks of focused ultrasound procedure or drugs known to increase risk or hemorrhage
- History of intracranial hemorrhage
- History of multiple strokes, or a stroke within past 6 months
- Subjects with a history of seizures within the past year
- Subjects with brain tumors
- Are participating or have participated in another clinical trial in the last 30 days
- More than mild non-tremor cerebellar dysfunction (ataxia, dysmetria, dysdiadokokinesia).
- Cognitive dysfunction as evidenced by a score of less than ??? on the ???
Trial locations and contacts
No sites are listed yet.
About this study
This project goal is to explore the option of (MRgFUS) as a treatment for tremor in MS patients with disabling refractory tremor.
Read the detailed description
This study is designed as a prospective, single site, single arm, nonrandomized study. Assessments will be made before and after MRgFUS for clinical symptom relief, quality of life (QoL) improvements, and safety of MRgFUS in the treatment of multiple sclerosis patients with severe medication refractory tremor.
This study will be performed on the 3T MR scanners. The ExAblate system is a medical device that involves a focused ultrasound system and an MRI scanner. During MRgFUS a pulse of focused ultrasound energy, or sonication,are delivered to the targeted tissue. In this particular study the targeted tissue is a unilateral thermal lesion created in the ventralis intermedius nucleus of the thalamus.
The treatment begins with a series of standard diagnostic MR images to identify the location and shape of tumor to be treated. The computer uses the physician's designation of the target volume to plan the best way to cover the target volume with small spots called "sonications". These treatment spots are cylinder shaped. Their size depends on sonication power and duration. During the treatment, a specific MR scan, which can be processed to identify changes in tissue temperature, provides a thermal map of the treatment volume to confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress, and confirm that the ablation is proceeding according to plan, thus closing the therapy loop.
MRgFUS uses a transcranial operated helmet-shaped transducer positioned above the subject head. The transcranial system includes means to immobilize the subject head, cool the interface water, and software for CT analysis and phase correction computation.
MRgFUS transcranial system to relieve tremor in multiple sclerosis patients is being investigated in this study.
- Conditions
- Multiple Sclerosis
- Being tested
- MRI guided focused ultrasound thalamotomy
- Keywords
- Tremor, Thalamotomy
- Medical subject headings
- Multiple Sclerosis, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI guided focused ultrasound thalamotomyProcedure or surgery
MRI guided focused ultrasound thalamotomy
| Study group | Role | What they receive |
|---|---|---|
| MRI guided Focused Ultrasound treatment | Experimental | MRI guided focused ultrasound thalamotomy
Patients will undergo unilateral thalmotomy using MRI guided Focused Ultrasound intervention for the treatment of the tremor Receives: Procedure: MRI guided focused ultrasound thalamotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device or procedure related adverse events reported
Safety of the MRI guided focused Ultrasound treatment will be determined by an evaluation of the incidence and severity of device and procedure related complications from the first / treatment day visit through the 3-Months post-treatment time point. All AEs will be reported.
Measured: 3 months
Secondary outcomes (1)
Tremor rating scale
Tremor Rating Scale
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614989
- Sponsor's protocol ID
- 0556-15-RMB
- Status last verified
- Nov 2015
- First submitted
- 23 Nov 2015
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Guided Focused Ultrasound for Tremor in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02614989
- Acronym / sponsor ID
- 0556-15-RMB
- Conditions
- Multiple Sclerosis
- Keywords
- Tremor, Thalamotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Nov 2015 (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.
This project goal is to explore the option of (MRgFUS) as a treatment for tremor in MS patients with disabling refractory tremor.
Detailed description
This study is designed as a prospective, single site, single arm, nonrandomized study. Assessments will be made before and after MRgFUS for clinical symptom relief, quality of life (QoL) improvements, and safety of MRgFUS in the treatment of multiple sclerosis patients with severe medication refractory tremor.
This study will be performed on the 3T MR scanners. The ExAblate system is a medical device that involves a focused ultrasound system and an MRI scanner. During MRgFUS a pulse of focused ultrasound energy, or sonication,are delivered to the targeted tissue. In this particular study the targeted tissue is a unilateral thermal lesion created in the ventralis intermedius nucleus of the thalamus.
The treatment begins with a series of standard diagnostic MR images to identify the location and shape of tumor to be treated. The computer uses the physician's designation of the target volume to plan the best way to cover the target volume with small spots called "sonications". These treatment spots are cylinder shaped. Their size depends on sonication power and duration. During the treatment, a specific MR scan, which can be processed to identify changes in tissue temperature, provides a thermal map of the treatment volume to confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress, and confirm that the ablation is proceeding according to plan, thus closing the therapy loop.
MRgFUS uses a transcranial operated helmet-shaped transducer positioned above the subject head. The transcranial system includes means to immobilize the subject head, cool the interface water, and software for CT analysis and phase correction computation.
MRgFUS transcranial system to relieve tremor in multiple sclerosis patients is being investigated in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI guided Focused Ultrasound treatment | Experimental | Procedure: MRI guided focused ultrasound thalamotomyMRI guided focused ultrasound thalamotomy Patients will undergo unilateral thalmotomy using MRI guided Focused Ultrasound intervention for the treatment of the tremor |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women, age 18 years and older
- Patients who are able and willing to give informed consent and able to attend all study visits
- Patients with a diagnosis of Multiple sclerosis (MS) as confirmed from clinical history and examination by a neurologist.
- The patient must have disabling tremor from MS as indicated by a score of at least 2 on the Tremor Rating Scale (TRS) baseline global assessments by the examiner and the patient. Or Disabling is defined as significant impairment of the normal functions of daily life as indicated by a score of at least 5 on the Clinical Global Impression (CGI)-Severity scale.or ETRS
- The MS patient must have disabling and medically refractory unilateral or bilateral upper extremity tremor. Patients with associated ipsilateral lower extremity tremor are not excluded.
Key exclusion criteria (14 listed)
- Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Significant claustrophobia
- Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
- Subjects with unstable cardiac status
- Severe hypertension
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 |
|---|---|---|
| MRI guided focused ultrasound thalamotomyMRI guided focused ultrasound thalamotomy | Procedure or surgery | MRI guided Focused Ultrasound treatment |
Primary outcome
Device or procedure related adverse events reported
Time frame: 3 months
Safety of the MRI guided focused Ultrasound treatment will be determined by an evaluation of the incidence and severity of device and procedure related complications from the first / treatment day visit through the 3-Months post-treatment time point. All AEs will be reported.
1 secondary outcome
Tremor rating scale
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing MRI guided focused ultrasound thalamotomy in people with Multiple Sclerosis, run by Rambam Health Care Campus.
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 7 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 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Ilana Schlesinger, M.D. (97247771495, movement@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device or procedure related adverse events reported (time frame: 3 months). 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 25 Nov 2015.