TremorMRgFUSNCT03300193
The Effect of Lesion Characteristics in MRgFUS on Tremor in Essential Tremor and Parkinson's Disease
An observational study of Tremor, run by Rambam Health Care Campus.
Trial summary
The study will investigate Essential Tremor and Parkinson's Disease patients who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS). We will evaluate the effect of lesion characteristics on tremor and on quality of life after the procedure as compared with the baseline prior to the procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tremor
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- May 2016to 31 May 2017
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients which were diagnosed with ET or Idiopathic PD with medication refractory tremor that underwent MRgFUS procedure.
Who may be able to join
- Men and women, between 18 and 80 years.
- Patients who underwent the MRgFUS procedure.
- Patients who are able and willing to give consent and able to attend all study visits and Radiologic follow-up examination by MRI.
- A diagnosis of ET or Idiopathic PD as confirmed from clinical history and examination preformed by a movement disorders neurologist.
- ET patients: tremor severity score of greater than or equal to 2 in the treated hand/arm as measured by postural or action item on the Clinical Rating Scale for Tremor (CRST).
- PD patients: tremor severity score of equal or greater than 3 on either item 20 or item 21 of motor part in the Unified PD Rating Scale (UPDRS).
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- Substantial disability in the performance of at least two daily activities from the disability subsection of the scales UPDRS for PD patients or CRST for ET patients.
- The patient must have a history of an unsatisfactory response to medical management. All patients 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.
- Stable doses of all medications for 30 days prior to study entry.
Who cannot join
- Patients which have not completed the MRgFUS procedure.
- Patients which were diagnosed during the trial with additional diagnoses that can affect motor function, quality of life and symptoms of tremor.
About this study
Official title: The Effect of Lesion Characteristics in Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS) on Tremor in Essential Tremor and Parkinson's Disease
The study will investigate Essential Tremor and Parkinson's Disease patients who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS). We will evaluate the effect of lesion characteristics on tremor and on quality of life after the procedure as compared with the baseline prior to the procedure.
Read the detailed description
The purpose of the study is to investigate the effect of lesion characteristics in ExAblate Transcranial Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) of the Vim thalamic nucleus. Clinical measures will be used to study patients suffering from medication-refractory tremor, Essential Tremor or idiopathic Parkinson's Disease.
This study is designed as a prospective, observational, and clinical study. Assessments will be made before and after MRgFUS for; clinical tremor relief, quality of life (QoL) improvements, assessment of adverse events, and correlations of these measures with the size and shape of the lesion and the surrounding edema .
- Conditions
- Tremor
- Keywords
- Magnetic Resonance guided Focused Ultrasound, Tremor, Essential Tremor, Parkinson's Disease
- Medical subject headings
- Tremor, Essential Tremor, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tremor patients | Essential Tremor and Parkinson's Disease patients with Tremor refractory to pharmacological therapy who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Rating Scale for Tremor
Tremor score: In ET patients - Clinical Rating Scale for Tremor (CRST)
Measured: 3 MONTHS
Motor part of Unified PD Rating Scale
In PD patients - Motor part of Unified PD Rating Scale (UPDRS)
Measured: 3 MONTHS
Secondary outcomes (3)
Quality of Life Essential Tremor Questionnaire
Quality of life: Quality of Life Essential Tremor Questionnaire (QUEST)
Measured: 3 MONTHS
Parkinson's Disease Questionnaire
Parkinson's Disease Questionnaire (PDQ39)
Measured: 3 MONTHS
iSeismometer application
For all patients: iSeismometer application for mobile phone for Assessment of tremor amplitude and frequency before and after the procedure.
Measured: 3 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study startMay 2016
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TremorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menashe Zaaroor, MD PhD, Rambam Health Care Campus
- Investigators
- Menashe Zaaroor, MD, DSc, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300193
- Sponsor's protocol ID
- 0162-15-RMB
- Acronym
- MRgFUS
- Status last verified
- Sep 2017
- First submitted
- 29 May 2016
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: IPD
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lesion Characteristics in Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS) on Tremor in Essential Tremor and Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03300193
- Acronym / sponsor ID
- MRgFUS / 0162-15-RMB
- Conditions
- Tremor
- Keywords
- Magnetic Resonance guided Focused Ultrasound, Tremor, Essential Tremor, Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 3 Oct 2017 (actual)
- 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 study will investigate Essential Tremor and Parkinson's Disease patients who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS). We will evaluate the effect of lesion characteristics on tremor and on quality of life after the procedure as compared with the baseline prior to the procedure.
Detailed description
The purpose of the study is to investigate the effect of lesion characteristics in ExAblate Transcranial Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) of the Vim thalamic nucleus. Clinical measures will be used to study patients suffering from medication-refractory tremor, Essential Tremor or idiopathic Parkinson's Disease.
This study is designed as a prospective, observational, and clinical study. Assessments will be made before and after MRgFUS for; clinical tremor relief, quality of life (QoL) improvements, assessment of adverse events, and correlations of these measures with the size and shape of the lesion and the surrounding edema .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tremor patients | – | –Essential Tremor and Parkinson's Disease patients with Tremor refractory to pharmacological therapy who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients which were diagnosed with ET or Idiopathic PD with medication refractory tremor that underwent MRgFUS procedure.
Key inclusion criteria (9 listed)
- Men and women, between 18 and 80 years.
- Patients who underwent the MRgFUS procedure.
- Patients who are able and willing to give consent and able to attend all study visits and Radiologic follow-up examination by MRI.
- A diagnosis of ET or Idiopathic PD as confirmed from clinical history and examination preformed by a movement disorders neurologist.
- ET patients: tremor severity score of greater than or equal to 2 in the treated hand/arm as measured by postural or action item on the Clinical Rating Scale for Tremor (CRST).
Key exclusion criteria (2 listed)
- Patients which have not completed the MRgFUS procedure.
- Patients which were diagnosed during the trial with additional diagnoses that can affect motor function, quality of life and symptoms of tremor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Rating Scale for Tremor
Time frame: 3 MONTHS
Tremor score: In ET patients - Clinical Rating Scale for Tremor (CRST)
Motor part of Unified PD Rating Scale
Time frame: 3 MONTHS
In PD patients - Motor part of Unified PD Rating Scale (UPDRS)
3 secondary outcomes
Quality of Life Essential Tremor Questionnaire
Time frame: 3 MONTHS
Parkinson's Disease Questionnaire
Time frame: 3 MONTHS
iSeismometer application
Time frame: 3 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Individual participant dataSharing planned: Yes. IPD
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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.
Menashe Zaaroor, MD, DSc principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
An observational study of Tremor, 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 9 inclusion and 2 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: finished, as of the sponsor's last update on 3 Oct 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Rating Scale for Tremor (time frame: 3 MONTHS). The study lists 2 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 2017.