Essential TremorNCT06941285
Montreal Cognitive Assessment Index Following MRI Guided Focused Ultrasound Thalamotomy
An observational study of Essential Tremor, run by Rambam Health Care Campus.
Trial summary
We assessed Montreal Cognitive Assessment scores before and after MRI guided focused ultrasound thalamotomy for tremor in order to identify if there are changes in cognitive function following treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Data collection
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2013to 1 Jun 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that underwent MRI guided focused ultrasound thalamotomy and suffered from Essential tremor.
Who may be able to join
- Patients that underwent MRI guided focused ultrasound thalamotomy and suffered from Essential tremor.
Who cannot join
- Patients that did not undergo MRI guided focused ultrasound thalamotomy
- Patinets that did not suffer from Essential tremor.
- Patients that underwent MRI guided focused ultrasound for areas other then a thalamus
- Patients tat underwent bilateral thalamothomy
About this study
Official title: Montreal Cognitive Assessment Index Following MRI Guided Focused Ultrasound
We assessed Montreal Cognitive Assessment scores before and after MRI guided focused ultrasound thalamotomy for tremor in order to identify if there are changes in cognitive function following treatment.
Read the detailed description
All patients who underwent MRI guided focused ultrasound thalamotomy underwent cognitive assessment by Montreal Cognitive Assessment. We calculated the scores before and after treatment and compared the results.
- Conditions
- Essential Tremor
- Being tested
- Data collection
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment
Cognitive assessessment with higher score indicating better cognitive state
Measured: baselin, preprocedure, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Nov 2013
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential 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
- Retrospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilana Schlesinger, Rambam Health Care Campus
- Investigators
- Inna Senderova, Study director, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941285
- Sponsor's protocol ID
- RMB0404-17
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montreal Cognitive Assessment Index Following MRI Guided Focused Ultrasound
- ClinicalTrials.gov ID
- NCT06941285
- Acronym / sponsor ID
- RMB0404-17
- Conditions
- Essential Tremor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 23 Apr 2025 (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.
We assessed Montreal Cognitive Assessment scores before and after MRI guided focused ultrasound thalamotomy for tremor in order to identify if there are changes in cognitive function following treatment.
Detailed description
All patients who underwent MRI guided focused ultrasound thalamotomy underwent cognitive assessment by Montreal Cognitive Assessment. We calculated the scores before and after treatment and compared the results.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that underwent MRI guided focused ultrasound thalamotomy and suffered from Essential tremor.
Key inclusion criteria (1 listed)
- Patients that underwent MRI guided focused ultrasound thalamotomy and suffered from Essential tremor.
Key exclusion criteria (4 listed)
- Patients that did not undergo MRI guided focused ultrasound thalamotomy
- Patinets that did not suffer from Essential tremor.
- Patients that underwent MRI guided focused ultrasound for areas other then a thalamus
- Patients tat underwent bilateral thalamothomy
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 |
|---|---|---|
| Data collectionData collection | Other | – |
Primary outcome
Montreal Cognitive Assessment
Time frame: baselin, preprocedure, 6 months and 1 year
Cognitive assessessment with higher score indicating better cognitive state
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 23 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Inna Senderova study director
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
An observational study of Essential 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 1 inclusion and 4 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 23 Apr 2025. 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?
Montreal Cognitive Assessment (time frame: baselin, preprocedure, 6 months and 1 year). 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 23 Apr 2025.