Atypical ParkinsonismFUSAPNCT06204575
Focused Ultrasound Thalamotomy for Tremor Relief in Atypical Parkinsonism
An observational study of Atypical Parkinsonism and Dementia With Lewy Bodies, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The goal of this retrospective observational study is to describe the efficacy of focused ultrasound ventral-intermediate nucleus thalamotomy in patients with atypical parkinsonism. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atypical Parkinsonism, Dementia With Lewy Bodies, Multiple System Atrophy, MSA
- What is being tested?
- Data collection
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2013to 31 May 2023
- 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 FUS VIM-thalamotomy and suffered from MSA or DLBD
Who may be able to join
None listed.
Who cannot join
- Patients that did not underwent FUS ventral-intermediate nucleus thalamotomy
- Patients that underwent FUS ventral-intermediate nucleus thalamotomy and do not suffer from MSA or DLBD
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this retrospective observational study is to describe the efficacy of focused ultrasound ventral-intermediate nucleus thalamotomy in patients with atypical parkinsonism.
- Is this treatment efficacious in patients with multiple system atrophy?
- Is this treatment efficacious in patients with diffuse Lewy Body Dementia? Data will be collected from patients charts.
- Being tested
- Data collection
- Keywords
- focused ultrasound, tremor, surgery, thalamotomy
- Medical subject headings
- Lewy Body Disease, Multiple System Atrophy, Thyroid Dyshormonogenesis 2A, 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.
Clinical Rating Scale for Tremor
tremor assessment by Clinical Rating Scale for Tremor. Scores ranging from 0 to 156, with higher scores indicating more severe tremor.
Measured: baseline, pre-procedure, 1 month, 6 months and 1 year following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Nov 2013
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical ParkinsonismStudies 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
- 8 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204575
- Sponsor's protocol ID
- RMB-0404-17
- Acronym
- FUSAP
- Status last verified
- Jan 2024
- First submitted
- 31 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- 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 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Ultrasound Thalamotomy for Tremor Relief in Atypical Parkinsonism
- ClinicalTrials.gov ID
- NCT06204575
- Acronym / sponsor ID
- FUSAP / RMB-0404-17
- Keywords
- focused ultrasound, tremor, surgery, thalamotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 12 Jan 2024 (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 goal of this retrospective observational study is to describe the efficacy of focused ultrasound ventral-intermediate nucleus thalamotomy in patients with atypical parkinsonism.
- Is this treatment efficacious in patients with multiple system atrophy?
- Is this treatment efficacious in patients with diffuse Lewy Body Dementia? Data will be collected from patients charts.
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 FUS VIM-thalamotomy and suffered from MSA or DLBD
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patients that did not underwent FUS ventral-intermediate nucleus thalamotomy
- Patients that underwent FUS ventral-intermediate nucleus thalamotomy and do not suffer from MSA or DLBD
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
Clinical Rating Scale for Tremor
Time frame: baseline, pre-procedure, 1 month, 6 months and 1 year following procedure
tremor assessment by Clinical Rating Scale for Tremor. Scores ranging from 0 to 156, with higher scores indicating more severe tremor.
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 12 Jan 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atypical Parkinsonism and Dementia With Lewy Bodies, run by Rambam Health Care Campus at 1 site in Israel.
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 0 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 12 Jan 2024. 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 Israel. 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.
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: baseline, pre-procedure, 1 month, 6 months and 1 year following procedure). 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 12 Jan 2024.