Dementia With Lewy Bodies Clinical Trial
— FUSAPOfficial title:
Focused Ultrasound Thalamotomy for Tremor Relief in Atypical Parkinsonism
| NCT number | NCT06204575 |
| Other study ID # | RMB-0404-17 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 1, 2013 |
| Est. completion date | May 31, 2023 |
| Verified date | January 2024 |
| Source | Rambam Health Care Campus |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | May 31, 2023 |
| Est. primary completion date | May 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Patients that underwent FUS ventral-intermediate nucleus thalamotomy Suffer from multiple system atrophy-Parkinsonian type (MSA-P) or dementia with Lewy bodies (DLBD). - Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Rambam Health Care Campus | Haifa |
| Lead Sponsor | Collaborator |
|---|---|
| Rambam Health Care Campus |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | baseline, pre-procedure, 1 month, 6 months and 1 year following procedure |
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