Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04576676
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2020-09-29
Brief Title:
Environmental Epidemiology of Essential Tremor
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Environmental Epidemiology of Essential Tremor
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RULET
Brief Summary:
This studys research is devoted to studying the causes of tremor and especially essential tremor ET which is the most common type of tremor Previous studies have revealed a link between harmane HA a dietary neurotoxin and ET these studies now also suggest a link between this toxin and Parkinsons disease PD a related tremor disorder Yet these links are tentative rather than conclusively established therefore in this new patient-based proposal which incorporates investigations spanning two continents North America and Europe utilizes several complementary study designs prospective cohort case control and draws on several types of tissue blood brain the investigators goal is to nail down the links between HA and ET and to further solidify the emerging links between HA and PD
Detailed Description:
This research is devoted to studying the causes of tremor and especially essential tremor ET which is the most common type of tremor Since 2000 this lab has been investigating whether several environmental neurotoxins are associated with ET A link between harmane HA 1-methyl-9H-pyrido34-bindole and ET has been emerging from these studies which show that blood and brain HA concentration HA is elevated in ET cases esp familial ET vs control subjects HA is a neurotoxin present in the diet esp in meat Administration of HA to laboratory animals produces severe action tremor resembling ET Yet the link between HA and ET has not been convincingly established All epidemiological studies have been case-control studies thus it is not clear whether high blood HA precedes the onset of ET Aim 1 of this proposal will address this issue The HA story has also become more complex and multi-dimensional Thus the investigators were recently intrigued to find that blood HA was higher in Parkinsons disease PD cases than controls in New York HA is structurally similar to MPTP a neurotoxin closely linked with PD ET and PD are both tremor disorders some patients develop both disorders ETPD ie they are comorbid for the two conditions Whether the HA - PD link is reproducible whether it tracks with the subtype of PD in which tremor rather than bradykinesiarigidity is the predominant feature and whether biomarker findings from blood also occur in the target organ of interest ie the brain in PD is not known Aim 2 of this proposal will address this myriad of issues Finally whether individuals who are comorbid for both ET and PD have the highest blood HA is not known Aim 3 of this proposal will address this issue To close these gaps in knowledge in this application the investigators propose a 5-year study with 3 inter-related aims that draw on several types of human tissue blood brain AIM 1 To nail down the links between HA and ET by studying the association between baseline blood HA and the development of incident ET in a cohort study AIM 2 To further solidify the emerging links between HA and PD by extending our observations to another country Spain AIM 3 To assess blood levels of HA in patients who have both ET and PD ETPD This would be the only study heading in this direction - exploring the etiological role of environmental factors and more specifically toxins in ET It would thus complement the many ongoing studies searching for ET genes The study could lead to the clear identification of the first modifiable risk factor for ET ie dietary HAThis would also be the only study assessing the possible etiological role and tissue concentrations of this toxin HA which is structurally similar to MPTP in patients with PD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NS094607 | NIH | None | httpsreporternihgovquickSearchR01NS094607 |