Ignite Creation Date:
2024-05-06 @ 12:12 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03706391
Status:
COMPLETED
Last Update Posted:
2023-01-20
First Post:
2018-10-11
Brief Title:
Study of ALS Reversals 4 LifeTime Exposures
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Study of ALS Reversals 4 LifeTime Exposures
Status:
COMPLETED
Status Verified Date:
2020-07
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:
StARLiTE
Brief Summary:
Hypothesis There exists patients who have met ALS or PMA diagnostic criteria and subsequently experienced robust and sustained improvement ie a reversal Thirty-eight of these patients were identified in the prior Duke University study Documentation of Known ALS Reversals StAR Protocol 1 Duke IRB Pro00076395 The investigators hypothesize these patients have had different environmental exposures than patients with typically progressive ALS Identification of specific environmental influences may point to exposures which are protective or exposure that lead to the development of a rare and novel reversible ALS-like disease
Objective This study seeks to identify environmental exposures associated with ALS reversals
Objective This study seeks to identify environmental exposures associated with ALS reversals
Detailed Description:
Amyotrophic Lateral Sclerosis ALS is a devastating motor neuron disease that typically causes rapidly progressive muscle weakness disability and premature death In spite of a large number of attempted ALS trials there are no significant disease-modifying therapies for this condition to-date
There exists a small group of patients who meet diagnostic criteria for ALS or progressive muscular atrophy PMA progress for a period of time and then significantly improve Some of these ALS reversals even make a complete recovery back to normal neurological function The investigators have independently verified 38 of these cases so far through review of medical records and peer-reviewed literature These patients are different in their demographics and disease characteristics as compared to patients with more typically progressive ALS
One possible explanation for these cases is that these patients have had protective environmental exposures Another possible explanation is that these patients have had unique environmental exposures that led to a reversible form of ALS Study of these selected reversal patients may yield valuable clues to environmental mechanisms of ALS resistance
This is a pilot case-control study attempting to discover environmental exposure correlates to ALS reversals The investigators will recruit and enroll ALS reversal cases to fill out an online survey form about their life Topics include demographics employment history military service substance use physical activity family medical history disease progression residential history occupational exposures home exposures hobby exposures hormonal and reproductive history female identifying subjects only caffeine head and neck injuries electrical shocks health insurance subjective perception of the etiology of ALS and clinical features of disease Control participant data will come from a pre-existing database
There exists a small group of patients who meet diagnostic criteria for ALS or progressive muscular atrophy PMA progress for a period of time and then significantly improve Some of these ALS reversals even make a complete recovery back to normal neurological function The investigators have independently verified 38 of these cases so far through review of medical records and peer-reviewed literature These patients are different in their demographics and disease characteristics as compared to patients with more typically progressive ALS
One possible explanation for these cases is that these patients have had protective environmental exposures Another possible explanation is that these patients have had unique environmental exposures that led to a reversible form of ALS Study of these selected reversal patients may yield valuable clues to environmental mechanisms of ALS resistance
This is a pilot case-control study attempting to discover environmental exposure correlates to ALS reversals The investigators will recruit and enroll ALS reversal cases to fill out an online survey form about their life Topics include demographics employment history military service substance use physical activity family medical history disease progression residential history occupational exposures home exposures hobby exposures hormonal and reproductive history female identifying subjects only caffeine head and neck injuries electrical shocks health insurance subjective perception of the etiology of ALS and clinical features of disease Control participant data will come from a pre-existing database
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