Study of ALS Reversals 4: LifeTime Exposures
Completed
Conditions studied: Amyotrophic Lateral Sclerosis, Progressive Muscular Atrophy, Motor Neuron Disease
In brief
Hypothesis: There exists patients who have met ALS or PMA diagnostic criteria and subsequently experienced robust and sustained improvement, i.e. a "reversal." Thirty-eight of these patients were identified in the prior Duke University study, Documentation of Known ALS Reversals (St.A.R. 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.
Key facts
- Study ID
- NCT03706391
- Run by
- Duke University
- People needed
- 25
- Starts
- 2018-09-26
- Expected to finish
- 2020-06-01
- Last updated by the study team
- 2023-01-20
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Prior participation in Documentation of Known ALS Reversals (Duke IRB Pro00076395)
- Confirmation of ALS or PMA (primary muscular atrophy) diagnosis through medical record review (previously documented in Documentation of Known ALS Reversals protocol)
- Sustained, robust improvement on at least one objective ALS outcomes measure (ex. ALSFRS-R, FVC, strength testing, EMG) (previously documented in Documentation of Known ALS Reversals protocol)
- Able to understand English
You may not qualify if…
- History of cognitive impairment severe enough to preclude informed consent, reported by patient on direct questioning or as suspected by research personnel from Documentation of Known ALS Reversals (Duke IRB Pro00076395) study data
Where it is running
- Duke ALS Clinic / DUSOM Dept of Neurology / DUHS — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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