Disease Natural History and Biomarkers of SPG3A, SPG4A, and SPG31
Stopped early
Conditions studied: Hereditary Spastic Paraplegia
In brief
Background: Hereditary spastic paraplegia (HSP) usually progresses slowly. Researchers want to learn more about how its symptoms change over time. They want to look for changes in the blood and cells of people with the most common forms of HSP that might allow them to better understand the disease. Objectives: To learn more about common forms of hereditary spastic paraplegia and find out how it progresses over time. Eligibility: People age 7 and older with SPG3A, SPG4A, or SPG31 Design: Participants will have 1 two-hour visit each year for up to 5 years. At 1 visit, adult participants may have a skin biopsy. An area of skin will be numbed then a tool will remove a small piece of skin. At all visits, all participants will have a physical exam and blood drawn. At all visits, participants will do a few tasks like walking quickly and climbing stairs. Participants can give permission for their skin cells, DNA samples, and data to be used in other studies. The samples and data will have no identifying information.
Key facts
- Study ID
- NCT02859428
- Run by
- National Institute of Neurological Disorders and Stroke (NINDS)
- People needed
- 51
- Starts
- 2016-11-18
- Expected to finish
- 2020-10-16
- Last updated by the study team
- 2020-10-20
Who can join
Age: 7 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Adults unable to provide consent or minors without a parent or a guardian.
- Unwillingness to consent for collection of biological samples or their cryopreservation.
- Any bleeding disorder that would prevent or present any danger either during blood extraction or skin biopsy, such hemophilia, or the long-term use of anticoagulants such as Coumadin.
- For the subcomponent of this study involving transcranial magnetic stimulation (TMS), performed with nerve conduction studies:
- Patients under 18 years of age.
- Patients withwith implanted devices, such as pacemakers, pumps or stimulators.
- Patients withor metal in the cranium (excluding dental work) or eye.
- Patients with known seizure disorder.
- Patients who are unwilling or unable to participate.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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