Slowing Down Disease Progression in Premanifest SCA: a Piloting Interventional Exergame Trial (NCT02867969) | Clinical Trial Compass
UnknownNot Applicable
Slowing Down Disease Progression in Premanifest SCA: a Piloting Interventional Exergame Trial
Germany26 participantsStarted 2016-08
Plain-language summary
This is a piloting study using continuous motor training provided via whole body-controlled video games (exergames) to establish proof-of-concept evidence that such training leads to motor and neural changes in pre-manifest subjects with spinocerebellar ataxias (SCA).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* adult persons (age 18-80 years) who (i) are a blood-related relative of an index subject with a known SCA 1,2,3 or 6 mutation and who (ii) have a score value of \<8 points on the Scale for the Assessment and Rating of Ataxia (SARA)
* full capacity to consent to study participation after extensive information (fully Informed Consent)
Exclusion Criteria:
* Cognitive deficits which prevent full comprehension of the study requirements and/or training requirements
* Comorbid diseases that place severe constraints on a continous training with whole-body controlled exergames (e.g. severe visual or hearing deficits; severe paresis; severe movement disorders other than ataxia)
* Comorbid neurologic disease other than ataxia (e.g. prior stroke or brain trauma)
* Pregnant or breast-feeding persons
* Lack of capacity for full informed consent according to established psychiatric criteria for full informed consent
Magnetic Resonance Imaging (MRI) exclusion criteria:
* cardiac pacemakers
* artificial heart valves
* metal prostheses
* implanted magnetic metal parts (screws, plates and similar devices)
* intrauterine devices (for instance, for contraceptive purposes)
* shrapnel parts and other metal pieces
* non-removable braces and metal dentures
* non-removable acupuncture needles
* insulin pumps and infusion ports
* tattoos, eye shadow and other metal-containing make-up
* The subject has decreased sensitivity to temperature and / or decreased tolerance towards e…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.