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 range18 Years – 80 Years
SexALL
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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…