Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT02867969
Eligibility Criteria:
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 elevated body temperatures or warming of body parts.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02867969
Study Brief:
Protocol Section:
NCT02867969