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Slowing Down Disease Progression in Premanifest SCA: a Piloting Interventional Exergame Trial

Slowing Down Disease Progression in Premanifest SCA: a Piloting Interventional Exergame Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02867969
Acronym
SlowSCA
Enrollment
26
Registered
2016-08-16
Start date
2016-08-31
Completion date
2017-05-31
Last updated
2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinocerebellar Ataxia

Keywords

Spinocerebellar ataxia, Exergaming, Neurodegenerative diseases, Rare disease, Motor exercises, Premanifest stage, Training

Brief 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).

Detailed description

In many neurodegenerative diseases, including spinocerebellar ataxias (SCA), large populations of neurons are already lost and compensatory resources exhausted at time of clinical diagnosis. This calls for early intervention strategies aiming to slow down disease progression already at the premanifest stage of the disease. Here we propose the world-first interventional study aiming to delay onset in a rare genetic neurodegenerative disease. Specifically, we propose 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 SCA subjects. The subclinical effects will be unravelled within an intraindividual control study design by elaborated quantitative Video Management System (VICON®)-based movement analysis and structural and functional 3 Tesla (T) magnetic resonance imaging. This will provide unique insights in underlying motor and neural networks and compensatory strategies. If successful, this piloting trial will provide the basis for a rigorous international multi-center large-scale study in a larger SCA population. Moreover, it will stimulate complementary tandem projects on effects of motor training on neural functioning and molecular pathways in premanifest SCA mouse models.

Interventions

The motor training will comprise of demanding coordinative exercises based on commercially available developed by Microsoft Game Console (XBOX Kinect™) exergames that specifically target ataxia dysfunctions.

Sponsors

University Hospital Tuebingen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Gait scoreDay 43Decrease in a quantitative composite gait score consisting of body sway and gait variability in walking challenge conditions (mattress), assessed by VICON-based motion tracking

Secondary

MeasureTime frameDescription
Brain networks capturedDay 43Changes in brain networks captured by specific neuroimaging focussing on brain grey matter volume (VBM), brain fibre tracking (DTI) and functional connectivity of the cerebellum with other brain regions (resting-state connectivity)
Quantitative movement parametersDay 43Set of quantitative movement parameters for complex whole-body movements (gait, stand, fast sequences of goal-directed stepping movements) (VICON-based motion tracking).
Ataxia severityDay 43Clinical ataxia severity according to the Scale for the Assessment and Rating of Ataxia (SARA)
Daily activityDay 43Objectively measured level of daily activity in subjects' real-world settings (body-worn motions sensors; ActivePal®)
Brain-derived neurotrophic factorDay 43Increase of serum brain-derived neurotrophic factor (BDNF)

Countries

Germany

Contacts

Primary ContactMatthis Synofzik, PD Dr.
matthis.synofzik@uni-tuebingen.de+49-7071-2982060
Backup ContactWinfried Ilg, Dr.
winfried.ilg@uni-tuebingen.de+49-7071-2989125

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026