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

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ClinicalTrials.gov Identifier: NCT02867969
Recruitment Status : Unknown
Verified August 2016 by University Hospital Tuebingen.
Recruitment status was:  Recruiting
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Tracking Information
First Submitted Date  ICMJE August 11, 2016
First Posted Date  ICMJE August 16, 2016
Last Update Posted Date August 16, 2016
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
Gait score [ Time Frame: Day 43 ]
Decrease in a quantitative composite gait score consisting of body sway and gait variability in walking challenge conditions (mattress), assessed by VICON-based motion tracking
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
  • Brain networks captured [ Time Frame: Day 43 ]
    Changes 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 parameters [ Time Frame: Day 43 ]
    Set of quantitative movement parameters for complex whole-body movements (gait, stand, fast sequences of goal-directed stepping movements) (VICON-based motion tracking).
  • Ataxia severity [ Time Frame: Day 43 ]
    Clinical ataxia severity according to the Scale for the Assessment and Rating of Ataxia (SARA)
  • Daily activity [ Time Frame: Day 43 ]
    Objectively measured level of daily activity in subjects' real-world settings (body-worn motions sensors; ActivePal®)
  • Brain-derived neurotrophic factor [ Time Frame: Day 43 ]
    Increase of serum brain-derived neurotrophic factor (BDNF)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Slowing Down Disease Progression in Premanifest SCA: a Piloting Interventional Exergame Trial
Official Title  ICMJE Slowing Down Disease Progression in Premanifest SCA: a Piloting Interventional Exergame Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Spinocerebellar Ataxia
Intervention  ICMJE Other: Motor training
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.
Other Name: Exergaming
Study Arms  ICMJE Motor training
The motor training comprise of demanding coordinative exercises based on commercially available developed by Microsoft Game Console (XBOX Kinect™) exergames that specifically target ataxia dysfunctions.
Intervention: Other: Motor training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 11, 2016)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2017
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02867969
Other Study ID Numbers  ICMJE SlowSCA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital Tuebingen
Study Sponsor  ICMJE University Hospital Tuebingen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital Tuebingen
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP