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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

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).

Condition or disease Intervention/treatment Phase
Spinocerebellar Ataxia Other: Motor training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Slowing Down Disease Progression in Premanifest SCA: a Piloting Interventional Exergame Trial
Study Start Date : August 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : May 2017


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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).

  3. Ataxia severity [ Time Frame: Day 43 ]
    Clinical ataxia severity according to the Scale for the Assessment and Rating of Ataxia (SARA)

  4. Daily activity [ Time Frame: Day 43 ]
    Objectively measured level of daily activity in subjects' real-world settings (body-worn motions sensors; ActivePal®)

  5. Brain-derived neurotrophic factor [ Time Frame: Day 43 ]
    Increase of serum brain-derived neurotrophic factor (BDNF)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867969


Contacts
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Contact: Matthis Synofzik, PD Dr. +49-7071-2982060 matthis.synofzik@uni-tuebingen.de
Contact: Winfried Ilg, Dr. +49-7071-2989125 winfried.ilg@uni-tuebingen.de

Locations
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Germany
University Hospital Recruiting
Tuebingen, Baden-Württemberg, Germany, 72076
Contact: Matthis Synofzik, PD Dr.    +49-7071-2982060    matthis.synofzik@uni-tuebingen.de   
Contact: Winfried Ilg, Dr.    +49-7071-2989125    winfried.ilg@uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02867969     History of Changes
Other Study ID Numbers: SlowSCA
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital Tuebingen:
Spinocerebellar ataxia
Exergaming
Neurodegenerative diseases
Rare disease
Motor exercises
Premanifest stage
Training

Additional relevant MeSH terms:
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Ataxia
Spinocerebellar Ataxias
Spinocerebellar Degenerations
Disease Progression
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Disease Attributes
Pathologic Processes
Cerebellar Ataxia
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn