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

Primary Purpose

Spinocerebellar Ataxia

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Motor training
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinocerebellar Ataxia focused on measuring Spinocerebellar ataxia, Exergaming, Neurodegenerative diseases, Rare disease, Motor exercises, Premanifest stage, Training

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Motor training

Arm Description

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.

Outcomes

Primary Outcome Measures

Gait score
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

Brain networks captured
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
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
Clinical ataxia severity according to the Scale for the Assessment and Rating of Ataxia (SARA)
Daily activity
Objectively measured level of daily activity in subjects' real-world settings (body-worn motions sensors; ActivePal®)
Brain-derived neurotrophic factor
Increase of serum brain-derived neurotrophic factor (BDNF)

Full Information

First Posted
August 11, 2016
Last Updated
August 11, 2016
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT02867969
Brief Title
Slowing Down Disease Progression in Premanifest SCA: a Piloting Interventional Exergame Trial
Acronym
SlowSCA
Official Title
Slowing Down Disease Progression in Premanifest SCA: a Piloting Interventional Exergame Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinocerebellar Ataxia
Keywords
Spinocerebellar ataxia, Exergaming, Neurodegenerative diseases, Rare disease, Motor exercises, Premanifest stage, Training

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motor training
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
Motor training
Other Intervention Name(s)
Exergaming
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gait score
Description
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
Time Frame
Day 43
Secondary Outcome Measure Information:
Title
Brain networks captured
Description
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)
Time Frame
Day 43
Title
Quantitative movement parameters
Description
Set of quantitative movement parameters for complex whole-body movements (gait, stand, fast sequences of goal-directed stepping movements) (VICON-based motion tracking).
Time Frame
Day 43
Title
Ataxia severity
Description
Clinical ataxia severity according to the Scale for the Assessment and Rating of Ataxia (SARA)
Time Frame
Day 43
Title
Daily activity
Description
Objectively measured level of daily activity in subjects' real-world settings (body-worn motions sensors; ActivePal®)
Time Frame
Day 43
Title
Brain-derived neurotrophic factor
Description
Increase of serum brain-derived neurotrophic factor (BDNF)
Time Frame
Day 43

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthis Synofzik, PD Dr.
Phone
+49-7071-2982060
Email
matthis.synofzik@uni-tuebingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Winfried Ilg, Dr.
Phone
+49-7071-2989125
Email
winfried.ilg@uni-tuebingen.de
Facility Information:
Facility Name
University Hospital
City
Tuebingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthis Synofzik, PD Dr.
Phone
+49-7071-2982060
Email
matthis.synofzik@uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Winfried Ilg, Dr.
Phone
+49-7071-2989125
Email
winfried.ilg@uni-tuebingen.de

12. IPD Sharing Statement

Plan to Share IPD
No

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

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