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

NCT ID: NCT02867969

Last Updated: 2016-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-05-31

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.

Conditions

Spinocerebellar Ataxia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Motor training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Exergaming

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital

Tübingen, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Matthis Synofzik, PD Dr.

Role: CONTACT

matthis.synofzik@uni-tuebingen.de

+49-7071-2982060

Winfried Ilg, Dr.

Role: CONTACT

winfried.ilg@uni-tuebingen.de

+49-7071-2989125

Facility Contacts

Matthis Synofzik, PD Dr.

Role: primary

matthis.synofzik@uni-tuebingen.de

+49-7071-2982060

Winfried Ilg, Dr.

Role: backup

winfried.ilg@uni-tuebingen.de

+49-7071-2989125

Other Identifiers

SlowSCA

Identifier Type: -

Identifier Source: org_study_id