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OpenTrials
Completed

NCT Number: NCT04837027

Effect of Training on Brain Volume in Ataxia

The primary aim is to show balance training improves DCD individual's ability to compensate for their activity limitations, but does not impact disease progression.

The second aim is to demonstrate aerobic exercise improves balance and gait in DCD persons by affecting brain processes and slowing cerebellar atrophy.

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Key information

About this study

Individuals with degenerative cerebellar disease (DCD) exhibit gradual loss of coordination resulting in impaired balance, gait deviations, and severe, progressive disability. With no available disease-modifying medications, balance training is the primary treatment option to improve motor skills and functional performance. There is no evidence, however, that balance training impacts DCD at the tissue level.

Aerobic training, on the other hand, may modify DCD progression as evident from animal data. Compared to sedentary controls, aerobically trained DCD rats have enhanced lifespan, motor function, and cerebellar Purkinje cell survival. Numerous animal studies also document that aerobic training has a direct, favorable effect on the brain that includes production of neurotrophic hormones, enhancement of neuroplasticity mechanisms, and protection from neurotoxins.

The effects of aerobic training in humans with DCD are relatively unknown, despite these encouraging animal data. A single study to date has evaluated the benefits of aerobic exercise on DCD in humans, and this was a secondary outcome of the study. Although participants performed limited aerobic training during the study, modest functional benefits were still detected.

The main objective of this project will be to compare the benefits of aerobic versus balance training in DCD. We hypothesize that both aerobic and balance training will improve function in DCD subjects, but that the mechanisms in which these improvements occur differ. 1) Balance training improves DCD individual's ability to compensate for their activity limitations, but does not impact disease progression. 2) Aerobic exercise improves balance and gait in DCD persons by impacting the cerebellum

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with spinocerebellar ataxia
  • Cerebellar atrophy on MRI
  • Prevalence of ataxia on clinical exam
  • Ability to safely ride a stationary exercise bike

Exclusion criteria

  • Other neurologic conditions • Heart disease
  • Cognitive impairment
  • Medical instability

Treatment and study plan

Aerobic training

Behavioral

Aerobic training on stationary bike 5x a week for 30 minutes a day

Balance training

Behavioral

Training 5x a week for 30 minutes. Standard of care

Primary outcomes

  1. Cerebellar volume

    Time frame: 6 months

    Cranial MRI will be performed in all participants using a 3-T scanner. Using each individual's T1-weighted image, structural imaging measures of cerebellar brain volume will be derived using the FreeSurfer software package (http:// surfer.nmr.mgh.harvard.edu/). FreeSurfer will automatically assign a neuroanatomic label to each voxel. From this labeling, a set of volumetric regions of interest is defined. The calculated volume within the cerebellar region is adjusted for variations in individual's intracranial brain volume (ICV) which is measured using BrainWash (an automatic

    • Page 3 of 5 [DRAFT] -

    multi-atlas skull-striping software package). We will process the longitudinal T1-weighted images

Secondary outcomes

  1. Cognition

    Time frame: 6 months

    The NIH toolbox will be used before and after training to determine impact of training on cognition

  2. Ataxia severity

    Time frame: 6 months

    The Scale for the Assessment and Rating of Ataxia (SARA) will be done to before and after training. This scale ranges from 0 to 40 with higher scores indicating more ataxia

  3. Gait speed

    Time frame: 6 months

    Participants will walk 8 meters as fast as possible

  4. Balance

    Time frame: 6 months

    The dynamic gait index will be performed to test balance

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Balance Versus Aerobic Training in Degenerative Cerebellar Diseases

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2021
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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