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Completed

NCT Number: NCT03701776

Ataxia and Exercise Disease Using MRI and Gait Analysis

The first 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

Conditions

Ataxia Behavior Brain Diseases Central Nervous System Diseases Cerebellar Ataxia Cerebellar Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Motor Activity Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spino Cerebellar Degeneration Spinocerebellar Ataxias Spinocerebellar Degenerations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University/New York Presbyterian

New York, 10035, United States

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 affecting brain processes and slowing cerebellar atrophy.

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 bicycle for 30 minutes a day, 5 days a week for 6 months

Balance training

Behavioral

Standard of care

Primary outcomes

  1. Change in SARA scores

    Time frame: 6 months

    Ataxia severity will be measured using the Scale for the Assessment and Rating of Ataxia (SARA).17 SARA evaluates the degree of ataxia by measuring gait, stance, sitting balance, speech, finger-chase test, nose-finger test, fast alternating movements, and heel-shin test.

Secondary outcomes

  1. Change in gait parameters

    Time frame: 6 months

    For the walking assessment, participants will walk as fast as possible on a 10-meter runway six times, and we will average the times of trials 3-6. We will also collect marker position data from infrared emitting diodes placed bilaterally at the first and fifth metatarsal heads, heels, medial and lateral malleoli, medial and lateral condyles of the knee, head of the fibula, and anterior and posterior superior iliac crests pelvic crests using a three-dimensional Vicon motion capture system (Vicon, Denver, CO). Custom Nexus and Bodybuilder software will be used to calculate joint position and determine the following walking parameters: stride length, stride length variability, percent time in double limb support, and degree of pelvic rotation and tilt.

  2. Change in 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 multi-atlas skull-striping software package). We will process the longitudinal T1-weighted images using FreeSurfer longitudinal pipeline, recently implemented to detect small or subtle changes over time.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Effects of Aerobic Exercise Verse Balance Training on Degenerative Cerebellar Disease

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 10, 2018
Registry last updated
Nov 4, 2021

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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