Clinical trial NCT05002218: Training in Ataxia - Individuals With Degenerative Cerebellar Diseases
Official title: The Neural Effects of Balance Versus Aerobic Training in Individuals With Degenerative Cerebellar Diseases
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebellar Ataxia
Keywords: ataxia
cerebellar ataxia
exercise
training
rehabilitation
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2021-08-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-blinded randomized control trial.
Primary purpose: TREATMENT

Brief summary: Balance and aerobic training show promise as treatments for degenerative cerebellar diseases, but the neural effects of both training methods are unknown. The goal of this project is to evaluate how each training method impacts the brain, and particularly, the degenerating cerebellum. Various neuroimaging techniques will be used to accomplish this goal and test the hypothesis that balance training impacts brain structures outside the cerebellum whereas aerobic training causes more neuroplastic changes within the cerebellum.

Detailed description: Degenerative cerebellar diseases are a group of disorders that cause severe disability and can be fatal. There are currently no known disease-modifying treatments available for use, and there is a critical need to find treatments that slow disease progression and allow affected individuals to live more functional lives. Balance and aerobic training show promise as treatments for degenerative cerebellar diseases, but the neural effects of both training methods have not been thoroughly investigated. It is crucial to understand how the training impacts the brain, and particularly the cerebellum, in order to determine if one training method is better at slowing disease progression than the other. The goal of this proposal is to compare the neural effects of balance versus aerobic training in individuals with degenerative cerebellar diseases. The investigator hypothesizes that aerobic training causes neuroplastic changes within the cerebellum whereas balance training causes improvements for people with cerebellar degeneration by impacting brain structures outside the cerebellum. If this hypothesis is true, aerobic training may have more influence on disease progression than balance training as it directly impacts the cerebellum.

To investigate the hypothesis, various neuroimaging techniques will be used. In AIM 1, the investigator will compare cerebellar volume before and after the participants perform either 6-months of balance or aerobic training. In AIM 2, the investigator will investigate whether neural changes have clinical significance by correlating cerebellar volume changes with clinical measures of ataxia. Finally, for AIM 3, the investigator will use diffusion tensor imaging and resting state fMRI scans to examine how both training methods impact cerebellar microstructure and functional cerebellar connections. The investigator hopes that a detailed understanding of how each training method impacts the cerebellum will lead to more targeted training regimens with the goal of slowing disease progression of these devastating diseases.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Assessment and Rating of Ataxia (SARA) Score
timeFrame: Baseline, 6 months, 9 months, 12 months
Secondary outcomes:
measure: Average gait speed
timeFrame: Baseline, 6 months, 9 months, 12 months
measure: Dynamic Gait Index score
timeFrame: Baseline, 6 months, 9 months, 12 months
measure: Prevalence of desired changes in Diffuse Tensor Imaging
timeFrame: 6 months
measure: Prevalence of desired changes in Resting State fMRI scans
timeFrame: 6 months
measure: Prevalence of Cerebellar Volume
timeFrame: Baseline, 6 months, 9 months, 12 months
measure: Timed Up and Go
timeFrame: Baseline, 6 months, 9 months, 12 months
measure: Quality of life-brief
timeFrame: 0,6,9,12 months
measure: Fatigue severity scale
timeFrame: 0,6,9,12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Assistant Professor of Rehabilitation and Regenerative Medicine
name: Scott M Barbuto, MD
role: PRINCIPAL_INVESTIGATOR
References: