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Effect of Training on Brain Volume in Ataxia

Balance Versus Aerobic Training in Degenerative Cerebellar Diseases

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04837027
Enrollment
36
Registered
2021-04-08
Start date
2021-09-01
Completion date
2022-03-16
Last updated
2022-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinocerebellar Ataxias

Keywords

Ataxia, Cerebellum, Cerebellar degeneration

Brief summary

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.

Detailed description

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

Interventions

BEHAVIORALAerobic training

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

BEHAVIORALBalance training

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

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcome assessor will know that the participant has received balance or aerobic training, but will not be aware of which group the participant belonged.

Intervention model description

Single blinded randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cerebellar volume6 monthsCranial 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

MeasureTime frameDescription
Cognition6 monthsThe NIH toolbox will be used before and after training to determine impact of training on cognition
Ataxia severity6 monthsThe 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
Gait speed6 monthsParticipants will walk 8 meters as fast as possible
Balance6 monthsThe dynamic gait index will be performed to test balance

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026