Training in Ataxia - Individuals With Degenerative Cerebellar Diseases

Cerebellar Ataxia Clinical Trial

Official title:

The Neural Effects of Balance Versus Aerobic Training in Individuals With Degenerative Cerebellar Diseases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05002218
• Other study ID #: AAAT8388
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: December 31, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia
• Cerebellar Diseases

Intervention

Behavioral:
• Aerobic Training
Aerobic training on stationary bike 5x a week for 30 minutes a day.
• Balance Training
Balance training 5x a week for 30 minutes as instructed by a therapist. Standard of care.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Assessment and Rating of Ataxia (SARA) Score	This is to measure ataxia severity. The Scale for the Assessment and Rating of Ataxia (SARA) will be administered before and after training. SARA is an 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia) - with higher scores indicating ataxia. The scores are based on patient performance of gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movements and heel-shin slide.	Baseline, 6 months, 9 months, 12 months
Secondary	Average gait speed	This is to measure average time to complete 8-meter walk test. Participants will walk 8 meters as fast as possible three different times. Time will be measured in seconds per meter.	Baseline, 6 months, 9 months, 12 months
Secondary	Dynamic Gait Index score	The dynamic gait index (DGI) will be performed to asses balance. A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function. Total Score = 24. Patients will be asked to walk 20 feet and conditions such as speed and head position will be varied as previously described. The examiner will then grade the subject's movement.	Baseline, 6 months, 9 months, 12 months
Secondary	Prevalence of desired changes in Diffuse Tensor Imaging	Diffusion data will be preprocessed for motion and corrected for geometrical distortion using ExploreDTI. For each participant, the bmatrix will be reoriented to provide a more accurate estimate of diffusion tensor orientations. Diffusion tensor estimation will be performed using a non-linear least square fitting method. FA and Mean Diffusivity (MD) maps will be generated. Whole brain tractography will be performed using all brain voxels with FA = 0.2 as seed region.	6 months
Secondary	Prevalence of desired changes in Resting State fMRI scans	This measure will be a primary outcome for Aim 3. The anatomical and functional data will be pre-processed and analyzed using Statistical Parametric Mapping (SPM12) and the CONN toolbox Version 14p.	6 months
Secondary	Prevalence of Cerebellar Volume	To determine cerebellar volume, each T1 scan will be visually inspected to ensure inclusion of only minimal movement artifacts. All images will be processed in a blinded manner in order to maintain accuracy and consistency of volume calculation. Regional cerebellar volumes will be calculated using the SUIT toolbox of the SPM12 software.	Baseline, 6 months, 9 months, 12 months
Secondary	Timed Up and Go	The Timed Up and Go will be performed to assess balance. Participants will be asked to stand from seated and then walk around a cone that is 3 meters away. Participants will then walk back to the chair and sit back down. Participants will be timed.	Baseline, 6 months, 9 months, 12 months