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Training in Ataxia - Individuals With Degenerative Cerebellar Diseases

Primary Purpose

Cerebellar Ataxia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Training
Balance Training
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebellar Ataxia focused on measuring ataxia, cerebellar ataxia, exercise, training, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Irving Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic Training

Balance Training

Arm Description

Participants will be given a stationary exercise bike for home use. They will be instructed to use the exercise bike five times a week for thirty-minute sessions. The exercise intensity prescription will be based on the subject's VO2max determined on pre-test day. The exercise program will start at 60% of intensity per session, and then will be increased by steps of 5% intensity every 2 sessions until participants reach 30 minutes of training at 80% intensity. Participants will be contacted weekly by e-mail or phone to answer any questions about the exercise protocol and will be instructed to log each training session. Subjects will record duration of exercise, perceived exertion, average heart rate, maximum heart rate, and distance.

A physical therapist will tailor a home balance training program for each participant based on pre- training capabilities. Subjects will be asked to perform exercises five times a week for thirty-minute sessions. Both dynamic and static exercises will be performed in sitting and standing positions. Exercises will start with stabilizing in a challenging static position and progress to dynamic arm and leg movements in the same or modified position. Participants will be contacted weekly by e-mail or phone to answer any questions about the exercise protocol and will be required to log their exercise effort in terms of frequency and level of balance challenge.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 4, 2021
Last Updated
February 7, 2023
Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT05002218
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebellar Ataxia
Keywords
ataxia, cerebellar ataxia, exercise, training, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a single-blinded randomized control trial.
Masking
Care ProviderOutcomes Assessor
Masking Description
Care providers and outcome assessor will not know which group individuals are assigned. In addition, the primary outcome will be video-recorded and the videos will be scrambled so that outcome assessor will not know if the test was done pre- or post-training.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Training
Arm Type
Experimental
Arm Description
Participants will be given a stationary exercise bike for home use. They will be instructed to use the exercise bike five times a week for thirty-minute sessions. The exercise intensity prescription will be based on the subject's VO2max determined on pre-test day. The exercise program will start at 60% of intensity per session, and then will be increased by steps of 5% intensity every 2 sessions until participants reach 30 minutes of training at 80% intensity. Participants will be contacted weekly by e-mail or phone to answer any questions about the exercise protocol and will be instructed to log each training session. Subjects will record duration of exercise, perceived exertion, average heart rate, maximum heart rate, and distance.
Arm Title
Balance Training
Arm Type
Active Comparator
Arm Description
A physical therapist will tailor a home balance training program for each participant based on pre- training capabilities. Subjects will be asked to perform exercises five times a week for thirty-minute sessions. Both dynamic and static exercises will be performed in sitting and standing positions. Exercises will start with stabilizing in a challenging static position and progress to dynamic arm and leg movements in the same or modified position. Participants will be contacted weekly by e-mail or phone to answer any questions about the exercise protocol and will be required to log their exercise effort in terms of frequency and level of balance challenge.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Training
Intervention Description
Aerobic training on stationary bike 5x a week for 30 minutes a day.
Intervention Type
Behavioral
Intervention Name(s)
Balance Training
Intervention Description
Balance training 5x a week for 30 minutes as instructed by a therapist. Standard of care.
Primary Outcome Measure Information:
Title
Change in Assessment and Rating of Ataxia (SARA) Score
Description
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.
Time Frame
Baseline, 6 months, 9 months, 12 months
Secondary Outcome Measure Information:
Title
Average gait speed
Description
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.
Time Frame
Baseline, 6 months, 9 months, 12 months
Title
Dynamic Gait Index score
Description
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.
Time Frame
Baseline, 6 months, 9 months, 12 months
Title
Prevalence of desired changes in Diffuse Tensor Imaging
Description
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.
Time Frame
6 months
Title
Prevalence of desired changes in Resting State fMRI scans
Description
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.
Time Frame
6 months
Title
Prevalence of Cerebellar Volume
Description
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.
Time Frame
Baseline, 6 months, 9 months, 12 months
Title
Timed Up and Go
Description
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.
Time Frame
Baseline, 6 months, 9 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Barbuto, MD
Phone
518-275-9588
Email
sb3779@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott M Barbuto, MD
Organizational Affiliation
Assistant Professor of Rehabilitation and Regenerative Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott M Barbuto, MD
Phone
212-305-3535
Email
sb3779@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Scott Barbuto

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Training in Ataxia - Individuals With Degenerative Cerebellar Diseases

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