Use of a New Smartphone Application to Determine Changes in Eyeblink Conditioning From Home Training in Individuals With Spinocerebellar Ataxia

NCT06177626 | Not Yet Recruiting DMC

• 1 other identifier: AAAV2412 (Aim 2 and 3)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Spinocerebellar ataxias 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. Aerobic training show promise as a treatment for these diseases, but it is unclear if training induces neuroplastic changes within the damaged cerebellum to enhance motor learning, or if improvements are primarily caused by changes in leg strength, fatigue, and endurance. It is crucial to understand how the training impacts the brain, and particularly the cerebellum, in order to determine the most effective training regimen. To examine the impact of aerobic exercise on the brain, this study proposes using eyeblink conditioning, a form of motor learning that is dependent on the cerebellum. This study will utilize BlinkLab, a newly developed smartphone application, that overcomes the typical barriers of testing eyeblink conditioning by allowing in-home assessments without the need for expensive equipment. The investigators hypothesize that: 1) individuals with spinocerebellar ataxia will have impaired eyeblink conditioning, and 2) aerobic exercise, but not balance training, will improve eyeblink conditioning in this population. If these hypotheses are found to be true, it would further support that aerobic exercise is able to enhance motor learning in individuals with cerebellar damage. In Aim 1, investigators will test eyeblink conditioning in individuals with ataxias and follow them over time to see if eyeblink conditioning might be a biomarker for cerebellar ataxia disease progression. The investigators will then use these preliminary results to devise a larger study to further validate eyeblink conditioning as a biomarker for ataxia disease progression. Aim 2 will determine the impact of training on eyeblink conditioning. The investigators expect that aerobic training, but not balance training, will enhance eyeblink conditioning in spinocerebellar ataxia. Finally, Aim 3 will explore the use of eyeblink conditioning as a biomarker of neuroplasticity.

Conditions

Spinocerebellar Ataxias

Keywords

Ataxia; Eyeblink Conditioning; Exercise

Outcome Measures

Primary Outcomes (1)

• Conditioned Response (CR) Amplitude

  Individual eyelid traces will be normalized by dividing each trace by the maximum signal amplitude of the relevant session. Thus, eyes closed will correspond to a value of 1, and eyes open to a value of 0. A mean baseline Conditioned Response (CR) amplitude will be determined for each participant using the pre-block Conditioned Stimulus (CS) only trials. CR amplitude will then be determined as the maximum signal amplitude value at 430ms, for paired and CS only trials, minus the baseline CR amplitude.

  0, 3, and 4 months

Secondary Outcomes (7)

• Scale for the Assessment and Rating of Ataxia (SARA)

  0, 3, and 4 months

• PROM of Ataxia Score

  0, 3, and 4 months

• Quantitative Muscle Testing (QMT)

  0, 3, and 4 months

• 6-minute Walk Test (6MWT)

  0, 3, and 4 months

• Balance Measures

  0, 3, and 4 months

Study Arms (2)

Balance Training

ACTIVE COMPARATOR

A physical therapist will tailor a home balance training program for each participant based on pre- training capabilities. Participants 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.

Behavioral: Balance Training

Aerobic Training

EXPERIMENTAL

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. Participants will record duration of exercise, perceived exertion, average heart rate, maximum heart rate, and distance.

Behavioral: Aerobic Training

Interventions

Aerobic Training BEHAVIORAL

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

Aerobic Training

Balance Training BEHAVIORAL

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

Balance Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with spinocerebellar ataxia
• Cerebellar atrophy on MRI
• Prevalence of ataxia on clinical exam (SARA \>2)
• Ability to safely ride a stationary exercise bike (SARA sitting sub-score \<3)

You may not qualify if:

• Parkinson's Disease
• Traumatic Brain Injury
• Stroke
• Alzheimer's Disease
• Heart disease
• Dementia
• Medical instability
• Inability to walk without assistance (SARA gait sub-score \>6).

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University/New York Presbyterian

New York, New York, 10035, United States

Location

MeSH Terms

Conditions

Spinocerebellar Ataxias; Ataxia; Motor Activity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Scott Barbuto, MD, PhD

CONTACT

212-305-3535; sb3779@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Rehabilitation and Regenerative Medicine

Model Details: Single blinded randomized controlled trial

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)