What side effects are associated with this type of intervention?

Treatments for Cerebellar Ataxia that involve mental imagery and neurofeedback are generally non-invasive and have minimal side effects. However, patients may experience mild discomfort or fatigue during sessions. In broader treatments for Cerebellar Ataxia, medications such as amantadine, levetiracetam, and topiramate can be used, which may cause side effects like dizziness, fatigue, and gastrointestinal issues. Physical therapy and rehabilitation exercises are also common and typically have few side effects, though they may cause temporary muscle soreness.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments for cerebellar ataxia that utilize neuroimaging methods and mental imagery to enhance motor function. Most treatments for cerebellar ataxia focus on managing symptoms and improving quality of life through physical therapy, occupational therapy, and medications to address specific symptoms such as tremors or muscle stiffness. Research is ongoing to explore innovative approaches, including the use of real-time fMRI neurofeedback and motor imagery, to potentially improve motor timing and precision in individuals with cerebellar ataxia.

What other types of research exist?

Promising novel alternatives to mental imagery for cerebellar ataxia patients include: 1) Neurofeedback using real-time fMRI to enhance motor timing and precision, 2) High-intensity multicomponent agility interventions, 3) Resistance training with instability, and 4) Advanced physiotherapy techniques such as treadmill training and balance training. These approaches aim to improve motor function and quality of life by targeting motor networks and enhancing physical capabilities.

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Neurofeedback for Cerebellar Ataxia

N/A

Waitlist Available

Led By Cherie Marvel, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of progressive, degenerative cerebellar ataxia by a movement disorder specialist (cerebellar ataxia of unknown etiology, and spinocerebellar ataxias with and without genetic confirmation)

18-100 years of age

Must not have

History of head injury that resulted in a loss of consciousness greater than 5 minutes and/or neurological sequelae

Clinical diagnosis of multiple system atrophy (MSA) or Friedrich's ataxia (FA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and at-home sessions (10 minutes/day), up to 23 days

Awards & highlights

No Placebo-Only Group

Summary

This trial uses brain scans and imagination exercises to help people with cerebellar ataxia improve their movement abilities. The goal is to strengthen the brain areas responsible for movement by imagining physical activities. This approach could reduce motor deficits and enhance the quality of life for those affected.

Who is the study for?

This trial is for right-handed adults aged 18-100 with a clinical diagnosis of progressive cerebellar ataxia. Participants should have at least an 8th-grade education and no severe medical or neurological disorders, psychiatric disorders, or conditions that prevent MRI use. They must not be pregnant and should have internet access for home therapy.

What is being tested?

The study tests if neurofeedback treatment using real-time fMRI and motor imagery can improve motor timing and precision in people with cerebellar ataxia. It aims to 'exercise' the brain's motor networks to reduce deficits caused by cerebellar atrophy.

What are the potential side effects?

Since this intervention involves non-invasive techniques like fMRI scanning and mental exercises, there are minimal expected side effects. However, some participants might experience discomfort from lying still during scans or fatigue from concentration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with progressive cerebellar ataxia by a specialist.

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I am between 18 and 100 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a head injury that made me unconscious for more than 5 minutes or caused lasting brain effects.

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I have been diagnosed with MSA or Friedrich's ataxia.

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I do not have severe or unstable illnesses like stroke or epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at-home sessions (10 minutes/day), up to 23 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and at-home sessions (10 minutes/day), up to 23 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at-home sessions (10 minutes/day), up to 23 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in at-home overt tapping accuracy as assessed by finger tapping to a flashing cue at 1Hz speed

Change in at-home overt tapping accuracy as assessed by finger tapping to a flashing cue at 4Hz speed

Change in overt tapping accuracy as assessed by finger tapping to a flashing cue at 1Hz speed

+1 more

Secondary study objectives

The correlation between MRI BOLD and finger tapping accuracy to a flashing cue at 1Hz as assessed by a correlation coefficient

The correlation between MRI BOLD and finger tapping accuracy to a flashing cue at 4Hz as assessed by a correlation coefficient

Magnetic Resonance Imaging

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Real time neurofeedback with taskExperimental Treatment1 Intervention

Participants will undergo a real-time fMRI scan during which two distinct tasks will be performed.

Group II: Overt tapping and/or motor imagery practiceExperimental Treatment1 Intervention

Participants will undergo an overt tapping task at baseline. Participants are assigned to a group where the participants will then perform respective motor and/or imagery tasks at home for 3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neurofeedback treatment

2014

N/A

~190

At-home therapy

2023

N/A

~40

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Cerebellar Ataxia that involve neuroimaging methods and mental imagery work by 'exercising' motor networks in the brain. These treatments use real-time functional MRI (fMRI) neurofeedback and motor imagery to enhance motor timing and precision. By visualizing and mentally practicing movements, patients can activate specific brain regions associated with motor control, thereby strengthening neural pathways and improving motor function. This approach is particularly important for Cerebellar Ataxia patients as it targets the underlying neural deficits, potentially reducing motor impairments and enhancing quality of life.