What side effects are associated with this type of intervention?

Behavioral reinforcement training paradigms for Cerebellar Ataxia typically have minimal side effects, mainly involving fatigue or temporary discomfort from repetitive practice. Other common treatments include physical and occupational therapy, which are generally safe but can cause fatigue. Medications like amantadine or buspirone may lead to dizziness, nausea, and fatigue. Surgical options such as deep brain stimulation (DBS) carry more significant risks, including infection, bleeding, and hardware complications.

What prior FDA approvals exist?

The provided context does not mention specific FDA-approved drugs for the treatment of Cerebellar Ataxia. However, the study on reinforcement-based training paradigms suggests a focus on behavioral interventions to improve motor function. This approach is distinct from pharmacological treatments and aligns more with physical therapy and rehabilitation strategies aimed at enhancing motor skills through practice and reinforcement.

What other types of research exist?

Promising novel alternatives for treating Cerebellar Ataxia in 2024 include: 1) Video game-based coordinative training, which has shown improvements in ataxia symptoms in children using Xbox Kinect games. 2) Transcranial Direct Current Stimulation (tDCS), which has been effective in improving motor function in various neurological conditions. 3) Pharmacological interventions such as Gabapentin and Levetiracetam, which have shown efficacy in treating chorea and other movement disorders associated with ataxia.

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Behavioral Intervention

Visual Feedback Reach Training for Ataxia

N/A

Recruiting

Led By Amy J Bastian, PhD, PT

Research Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Eligibility Criteria Checklist

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

Must have

Age 22-80

Cerebellar damage from stroke, tumor or degeneration

Must not have

Vision loss that interferes with the tasks

Pain that interferes with the tasks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed every study visit week 1 to week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two training methods to improve arm movements in people with cerebellar ataxia. It targets individuals who struggle with movement coordination due to cerebellum damage. The methods involve practicing reaching movements with feedback to enhance coordination.

Who is the study for?

This trial is for individuals aged 22-80 with cerebellar ataxia due to stroke, tumor, or degeneration. It's not suitable for those with extrapyramidal symptoms, vestibular loss, sensory neuropathy, significant pain or dementia (Mini-Mental State exam score > 22), vision loss affecting task performance, or damage to brain areas outside the cerebellum.

What is being tested?

The study tests a reinforcement-based training method against standard practices over several weeks to improve reaching movements in people with ataxia. Participants will receive reach training that includes visual feedback.

What are the potential side effects?

Since this intervention involves physical therapy techniques and not medication, side effects are minimal but may include muscle soreness or fatigue from the exercises.

Eligibility Criteria

Inclusion Criteria

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

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I am between 22 and 80 years old.

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I have damage to my cerebellum due to stroke, tumor, or degeneration.

Exclusion Criteria

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

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My vision loss affects my daily activities.

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My pain stops me from doing daily tasks.

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I have movement disorders, balance issues, or numbness in my limbs.

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I have brain damage beyond the cerebellum, confirmed by clinical assessment or MRI.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every study visit week 1 to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed every study visit week 1 to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every study visit week 1 to week 12 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Hand path distance during natural reaching to the trained target locations.

Secondary study objectives

ARAT ( Action Research Arm Test)

ICARS (International Cooperative Ataxia Rating Scale)

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: Standard Practice TrainingExperimental Treatment1 Intervention

Reach training with visual feedback. During each training session, participants will first be familiarized with the task and then will reach from a home position to 4 virtual targets that are presented in the front of the participant and within the workspace where most natural arm movements are performed. During training the participant will reach a total of 400 times. For standard practice, participants will be able to see a cursor that represents the position of the hand at all times and try to make straight reaches to the targets. This type of feedback provided specific information about the location of the hand.

Group II: Reinforcement TrainingExperimental Treatment1 Intervention

Reach training with visual feedback. During each training session, participants will first be familiarized with the task and then will reach from a home position to 4 virtual targets that are presented in the front of the participant and within the workspace where most natural arm movements are performed. During training the participant will reach a total of 400 times. For reinforcement training, participants will not see their hand or a cursor, but instead participants will receive target-specific binary feedback after each reach (i.e. based on running average of last 10 reaches to that target). Binary feedback indicates only whether the reach was successful or unsuccessful and provides no specific information about the location of the hand.

0 / 6Eligibility 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, particularly those similar to the reinforcement-based training paradigm, focus on improving motor function through repetitive practice and positive reinforcement. This method aims to retrain the brain by encouraging correct movements and gradually enhancing coordination. For Cerebellar Ataxia patients, whose condition involves impaired coordination due to cerebellar dysfunction, such targeted exercises can help improve motor skills and reduce symptoms, thereby enhancing their overall quality of life.