Retraining Reaching in Cerebellar Ataxia

Cerebellar Ataxia Clinical Trial

Official title:

Retraining Reaching in Cerebellar Ataxia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03879018
• Other study ID #: IRB00182673
• Secondary ID: 2R01HD040289-15A
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: May 1, 2026

Study information

• Verified date: May 2024
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: Anthony J Gonzalez, BS
• Phone: 4439232716
• Email: agonza30[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test for benefits of reinforcement based training paradigm versus standard practice over weeks for improving reaching movements in people with ataxia.

Description:

Damage to the cerebellum produces characteristic deficits in movement coordination, known as "ataxia." Reaching movements become curved, tremulous, and over- or undershoot targets, thus affecting nearly all activities of daily living. Sitting and standing balance becomes unsteady, and walking has a characteristic 'drunken' appearance with lateral veering and a widening of the base of support. People with many types of neurological diseases (e.g. autosomal dominant ataxias (e.g. SCAs), multiple sclerosis, cerebral palsy, stroke, Freidreich's ataxia) often have disabling ataxia.

In past work the investigators have shown that many individuals with ataxia from cerebellar disease can learn simple visuomotor tasks using reinforcement learning paradigms. The investigators do not know if individuals with ataxia from cerebellar disease can improve more complex motor patterns. In general, there are few rehabilitation studies on ataxia, with most focusing on balance and walking. Yet, arm ataxia is a significant problem that affects most all activities of daily living (e.g. eating, cooking, bathing, dressing, working). Many studies have assessed reaching ataxia on single days in order to try to better understand the fundamental basis for ataxic arm movements. Based on previous literary searches, there are only a couple of small studies that have tested whether training over weeks can mitigate arm ataxia. Each of these was a case series of either 3 or 4 people, and all patients had ataxia from lesions that included structures outside of the cerebellum. Both showed some positive effects but responses varied across patients. This work that the investigators propose will look at the affects of a longer training regimen of upper limb reaching in people with cerebellar ataxia.

The investigators will study cerebellar patients that have shown the ability to learn from previous work. Subjects with cerebellar ataxia will be randomized into two groups to receive either reinforcement training or standard practice training over a 12 week period. Subjects will train for 45 minutes a day, 3 times per week for two weeks for each type of training, with a two week 'rest' period in between. After training, subjects will be asked to return for two visits to test for retention. On each training day, reinforcement training (or standard practice) will be done using an Oculus Rift and Touch 3D headset. Training encompasses reaching to a 3D target with either online visual feedback or binary feedback 400 times. Motion tracking sensors will be placed on the shoulder, elbow, wrist, and finger, in order to track movement data in real time. These studies will provide important new information about upper limb long term training with visual feedback in individuals with Cerebellar Ataxia

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: May 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

Inclusion Criteria:

• Cerebellar damage from stroke, tumor or degeneration

• Age 22-80

Exclusion Criteria:

• Clinical or MRI evidence of damage to extracerebellar brain (e.g. multiple system atrophy)

• Extrapyramidal symptoms, peripheral vestibular loss, or sensory neuropathy

• Dementia ( Mini-Mental State exam > 22)

• Pain that interferes with the tasks

• Vision loss that interferes with the tasks

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia

Intervention

Behavioral:
• Reach training with visual feedback
Reach training will be accomplished using an Oculus Rift and Touch 3D headset. Active markers will be placed on the shoulder, elbow, wrist, and finger in order to capture limb movement in real time. 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.Targets will be presented in a pseudorandom order and participants will reach a total of 400 times

Locations

Country	Name	City	State
United States	Motion Analysis Lab in the Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hand path distance during natural reaching to the trained target locations.	Hand path distance is the percent above an ideal (straight reach) averaged over reaches to all 4 targets. To collect this measure, investigators will use motion capture equipment to record the positions of active markers that subjects will wear on their shoulder, elbow, wrist, and finger.	Assessed every study visit week 1 to week 12
Secondary	ICARS (International Cooperative Ataxia Rating Scale)	ICARS is a standardized scale used to quantify the level of impairment in people with cerebellar ataxia. The ICARS is a 0- 100 point scale system with four subscales that include, postural and gait disturbances, limb ataxia, dysarthria, and Oculomotor disorders. Postural and gait disturbances are scaled 0 to 34 points. Limb ataxia is scaled 0 to 52 points. Dysarthria is scaled 0 to 8 points, and Oculomotor disorders is scaled 0 to 6 points. The higher the score indicates greater impairment.	Assessed week 1 before the first training session, and week 12
Secondary	ARAT ( Action Research Arm Test)	The ARAT is an assessment used to measure changes in upper limb function in people who have experienced damage or disease to the nervous system (e.g., multiple sclerosis, stroke, Parkinson's disease, cerebellar ataxia).	Assessed week 1 before the first training session, and week 12