Functional and Structural Imaging and Motor Control in Spinocerebellar Ataxia

NCT02488031 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-05-13

No results posted yet for this study

Summary

The purpose of this research study is to investigate how the brain and motor behavior changes both in individuals with spinocerebellar ataxia and healthy individuals, and to assess whether a therapeutic intervention reduces levels of uncoordinated movement and improves motor function in spinocerebellar ataxia (SCA).

Conditions

  • Spinocerebellar Ataxia

Interventions

BEHAVIORAL

Error-reduction

During this time participants will use a novel, custom designed computer interface to perform goal-directed movements with each leg in a 3D virtual environment designed to emphasize accurate movements. Leg movement will be detected using the LeapMotion sensor and we will quantify time endpoint errors by comparing the timing of the foot trajectory and the required time to target. The error-reduction intervention will be a 4-week home-based program. Each participant will train 4 days a week for approximately 1 hours per day. Within a week, the task difficulty will increase by changing the presentation of the targets to be more unpredictable and by increasing movement speed.

BEHAVIORAL

International Cooperative Ataxia Rating Scale

The ICARS is an assessment of the ataxia severity. The ICARS score is the total sum of the sub scores on specific movements and ranges from 0 to 100, with a score of 100 being indicative of the most severely affected outcome.

BEHAVIORAL

Scale for the Assessment and Rating of Ataxia

The SARA is an assessment of the ataxia severity. The SARA score is the total sum of the sub scores on specific movements and ranges from 0 to 100, with a score of 100 being indicative of the most severely affected outcome.

BEHAVIORAL

Beck Depression Inventory, 2nd Ed

This is a 21 question self-report inventory for measuring severity of depression.

BEHAVIORAL

Stroop

This test measures selective attention and cognitive flexibility through reading aloud of color names or color of the print.

BEHAVIORAL

Purdue Pegboard

This test consists of a series of timed hand coordination and dexterity tasks.

BEHAVIORAL

Brief Test of Attention

A cognitive test assessing focus and attention.

BEHAVIORAL

6-minute Walk

This test consists on a timed 6-minute walk test to evaluate how much distance is covered.

BEHAVIORAL

Hand Grip Dynamometer

This tests measures hand grip strength.

BEHAVIORAL

Montreal Cognitive Assessment

This test is used to assess cognitive abilities.

BEHAVIORAL

Physical Performance Function

This test consists of a series of physical activities used to evaluate speed, coordination, and ease of movement.

BEHAVIORAL

Biomechanical Assessments of Dysmetria

Dysmetria will be assessed using a custom-made goal-directed movement protocol where participant perform unloaded limb movement tasks and attempt to reach a space-time target. During these task muscle activity is monitored using Electromyography (EMG) recording.

BEHAVIORAL

Neurophysiological assessment of brain activity

Neurophysiology will be assessed by monitoring brain activity using Task-based fMRI and motor unit pool activity using a specialized EMG system.

BEHAVIORAL

Biomechanical gait analysis

Participants will wear APDM's wireless sensors on the hands, legs, trunk and forehead and walk overground a distance of 7 m for 2 minutes. APDM quantifies 80 common biomechanical outcomes of gait (e.g. stride length variability).

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH
  • University of South Florida

    collaborator OTHER
  • University of Florida

    lead OTHER

Principal Investigators

  • Evangelos Christou, PhD · University of Florida

  • David Vaillancourt, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-01-17
Completion
2019-01-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02488031 on ClinicalTrials.gov