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Functional and Structural Imaging and Motor Control in Spinocerebellar Ataxia (SCA)

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ClinicalTrials.gov Identifier: NCT02488031
Recruitment Status : Completed
First Posted : July 2, 2015
Last Update Posted : May 13, 2019
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of South Florida
Information provided by (Responsible Party):
University of Florida

Brief 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).

Condition or disease Intervention/treatment Phase
Spinocerebellar Ataxia Behavioral: Error-reduction Behavioral: International Cooperative Ataxia Rating Scale Behavioral: Scale for the Assessment and Rating of Ataxia Behavioral: Beck Depression Inventory, 2nd Ed Behavioral: Stroop Behavioral: Purdue Pegboard Behavioral: Brief Test of Attention Behavioral: 6-minute Walk Behavioral: Hand Grip Dynamometer Behavioral: Montreal Cognitive Assessment Behavioral: Physical Performance Function Behavioral: Biomechanical Assessments of Dysmetria Behavioral: Neurophysiological assessment of brain activity Behavioral: Biomechanical gait analysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dysmetria in Motor Function in SCA: Mechanisms and Rehabilitation
Study Start Date : March 2016
Actual Primary Completion Date : January 17, 2019
Actual Study Completion Date : January 17, 2019


Arm Intervention/treatment
Experimental: Error-reduction
The participants in the error-reduction group will participate in a 4-week home-based training intervention during the month between their pre- and post-test visits. During pre- and post- training visits, Cooperative Ataxia Rating Scale (ICARS) and the Scale for the Assessment and Rating of Ataxia (SARA), Purdue Pegboard, Brief Test of Attention, 6-minute Walk, Hand Grip Dynamometer, Physical Performance Function, Digit Span, SARA, Montreal Cognitive Assessment, Beck Depression Inventory 2nd Ed, Stroop and biomechanical gait analysis tests will be administered. Also biomechanical assessments of dysmetria and neurophysiological assessment of brain activity will be conducted to evaluate the impact of the training on SCA individuals.
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.
Other Name: SARA

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).

Experimental: Best Medical Management
The participants in the best medical management group will undergo identical testing sessions (two visits one month apart) as those in the error-reducing group but will not receive the 4-week error reducing intervention. They will be administered the International Cooperative Ataxia Rating Scale (ICARS) and the Scale for the Assessment and Rating of Ataxia (SARA) assessments and the following tests: Purdue Pegboard, Brief Test of Attention, 6-minute Walk, Hand Grip Dynamometer, Physical Performance Function, Digit Span, SARA, Montreal Cognitive Assessment, Beck Depression Inventory 2nd Ed, Stroop and biomechanical gait. Biomechanical assessments of dysmetria and neurophysiological assessment of brain activity will be conducted at both visits.
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.
Other Name: SARA

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).




Primary Outcome Measures :
  1. Change in the Location of the Movement Endpoint Relative to the Target in the Motor Task [ Time Frame: Change from Baseline to 1 month ]
    Assessment of the subject's ability to stay on target during the motor task. The task is a goal-directed movement that aims to match a spatial target in a specific time(time target).


Secondary Outcome Measures :
  1. International Cooperative Ataxia Rating Scale(ICARS) Assessment [ Time Frame: Change from Baseline to 1 month ]
    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.

  2. Change in Motor Unit Discharge Rate Variability [ Time Frame: Change from Baseline to 1 month ]
    Amount of motor unit activity occurring during the Electromyography(EMG) task. Lower amount of variability is better. The change reflects the difference in values between the pre- and post-training sessions. The discharge rate variability will change by percent.

  3. Change in Blood-oxygen-level-dependent(BOLD) Activity of Motor Cortex [ Time Frame: Change from Baseline to 1 month ]
    Results of blood-oxygen-level-dependent contrast imaging as analyzed from functional Magnetic Resonance Imaging(fMRI). More colors indicates more excitement of the motor cortex.



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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DNA diagnosis of SCA1, SCA3, or SCA6
  • phenotype consistent with the DNA diagnosis
  • ability to walk 7 meters
  • the age of 21-85 years
  • capable of providing informed consent and complying with the trial procedures

Exclusion Criteria:

  • Known recessive, X-linked or mitochondrial ataxias or any other type of ataxia
  • Concomitant disorder(s) that affect ataxia measures used in this study
  • Cognitive status on the Montreal Cognitive Assessment < 24
  • Patients who have any type of implanted electrical device (such as a cardiac pacemaker or a neurostimulator), or a certain type of metallic clip in their body (i.e., an aneurysm clip in the brain), and are not eligible for participation in the MRI portion of the study
  • Individuals who are claustrophobic
  • Women who are or might be pregnant and nursing mothers
  • Individuals with psychiatric disorders or dementia, along with other neurological and orthopedic problems that impair hand movements and walking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488031


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Institute of Neurological Disorders and Stroke (NINDS)
University of South Florida
Investigators
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Principal Investigator: Evangelos Christou, PhD University of Florida
Principal Investigator: David Vaillancourt, PhD University of Florida
Publications:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02488031    
Other Study ID Numbers: IRB201500202-N
R21NS094946 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Florida:
SCA, dysmetria
Additional relevant MeSH terms:
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Ataxia
Spinocerebellar Ataxias
Spinocerebellar Degenerations
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Cerebellar Ataxia
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn