Spinocerebellar AtaxiaSCANCT02488031
Functional and Structural Imaging and Motor Control in Spinocerebellar Ataxia
A study testing Error-reduction, International Cooperative Ataxia Rating Scale and Scale for the Assessment and Rating of Ataxia in people with Spinocerebellar Ataxia, run by University of Florida at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Spinocerebellar Ataxia
- What is being tested?
- Error-reduction, International Cooperative Ataxia Rating Scale and Scale for the Assessment and Rating of Ataxia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 17 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dysmetria in Motor Function in SCA: Mechanisms and Rehabilitation
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).
Read the detailed description
Thirty individuals who have been diagnosed with either Spinocerebellar Ataxia - 1 (SCA1), Spinocerebellar Ataxia - 3 (SCA3), or Spinocerebellar Ataxia - 6 (SCA6) will be recruited for this study. Participants will be randomly assigned to a best medical management (BMM / control) group and an error-reduction group. All participants will visit the lab twice for testing one month apart. Participants in the control group will not train between the pre- and post-test time.
The error-reduction intervention will be a 4-week home-based program. Investigators will use a novel, custom designed computer interface. Participants will perform goal-directed movements with each leg to targets in a 3D virtual environment designed to emphasize accurate movements. The goal-directed leg movements (similar to leg press) will be performed seated and require hip, knee, and ankle joint control. Leg movement will be detected using the LeapMotion sensor (Leap Motion Inc. San Francisco, CA), a device that supports hand, and finger / tool motions as input, similar to a mouse, but requiring no contact. Spatial endpoint errors will be quantified in 3D space by comparing the endpoint location of the foot trajectory (extending from the big toe) and the virtual location of the target. Time endpoint errors will be quantified by comparing the timing of the foot trajectory and the required time to target.
The length of the intervention will be 4 weeks. Each participant will train 4 days a week for ~1 hour per day. Within a week the task difficulty will increase by changing the presentation of the target from a predictable to an unpredictable location, by increasing movement speed requirements and by changing target size. Targets will be made predictable by identifying them prior to the cue for movement onset (target turning green). Specifically, there will be a flashing dotted line around the target prior to the target turning green. Targets will be made unpredictable by not providing any indication of the target location prior to the target turning green. Movement speed will be quantified from the voluntary movement onset of the leg (no reaction time) to the movement end.The movement speed requirements will be increased within a week and participants will learn to execute faster movements from the feedback after each trial. The size of the target will be progressively reduced during the 4 weeks.
All individuals in the study will receive a pre- and post-test assessment using the International Cooperative Ataxia Rating Scale (ICARS) and the Scale for the Assessment and Rating of Ataxia (SARA). The individual sections of the ICARS (e.g. Kinetic section) and SARA will be quantified.
In addition, leg dysmetria will be quantified using a custom-made goal-directed movement protocol. Specifically, participants will perform unloaded ankle dorsiflexion movements and attempt to reach a space-time target. The primary outcomes will be position and time errors.
Biomechanics of overground walking in SCA will be monitored using the APDM mobility lab (APDM, Inc. Mobility Lab, Oregon, USA). Participants will wear APDM's wireless sensors on the hands, legs, trunk and forehead and walk overground a distance of 7 meters for 2 minutes. APDM quantifies 80 common biomechanical outcomes of gait (e.g. stride length variability).
The neurophysiology of SCA will be quantified with functional Magnetic Resonance Imaging (fMRI) and motor unit pool activity. Brain activity will be quantified with task-based fMRI using a 32-channel head coil. During fMRI force tasks, ankle dorsiflexion will be measured from the most affected lower limb using customized fiber optic sensors, as has been done in the past. Real-time feedback of force performance will be provided to the subject. During the rest blocks, subjects will fixate on a stationary target but do not produce force. During task blocks, subjects will complete 2 second pulse-hold contractions to 15% maximum voluntary contraction(MVC) of ankle dorsiflexion followed by 1 second of rest. There will be 10 pulses per block. The knee will be supported by a pillow to flex the knee so that the forces applied by the ankle do not cause head movement.
- Conditions
- Spinocerebellar Ataxia
- Being tested
- Error-reduction, International Cooperative Ataxia Rating Scale, Scale for the Assessment and Rating of Ataxia, Beck Depression Inventory, 2nd Ed, Stroop
- Keywords
- SCA, dysmetria
- Medical subject headings
- Spinocerebellar Ataxias, Heart Arrest, Cerebellar Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Error-reductionBehavioural
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.
International Cooperative Ataxia Rating ScaleBehavioural
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.
Scale for the Assessment and Rating of AtaxiaBehavioural
Also called SARA
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.
Beck Depression Inventory, 2nd EdBehavioural
This is a 21 question self-report inventory for measuring severity of depression.
StroopBehavioural
This test measures selective attention and cognitive flexibility through reading aloud of color names or color of the print.
Purdue PegboardBehavioural
This test consists of a series of timed hand coordination and dexterity tasks.
Brief Test of AttentionBehavioural
A cognitive test assessing focus and attention.
6-minute WalkBehavioural
This test consists on a timed 6-minute walk test to evaluate how much distance is covered.
Hand Grip DynamometerBehavioural
This tests measures hand grip strength.
Montreal Cognitive AssessmentBehavioural
This test is used to assess cognitive abilities.
Physical Performance FunctionBehavioural
This test consists of a series of physical activities used to evaluate speed, coordination, and ease of movement.
Biomechanical Assessments of DysmetriaBehavioural
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.
Neurophysiological assessment of brain activityBehavioural
Neurophysiology will be assessed by monitoring brain activity using Task-based fMRI and motor unit pool activity using a specialized EMG system.
Biomechanical gait analysisBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Error-reduction | Experimental | 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. Receives: 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 |
| Best Medical Management | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Location of the Movement Endpoint Relative to the Target in the Motor Task
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).
Measured: Change from Baseline to 1 month
Secondary outcomes (3)
International Cooperative Ataxia Rating Scale(ICARS) Assessment
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.
Measured: Change from Baseline to 1 month
Change in Motor Unit Discharge Rate Variability
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.
Measured: Change from Baseline to 1 month
Change in Blood-oxygen-level-dependent(BOLD) Activity of Motor Cortex
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.
Measured: Change from Baseline to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startMar 2016
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Spinocerebellar AtaxiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), University of South Florida
- Responsible party
- Sponsor
- Investigators
- Evangelos Christou, PhD, Principal investigator, University of FloridaDavid Vaillancourt, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488031
- Sponsor's protocol ID
- IRB201500202-N
- Other IDs
- R21NS094946
- Acronym
- SCA
- Status last verified
- May 2019
- First submitted
- 30 Jun 2015
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Manto MU. The wide spectrum of spinocerebellar ataxias (SCAs). Cerebellum. 2005;4(1):2-6. doi: 10.1080/14734220510007914.
PubMed 15895552Manto M. Mechanisms of human cerebellar dysmetria: experimental evidence and current conceptual bases. J Neuroeng Rehabil. 2009 Apr 13;6:10. doi: 10.1186/1743-0003-6-10.
PubMed 19364396Solodkin A, Gomez CM. Spinocerebellar ataxia type 6. Handb Clin Neurol. 2012;103:461-73. doi: 10.1016/B978-0-444-51892-7.00029-2.
PubMed 21827907Schmitz-Hubsch T, Tezenas du Montcel S, Baliko L, Boesch S, Bonato S, Fancellu R, Giunti P, Globas C, Kang JS, Kremer B, Mariotti C, Melegh B, Rakowicz M, Rola R, Romano S, Schols L, Szymanski S, van de Warrenburg BP, Zdzienicka E, Durr A, Klockgether T. Reliability and validity of the International Cooperative Ataxia Rating Scale: a study in 156 spinocerebellar ataxia patients. Mov Disord. 2006 May;21(5):699-704. doi: 10.1002/mds.20781.
PubMed 16450347Kawaguchi Y, Okamoto T, Taniwaki M, Aizawa M, Inoue M, Katayama S, Kawakami H, Nakamura S, Nishimura M, Akiguchi I, et al. CAG expansions in a novel gene for Machado-Joseph disease at chromosome 14q32.1. Nat Genet. 1994 Nov;8(3):221-8. doi: 10.1038/ng1194-221.
PubMed 7874163Reetz K, Costa AS, Mirzazade S, Lehmann A, Juzek A, Rakowicz M, Boguslawska R, Schols L, Linnemann C, Mariotti C, Grisoli M, Durr A, van de Warrenburg BP, Timmann D, Pandolfo M, Bauer P, Jacobi H, Hauser TK, Klockgether T, Schulz JB; axia Study Group Investigators. Genotype-specific patterns of atrophy progression are more sensitive than clinical decline in SCA1, SCA3 and SCA6. Brain. 2013 Mar;136(Pt 3):905-17. doi: 10.1093/brain/aws369. Epub 2013 Feb 18.
PubMed 23423669Pasternak O, Shenton ME, Westin CF. Estimation of extracellular volume from regularized multi-shell diffusion MRI. Med Image Comput Comput Assist Interv. 2012;15(Pt 2):305-12. doi: 10.1007/978-3-642-33418-4_38.
PubMed 23286062Pasternak O, Sochen N, Gur Y, Intrator N, Assaf Y. Free water elimination and mapping from diffusion MRI. Magn Reson Med. 2009 Sep;62(3):717-30. doi: 10.1002/mrm.22055.
PubMed 19623619De Luca CJ, Adam A, Wotiz R, Gilmore LD, Nawab SH. Decomposition of surface EMG signals. J Neurophysiol. 2006 Sep;96(3):1646-57. doi: 10.1152/jn.00009.2006.
PubMed 16899649Morton SM, Bastian AJ. Cerebellar control of balance and locomotion. Neuroscientist. 2004 Jun;10(3):247-59. doi: 10.1177/1073858404263517.
PubMed 15155063Haines DE, Manto MU. Clinical symptoms of cerebellar disease and their interpretation. Cerebellum. 2007;6(4):360-74. doi: 10.1080/14734220701798199. No abstract available.
PubMed 18041661Keller JL, Bastian AJ. A home balance exercise program improves walking in people with cerebellar ataxia. Neurorehabil Neural Repair. 2014 Oct;28(8):770-8. doi: 10.1177/1545968314522350. Epub 2014 Feb 13.
PubMed 24526707
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysmetria in Motor Function in SCA: Mechanisms and Rehabilitation
- ClinicalTrials.gov ID
- NCT02488031
- Acronym / sponsor ID
- SCA / IRB201500202-N
- Conditions
- Spinocerebellar Ataxia
- Keywords
- SCA, dysmetria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), University of South Florida
- Study start
- Mar 2016
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Thirty individuals who have been diagnosed with either Spinocerebellar Ataxia - 1 (SCA1), Spinocerebellar Ataxia - 3 (SCA3), or Spinocerebellar Ataxia - 6 (SCA6) will be recruited for this study. Participants will be randomly assigned to a best medical management (BMM / control) group and an error-reduction group. All participants will visit the lab twice for testing one month apart. Participants in the control group will not train between the pre- and post-test time.
The error-reduction intervention will be a 4-week home-based program. Investigators will use a novel, custom designed computer interface. Participants will perform goal-directed movements with each leg to targets in a 3D virtual environment designed to emphasize accurate movements. The goal-directed leg movements (similar to leg press) will be performed seated and require hip, knee, and ankle joint control. Leg movement will be detected using the LeapMotion sensor (Leap Motion Inc. San Francisco, CA), a device that supports hand, and finger / tool motions as input, similar to a mouse, but requiring no contact. Spatial endpoint errors will be quantified in 3D space by comparing the endpoint location of the foot trajectory (extending from the big toe) and the virtual location of the target. Time endpoint errors will be quantified by comparing the timing of the foot trajectory and the required time to target.
The length of the intervention will be 4 weeks. Each participant will train 4 days a week for ~1 hour per day. Within a week the task difficulty will increase by changing the presentation of the target from a predictable to an unpredictable location, by increasing movement speed requirements and by changing target size. Targets will be made predictable by identifying them prior to the cue for movement onset (target turning green). Specifically, there will be a flashing dotted line around the target prior to the target turning green. Targets will be made unpredictable by not providing any indication of the target location prior to the target turning green. Movement speed will be quantified from the voluntary movement onset of the leg (no reaction time) to the movement end.The movement speed requirements will be increased within a week and participants will learn to execute faster movements from the feedback after each trial. The size of the target will be progressively reduced during the 4 weeks.
All individuals in the study will receive a pre- and post-test assessment using the International Cooperative Ataxia Rating Scale (ICARS) and the Scale for the Assessment and Rating of Ataxia (SARA). The individual sections of the ICARS (e.g. Kinetic section) and SARA will be quantified.
In addition, leg dysmetria will be quantified using a custom-made goal-directed movement protocol. Specifically, participants will perform unloaded ankle dorsiflexion movements and attempt to reach a space-time target. The primary outcomes will be position and time errors.
Biomechanics of overground walking in SCA will be monitored using the APDM mobility lab (APDM, Inc. Mobility Lab, Oregon, USA). Participants will wear APDM's wireless sensors on the hands, legs, trunk and forehead and walk overground a distance of 7 meters for 2 minutes. APDM quantifies 80 common biomechanical outcomes of gait (e.g. stride length variability).
The neurophysiology of SCA will be quantified with functional Magnetic Resonance Imaging (fMRI) and motor unit pool activity. Brain activity will be quantified with task-based fMRI using a 32-channel head coil. During fMRI force tasks, ankle dorsiflexion will be measured from the most affected lower limb using customized fiber optic sensors, as has been done in the past. Real-time feedback of force performance will be provided to the subject. During the rest blocks, subjects will fixate on a stationary target but do not produce force. During task blocks, subjects will complete 2 second pulse-hold contractions to 15% maximum voluntary contraction(MVC) of ankle dorsiflexion followed by 1 second of rest. There will be 10 pulses per block. The knee will be supported by a pillow to flex the knee so that the forces applied by the ankle do not cause head movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Error-reduction | Experimental | 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 analysisThe 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. |
| Best Medical Management | Experimental | 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 analysisThe 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. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Error-reductionDuring 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. | Behavioural | Error-reduction |
| International Cooperative Ataxia Rating ScaleThe 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. | Behavioural | Best Medical Management, Error-reduction |
| Scale for the Assessment and Rating of AtaxiaAlso: SARAThe 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. | Behavioural | Best Medical Management, Error-reduction |
| Beck Depression Inventory, 2nd EdThis is a 21 question self-report inventory for measuring severity of depression. | Behavioural | Best Medical Management, Error-reduction |
| StroopThis test measures selective attention and cognitive flexibility through reading aloud of color names or color of the print. | Behavioural | Best Medical Management, Error-reduction |
| Purdue PegboardThis test consists of a series of timed hand coordination and dexterity tasks. | Behavioural | Best Medical Management, Error-reduction |
| Brief Test of AttentionA cognitive test assessing focus and attention. | Behavioural | Best Medical Management, Error-reduction |
| 6-minute WalkThis test consists on a timed 6-minute walk test to evaluate how much distance is covered. | Behavioural | Best Medical Management, Error-reduction |
| Hand Grip DynamometerThis tests measures hand grip strength. | Behavioural | Best Medical Management, Error-reduction |
| Montreal Cognitive AssessmentThis test is used to assess cognitive abilities. | Behavioural | Best Medical Management, Error-reduction |
| Physical Performance FunctionThis test consists of a series of physical activities used to evaluate speed, coordination, and ease of movement. | Behavioural | Best Medical Management, Error-reduction |
| Biomechanical Assessments of DysmetriaDysmetria 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. | Behavioural | Best Medical Management, Error-reduction |
| Neurophysiological assessment of brain activityNeurophysiology will be assessed by monitoring brain activity using Task-based fMRI and motor unit pool activity using a specialized EMG system. | Behavioural | Best Medical Management, Error-reduction |
| Biomechanical gait analysisParticipants 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). | Behavioural | Best Medical Management, Error-reduction |
Primary outcome
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).
3 secondary outcomes
International Cooperative Ataxia Rating Scale(ICARS) Assessment
Time frame: Change from Baseline to 1 month
Change in Motor Unit Discharge Rate Variability
Time frame: Change from Baseline to 1 month
Change in Blood-oxygen-level-dependent(BOLD) Activity of Motor Cortex
Time frame: Change from Baseline to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Background: PubMed 15895552Manto MU. The wide spectrum of spinocerebellar ataxias (SCAs). Cerebellum. 2005;4(1):2-6. doi: 10.1080/14734220510007914.
- Background: PubMed 19364396Manto M. Mechanisms of human cerebellar dysmetria: experimental evidence and current conceptual bases. J Neuroeng Rehabil. 2009 Apr 13;6:10. doi: 10.1186/1743-0003-6-10.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evangelos Christou, PhD principal investigator
University of Florida
David Vaillancourt, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Error-reduction, International Cooperative Ataxia Rating Scale and Scale for the Assessment and Rating of Ataxia in people with Spinocerebellar Ataxia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Location of the Movement Endpoint Relative to the Target in the Motor Task (time frame: Change from Baseline to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02488031, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.