Spinocerebellar Ataxia (SCA)NCT06363058
Electrical Stimulation Cycling Training Effects on SCA
A study testing ES Cycling Training in people with Spinocerebellar Ataxia (SCA), run by Chang Gung University at 1 site in Taiwan.
Trial summary
To focuses on the challenges faced by individuals with spinocerebellar ataxia (SCA), highlighting the major clinical sign of ataxia that affects their stability and ability to perform daily activities, thereby impacting their quality of life. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinocerebellar Ataxia (SCA)
- What is being tested?
- ES Cycling Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2022to 31 Jul 2025
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of SCA.
Who cannot join
- Musculoskeletal injuries on legs.
- Osteoporosis.
- SCA subjects:
- Musculoskeletal injuries on legs
- Osteoporosis.
- Any peripheral or central nervous system injury or disease patients.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung University
Taoyuan, 333
Ya-Ju Chang, PhD, 88632118800 ext. 5515, yjchang@mail.cgu.edu.tw
About this study
Official title: Effect of Combined ES Cycling Training on Individuals With SCA
To focuses on the challenges faced by individuals with spinocerebellar ataxia (SCA), highlighting the major clinical sign of ataxia that affects their stability and ability to perform daily activities, thereby impacting their quality of life. It outlines the concept of neural plasticity, which is the brain's ability to adapt through changes in excitability, and notes that these changes are more enduring in the central nervous system (CNS) than in the peripheral nervous system (PNS). This adaptability, crucial for memory and motor learning, is compromised in SCA patients due to impaired brain areas and pathways. The summary further delves into motor learning, distinguishing between explicit and implicit learning, and points out that SCA patients exhibit deficiencies in procedural learning and cerebellar function. It also introduces the concept of priming as a preparatory mechanism that can enhance the effectiveness of physical therapy by modifying subsequent responses to stimuli. The document suggests that cycling, as an aerobic exercise, could prime the brain for improved blood flow and oxygenation, thereby supporting synaptic plasticity and the release of beneficial neurotrophic factors. Finally, the project aims to deepen the understanding of motor performance and learning mechanisms in SCA patients and apply these insights to clinical rehabilitation strategies.
Read the detailed description
Ataxia is the major clinical sign of spinocerebellar ataxia (SCA) patients. Increased postural sway and instability during volitional movements appear and hinder SCA patients from performing normal daily life activities and influence quality of life of victims.
Neural plasticity comes from excitability changes. Changes in excitability produced by repetitive activities at synapses maintain a longer time in the central nervous system (CNS) than the changes in the peripheral nervous system (PNS). The long duration of synaptic excitability changes may be linked to memory and motor learning. Neural plasticity could be investigated by several non-invasive instruments, such as Transcranial Magnetic Stimulation (TMS). The excitability is suppressed in SCA patients due to corrupted brain areas and pathways.
Motor learning is the process of obtaining the capability for movement. Motor learning is not merely focusing on changes in performance during practice but also being evaluated during retention and/or transfer. Motor learning can be divided into explicit and implicit learning. One type of implicit learning is the acquisition of motor skills, often referred to as procedural learning. Serial reaction time task (SRTT) is used to describe implicit sequence motor learning. A series of implicit motor sequence learning tasks is to clarify the role and function of the cerebellum. And this function is deficient in SCA patients.
Priming is an unconscious process associated with learning to alter the later response by the proceeding stimulus. Priming is applied to physical therapy; it could result in behavioral change and strengthen the training effect afterward.
Cycling could be an aerobic exercise priming that may help to raise brain blood flow and oxygenation, facilitate synaptic plasticity, augment the release of neurotrophic factors, to transmit neuroendocrine and myokines.
This project will advance the knowledge of the mechanism of motor performance and motor learning in SCA individuals. The result of this project can be applied to the clinical rehabilitation of people with SCA.
- Conditions
- Spinocerebellar Ataxia (SCA)
- Being tested
- ES Cycling Training
- Keywords
- Motor Control, Motor Learning, Priming, Excitability
- Medical subject headings
- Spinocerebellar Ataxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ES Cycling TrainingOther
Implementing Electrical Stimulation (ES) Cycling combined with priming strategies to enhance motor learning tasks
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Healthy people | No intervention | To establish a baseline and ensure reliability, and to develop a training protocol for stage 3. |
| Stage 2: Short-term training SCA people | Experimental | Short-term ES Cycling Training Receives: Other: ES Cycling Training |
| Stage 2: SCA Control group | No intervention | Control Group |
| Stage 3:Long-term training SCA people | Experimental | Long-term ES Cycling Training Receives: Other: ES Cycling Training |
| Stage 3: SCA Control group | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Time
The sum of reaction time and movement time, providing a complete measure of the time taken from the stimulus presentation to the completion of the response. Unit: Second(s)
Measured: Baseline, 2 weeks and 4 weeks
Overall Error Rate
The total proportion of incorrect responses across a testing session or series of tasks.
Measured: Baseline, 2 weeks and 4 weeks
Motor Evoked Potentials (MEPs)
MEPs are the electrical responses recorded from muscles following stimulation of the motor cortex. They reflect the efficiency of neural transmission from the cortex to the muscle. Unit: millivolts (mV).
Measured: Baseline, 2 weeks and 4 weeks
Intracortical Facilitation (ICF)
ICF is measured by applying a pair of TMS pulses with a short interval (e.g., 8-15 ms) where the first (subthreshold) pulse is followed by a second (suprathreshold) pulse, leading to an increased amplitude of the MEP.
Measured: Baseline, 2 weeks, and 4 weeks.
Intracortical Inhibition (ICI)
ICI is measured similarly to ICF but with a shorter inter-stimulus interval (e.g., 1-5 ms), resulting in a suppressed MEP amplitude. This suppression reflects inhibitory processes within the cortex.
Measured: Baseline, 2 weeks, and 4 weeks.
Total Scale for the Assessment and Rating of Ataxia (SARA) Score
To objectively assess ataxia severity across various domains of motor function including gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movements, and heel-shin slide. Each item is scored individually with a scale that typically ranges from 0 (no ataxia) to a maximum score that depends on the severity and the aspect of ataxia being assessed. The total score ranges from 0 (no ataxia) to 40 (most severe ataxia).
Measured: Baseline, 2 weeks, and 4 weeks.
Total Berg Balance Scale (BBS) Score
To measure an individual's balance abilities through various tasks that mimic daily activities, assessing the risk of falls and overall balance proficiency. The BBS consists of 14 items that evaluate a range of functions including sitting to standing, standing unsupported, transferring, turning to look behind, picking up an object from the floor, and standing on one leg. Each task is rated on a scale from 0 (unable) to 4 (independent), with the total score ranging from 0 to 56. A higher total score indicates better balance and lower fall risk. Scores below 45 are generally indicative of increased fall risk.
Measured: Baseline, 2 weeks, and 4 weeks.
Total Time to Complete the Time Up and Go test (TUG test)
The time, in seconds, it takes for a participant to complete the TUG test from the initial sitting position to returning to the seated position. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.
Measured: Baseline, 2 weeks, and 4 weeks.
Walking Speed
The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).
Measured: Baseline, 2 weeks, and 4 weeks.
Step Length
The linear distance between the two ankles, typically expressed in centimeter(cm).
Measured: Baseline, 2 weeks, and 4 weeks.
Step Time
The duration taken for one complete step, measuring from foot-off of one foot to the next foot-off of the same foot, usually expressed in seconds.
Measured: Baseline, 2 weeks, and 4 weeks.
Secondary outcomes (5)
Double Support Time
The portion of the gait cycle where both feet are in contact with the ground, indicating the transition phase between steps, expressed as a percentage of the gait cycle or in seconds.
Measured: Baseline, 2 weeks, and 4 weeks.
Single Support Time
The duration within the gait cycle when only one foot is in contact with the ground, typically measured in seconds or as a percentage of the total gait cycle
Measured: Baseline, 2 weeks, and 4 weeks.
Swing Time
The portion of the gait cycle where the foot is not in contact with the ground, moving forward to the next step. It is usually expressed as a percentage of the total gait cycle or in seconds.
Measured: Baseline, 2 weeks, and 4 weeks.
Stance Time
The portion of the gait cycle when the foot is in contact with the ground, supporting body weight. It's typically expressed as a percentage of the total gait cycle or in seconds
Measured: Baseline, 2 weeks, and 4 weeks.
Cadence
The number of steps an individual takes per minute, providing an overview of gait speed and rhythm, , expressed as steps per minute.
Measured: Baseline, 2 weeks, and 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start8 Apr 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinocerebellar Ataxia (SCA)Studies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Ju Chang, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363058
- Sponsor's protocol ID
- 201902166B0
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined ES Cycling Training on Individuals With SCA
- ClinicalTrials.gov ID
- NCT06363058
- Acronym / sponsor ID
- 201902166B0
- Conditions
- Spinocerebellar Ataxia (SCA)
- Keywords
- Motor Control, Motor Learning, Priming, Excitability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 12 Apr 2024 (actual)
- 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.
To focuses on the challenges faced by individuals with spinocerebellar ataxia (SCA), highlighting the major clinical sign of ataxia that affects their stability and ability to perform daily activities, thereby impacting their quality of life. It outlines the concept of neural plasticity, which is the brain's ability to adapt through changes in excitability, and notes that these changes are more enduring in the central nervous system (CNS) than in the peripheral nervous system (PNS). This adaptability, crucial for memory and motor learning, is compromised in SCA patients due to impaired brain areas and pathways. The summary further delves into motor learning, distinguishing between explicit and implicit learning, and points out that SCA patients exhibit deficiencies in procedural learning and cerebellar function. It also introduces the concept of priming as a preparatory mechanism that can enhance the effectiveness of physical therapy by modifying subsequent responses to stimuli. The document suggests that cycling, as an aerobic exercise, could prime the brain for improved blood flow and oxygenation, thereby supporting synaptic plasticity and the release of beneficial neurotrophic factors. Finally, the project aims to deepen the understanding of motor performance and learning mechanisms in SCA patients and apply these insights to clinical rehabilitation strategies.
Detailed description
Ataxia is the major clinical sign of spinocerebellar ataxia (SCA) patients. Increased postural sway and instability during volitional movements appear and hinder SCA patients from performing normal daily life activities and influence quality of life of victims.
Neural plasticity comes from excitability changes. Changes in excitability produced by repetitive activities at synapses maintain a longer time in the central nervous system (CNS) than the changes in the peripheral nervous system (PNS). The long duration of synaptic excitability changes may be linked to memory and motor learning. Neural plasticity could be investigated by several non-invasive instruments, such as Transcranial Magnetic Stimulation (TMS). The excitability is suppressed in SCA patients due to corrupted brain areas and pathways.
Motor learning is the process of obtaining the capability for movement. Motor learning is not merely focusing on changes in performance during practice but also being evaluated during retention and/or transfer. Motor learning can be divided into explicit and implicit learning. One type of implicit learning is the acquisition of motor skills, often referred to as procedural learning. Serial reaction time task (SRTT) is used to describe implicit sequence motor learning. A series of implicit motor sequence learning tasks is to clarify the role and function of the cerebellum. And this function is deficient in SCA patients.
Priming is an unconscious process associated with learning to alter the later response by the proceeding stimulus. Priming is applied to physical therapy; it could result in behavioral change and strengthen the training effect afterward.
Cycling could be an aerobic exercise priming that may help to raise brain blood flow and oxygenation, facilitate synaptic plasticity, augment the release of neurotrophic factors, to transmit neuroendocrine and myokines.
This project will advance the knowledge of the mechanism of motor performance and motor learning in SCA individuals. The result of this project can be applied to the clinical rehabilitation of people with SCA.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Stage 1: Healthy people | No intervention | –To establish a baseline and ensure reliability, and to develop a training protocol for stage 3. |
| Stage 2: Short-term training SCA people | Experimental | Other: ES Cycling TrainingShort-term ES Cycling Training |
| Stage 2: SCA Control group | No intervention | –Control Group |
| Stage 3:Long-term training SCA people | Experimental | Other: ES Cycling TrainingLong-term ES Cycling Training |
| Stage 3: SCA Control group | No intervention | –Control group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of SCA.
Key exclusion criteria (6 listed)
- Musculoskeletal injuries on legs.
- Osteoporosis.
- Musculoskeletal injuries on legs
- Osteoporosis.
- Any peripheral or central nervous system injury or disease patients.
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 |
|---|---|---|
| ES Cycling TrainingImplementing Electrical Stimulation (ES) Cycling combined with priming strategies to enhance motor learning tasks | Other | Stage 2: Short-term training SCA people, Stage 3:Long-term training SCA people |
Primary outcome
Overall Response Time
Time frame: Baseline, 2 weeks and 4 weeks
The sum of reaction time and movement time, providing a complete measure of the time taken from the stimulus presentation to the completion of the response. Unit: Second(s)
Overall Error Rate
Time frame: Baseline, 2 weeks and 4 weeks
The total proportion of incorrect responses across a testing session or series of tasks.
Motor Evoked Potentials (MEPs)
Time frame: Baseline, 2 weeks and 4 weeks
MEPs are the electrical responses recorded from muscles following stimulation of the motor cortex. They reflect the efficiency of neural transmission from the cortex to the muscle. Unit: millivolts (mV).
Intracortical Facilitation (ICF)
Time frame: Baseline, 2 weeks, and 4 weeks.
ICF is measured by applying a pair of TMS pulses with a short interval (e.g., 8-15 ms) where the first (subthreshold) pulse is followed by a second (suprathreshold) pulse, leading to an increased amplitude of the MEP.
Intracortical Inhibition (ICI)
Time frame: Baseline, 2 weeks, and 4 weeks.
ICI is measured similarly to ICF but with a shorter inter-stimulus interval (e.g., 1-5 ms), resulting in a suppressed MEP amplitude. This suppression reflects inhibitory processes within the cortex.
Total Scale for the Assessment and Rating of Ataxia (SARA) Score
Time frame: Baseline, 2 weeks, and 4 weeks.
To objectively assess ataxia severity across various domains of motor function including gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movements, and heel-shin slide. Each item is scored individually with a scale that typically ranges from 0 (no ataxia) to a maximum score that depends on the severity and the aspect of ataxia being assessed. The total score ranges from 0 (no ataxia) to 40 (most severe ataxia).
Total Berg Balance Scale (BBS) Score
Time frame: Baseline, 2 weeks, and 4 weeks.
To measure an individual's balance abilities through various tasks that mimic daily activities, assessing the risk of falls and overall balance proficiency. The BBS consists of 14 items that evaluate a range of functions including sitting to standing, standing unsupported, transferring, turning to look behind, picking up an object from the floor, and standing on one leg. Each task is rated on a scale from 0 (unable) to 4 (independent), with the total score ranging from 0 to 56. A higher total score indicates better balance and lower fall risk. Scores below 45 are generally indicative of increased fall risk.
Total Time to Complete the Time Up and Go test (TUG test)
Time frame: Baseline, 2 weeks, and 4 weeks.
The time, in seconds, it takes for a participant to complete the TUG test from the initial sitting position to returning to the seated position. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.
Walking Speed
Time frame: Baseline, 2 weeks, and 4 weeks.
The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).
Step Length
Time frame: Baseline, 2 weeks, and 4 weeks.
The linear distance between the two ankles, typically expressed in centimeter(cm).
Step Time
Time frame: Baseline, 2 weeks, and 4 weeks.
The duration taken for one complete step, measuring from foot-off of one foot to the next foot-off of the same foot, usually expressed in seconds.
5 secondary outcomes
Double Support Time
Time frame: Baseline, 2 weeks, and 4 weeks.
Single Support Time
Time frame: Baseline, 2 weeks, and 4 weeks.
Swing Time
Time frame: Baseline, 2 weeks, and 4 weeks.
Stance Time
Time frame: Baseline, 2 weeks, and 4 weeks.
Cadence
Time frame: Baseline, 2 weeks, and 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
Related trials for Spinocerebellar Ataxia (SCA)
Not yet recruitingObservational study
Multi-Modal Digital Monitoring of Disease Symptoms in Spinocerebellar Ataxia
Spinocerebellar Ataxia (SCA)
RecruitingObservational study
Natural History Study of and Genetic Modifiers in Spinocerebellar Ataxias
Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2
Recruiting
Interposed Nucleus aDBS for Ataxia
Spinocerebellar Ataxia (SCA), Spinocerebellar Ataxia Type 6
Recruiting
Deep Brain Stimulation for Spinocerebellar Ataxia
Spinocerebellar Ataxia (SCA), Spinocerebellar Ataxia Type 6
Active, not recruitingPhase 3
Troriluzole in Adult Participants With Spinocerebellar Ataxia
Spinocerebellar Ataxias, Spinocerebellar Ataxia Type 1
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ES Cycling Training in people with Spinocerebellar Ataxia (SCA), run by Chang Gung University at 1 site in Taiwan.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Ju Chang, PhD (88632118800 ext. 5515, yjchang@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Time (time frame: Baseline, 2 weeks and 4 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2024.