Electrical Stimulation Cycling Training Effects on SCA

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.

Study Overview

• Status: Recruiting
• Conditions: Spinocerebellar Ataxia (SCA)
• Intervention / Treatment: Other: ES Cycling Training

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 Type: Interventional
• Enrollment (Estimated): 145
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ya-Ju Chang, PhD; Phone Number: 5515 88632118800; Email: yjchang@mail.cgu.edu.tw

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung University
    • Contact: Ya-Ju Chang, PhD; Phone Number: 5515 88632118800; Email: yjchang@mail.cgu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Health subjects:

Exclusion Criteria:

• Musculoskeletal injuries on legs.
• Osteoporosis.

SCA subjects:

Inclusion Criteria:

- Clinical diagnosis of SCA.

Exclusion Criteria:

• Musculoskeletal injuries on legs
• Osteoporosis.
• Any peripheral or central nervous system injury or disease patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Stage 1: Healthy people; To establish a baseline and ensure reliability, and to develop a training protocol for stage 3.
Experimental: Stage 2: Short-term training SCA people; Short-term ES Cycling Training	Other: ES Cycling Training; Implementing Electrical Stimulation (ES) Cycling combined with priming strategies to enhance motor learning tasks
Experimental: Stage 3:Long-term training SCA people; Long-term ES Cycling Training	Other: ES Cycling Training; Implementing Electrical Stimulation (ES) Cycling combined with priming strategies to enhance motor learning tasks
No Intervention: Stage 2: SCA Control group; Control Group
No Intervention: Stage 3: SCA Control group; Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline, 2 weeks and 4 weeks
Overall Error Rate	The total proportion of incorrect responses across a testing session or series of tasks.	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).	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.	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.	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).	Baseline, 2 weeks, and 4 weeks.
Step Length	The linear distance between the two ankles, typically expressed in centimeter(cm).	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.	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).	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.	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.	Baseline, 2 weeks, and 4 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	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.	Baseline, 2 weeks, and 4 weeks.

Collaborators and Investigators

• Sponsor: Chang Gung University

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2022
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Motor Control; Motor Learning; Priming; Excitability
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Neurodegenerative Diseases; Dyskinesias; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Cerebellar Diseases; Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations
• Other Study ID Numbers: 201902166B0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No