Electrical Stimulation Cycling Training Effects on SCA

NCT06363058 | Recruiting

• 1 other identifier: 201902166B0
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spinocerebellar Ataxia (SCA)

Keywords

Motor Control; Motor Learning; Priming; Excitability

Outcome Measures

Primary Outcomes (11)

• 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.

• 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.

• 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.

Secondary Outcomes (5)

• Double Support Time

  Baseline, 2 weeks, and 4 weeks.

• Single Support Time

  Baseline, 2 weeks, and 4 weeks.

• Swing Time

  Baseline, 2 weeks, and 4 weeks.

• Stance Time

  Baseline, 2 weeks, and 4 weeks.

• Cadence

  Baseline, 2 weeks, and 4 weeks.

Study Arms (5)

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

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

Other: ES Cycling Training

Stage 3: SCA Control group

NO INTERVENTION

Control group

Interventions

ES Cycling Training OTHER

Implementing Electrical Stimulation (ES) Cycling combined with priming strategies to enhance motor learning tasks

Stage 2: Short-term training SCA people; Stage 3:Long-term training SCA people

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Musculoskeletal injuries on legs.
• Osteoporosis.
• SCA subjects:
• \- Clinical diagnosis of SCA.
• Musculoskeletal injuries on legs
• Osteoporosis.
• Any peripheral or central nervous system injury or disease patients.

Sponsors & Collaborators

• Chang Gung University: lead

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Spinocerebellar Ataxias

Condition Hierarchy (Ancestors)

Cerebellar Ataxia; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ya-Ju Chang, PhD

CONTACT

88632118800; yjchang@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 12, 2024
• Study Start: April 8, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

TW (1)