PAS Balance Training for Parkinson Disease (PD)

NCT06598891 | Recruiting

• 1 other identifier: PD_002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Gait initiation (GI) difficulty is a common problem in individuals with Parkinson's disease (PD), often linked to impaired anticipatory postural adjustments (APA). Currently, there are no targeted rehabilitation programs designed specifically for GI-related APA in PD patients. Research has shown that while motor learning deficits are common in PD, explicit learning is better preserved than implicit learning. Therefore, a GI-related APA training system using an explicit learning model could be particularly effective for this population. During motor learning, long-term potentiation (LTP) increases the excitability of the primary motor cortex. Paired associative stimulation (PAS) has been demonstrated to induce LTP-like changes in the motor cortex, making it a potential priming method to enhance motor learning. However, the priming effect of PAS targeted at leg muscles and the motor cortex on motor learning related to GI-APA has not been previously studied. The objectives of this study are:

1. 1.To investigate the effects of explicit and implicit training on GI-related APA.
2. 2.To evaluate the priming effect of PAS on GI-related APA training and the associated plasticity changes in the motor cortex.

Conditions

PD - Parkinson's Disease

Keywords

Gait Initiation; Paired associative stimulation (PAS); Balance training; Motor learning; Anticipatory postural adjustment (APA)

Outcome Measures

Primary Outcomes (9)

• Balance Performance

  Measured by the duration the stance or stand can be maintained. Unit：second(s)

  Baseline, 4 weeks and 8 weeks

• COP Path Length in Balance Tasks

  The total distance traveled by the COP over a specified period. Longer path lengths can indicate increased effort to maintain balance or greater instability.

  Baseline, 4 weeks and 8 weeks

• COP Displacement in Balance Tasks

  Measures of COP movement in the anterior-posterior (AP) and medial-lateral (ML) directions, offering insights into the directional tendencies of balance control. Unit：millimeter(mm)

  Baseline, 4 weeks and 8 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, 4 weeks and 8 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, 4 weeks and 8 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, 4 weeks and 8 weeks

• Walking Speed

  The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).

  Baseline, 4 weeks and 8 weeks

• Step Length

  The linear distance between the two ankles, typically expressed in centimeter(cm).

  Baseline, 4 weeks and 8 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, 4 weeks and 8 weeks

Secondary Outcomes (7)

• COP Velocity in Balance Tasks

  Baseline, 4 weeks and 8 weeks

• COP Area in Balance Tasks

  Baseline, 4 weeks and 8 weeks

• Double Support Time

  Baseline, 4 weeks and 8 weeks

• Single Support Time

  Baseline, 4 weeks and 8 weeks

• Swing Time

  Baseline, 4 weeks and 8 weeks

Other Outcomes (1)

• Total UPDRS-III Score

  Baseline

Study Arms (2)

PD APA training group

EXPERIMENTAL

Weight shift training and APA feedback.

Procedure: Weight shift training and APA feedback

PD PAS group

EXPERIMENTAL

Using PAS to regulate brain plasticity

Procedure: Paired associative stimulation

Interventions

Weight shift training and APA feedback PROCEDURE

Use COP trajectory to train weight shift on force plate. To give APA visual feedback for subjects after weight shift training.

Also known as: APA training

PD APA training group

Paired associative stimulation PROCEDURE

Use TMS combine ES to stimulate TA nerve and M1 cortical

Also known as: PAS training

PD PAS group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Clinical diagnosis of Parkinson disease.

You may not qualify if:

• 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

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

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

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: October 9, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

TW (1)