Effects and Mechanisms of RAS Training on Upper-limb Movements in PD Patients

Study Overview
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Brief Summary
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Introduction Bradykinesia (i.e., slow movements) is one of the most prominent symptoms of Parkinson's disease (PD) and has a negative impact on quality of life. Rhythmic auditory stimulation (RAS), a widely used and promising treatment technique, has been shown to effectively improve gait speed in PD patients. However, only few studies have explored effects and neural mechanisms of RAS on upper-limb movements. We will conduct two studies to investigate effects and mechanisms of RAS on upper-limb movements in PD patients. The purpose of this study is to examine effects and neural mechanisms of upper-limb movement training involving RAS in PD patients. Methods This study will recruit patients with PD and healthy controls. This study will randomly assign PD patients into two groups: the PD-RAS group and the PD-noRAS group, and healthy controls into the HC-RAS group and the HC-noRAS group. A 7-day upper-limb training involving RAS (for the PD-RAS group and the HC-RAS group) or without RAS (for the PD-noRAS group and the HC-noRAS group) will be provided. EEG and behavioral assessments will be conducted before and after the first day of training, and after the seven-day training program. Two-way repeated measures analysis of variance will be performed to investigate the group and time effects on upper-limb function and neural activity. Study significance The training program will serve as a reference for clinical practitioners who are interested in using RAS in clinical training for PD patients.

Official Title
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Effects and Neural Mechanisms of Training Involving Rhythmic Auditory Stimulation on Upper-limb Movements in Patients With Parkinson's Disease

Conditions
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Acoustic Stimulation, Parkinson Disease, Electroencephalography

Intervention / Treatment
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* Behavioral: Upper-limb training involving RAS
* Behavioral: Upper-limb training without the aid of RAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (a) idiopathic PD diagnosed by a neurologist based on the Movement Disorders Society clinical diagnostic criteria; (b) the Hoehn and Yahr stage is 2 or 3, meaning that bilateral movement problems or combination with mild postural instability; (c) a score of Montreal Cognitive Assessment (MoCA) is equal to or higher than 21 to ensure that they understand experimental instructions; (d) a score of Edinburgh Handedness Inventory is above 60 to ensure that they are right-handed; (e) types and doses of medications remain unchanged in the past month right before participation. Age- and sex-matched healthy controls who filled the criteria (c) and (d) will be recruited from communities. Exclusion Criteria: the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD-RAS<br>training involving RAS | Behavioral: Upper-limb training involving RAS<br>* Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient. Patients will be asked to listen to the RAS sound, use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They should keep their movements consistent with the sound of the RAS, with one RAS sound corresponding to one pick-up movement. Each daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 7 days.<br>|
| Active Comparator: PD-noRAS<br>training without the aid of RAS | Behavioral: Upper-limb training without the aid of RAS<br>* Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient. Patients will be asked to use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They are asked to execute the task as fast as possible. Each daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 7 days.<br>|
| Experimental: HC-RAS<br>training involving RAS | Behavioral: Upper-limb training involving RAS<br>* Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient. Patients will be asked to listen to the RAS sound, use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They should keep their movements consistent with the sound of the RAS, with one RAS sound corresponding to one pick-up movement. Each daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 7 days.<br>|
| Active Comparator: HC-noRAS<br>training without the aid of RAS | Behavioral: Upper-limb training without the aid of RAS<br>* Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient. Patients will be asked to use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They are asked to execute the task as fast as possible. Each daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroencephalography (EEG) | The power (unit:Watt) of EEG will be calculated. | Assessments will be performed before the first day of training. | 
| Electroencephalography (EEG) | The power (unit:Watt) of EEG will be calculated. | Assessments will be performed after the first day of training. | 
| Electroencephalography (EEG) | The power (unit:Watt) of EEG will be calculated. | Assessments will be performed after the seven-day training program. | 
| Electroencephalography (EEG) | The functional connectivity (unit:coherence) of EEG will be calculated. | Assessments will be performed before the first day of training. | 
| Electroencephalography (EEG) | The functional connectivity (unit:coherence) of EEG will be calculated. | Assessments will be performed after the first day of training. | 
| Electroencephalography (EEG) | The functional connectivity (unit:coherence) of EEG will be calculated. | Assessments will be performed after the seven-day training program. | 
| The box and block test (BBT) | The BBT is used to measure gross manual dexterity as well as upper-limb movement speed. | Assessments will be performed before the first day of training. | 
| The box and block test (BBT) | The BBT is used to measure gross manual dexterity as well as upper-limb movement speed. | Assessments will be performed after the first day of training. | 
| The box and block test (BBT) | The BBT is used to measure gross manual dexterity as well as upper-limb movement speed. | Assessments will be performed after the seven-day training program. | 
| The nine hole peg test (NHPT) | The NHPT is a widely used measure of hand dexterity in a broad range of ages and populations. | Assessments will be performed before the first day of training. | 
| The nine hole peg test (NHPT) | The NHPT is a widely used measure of hand dexterity in a broad range of ages and populations. | Assessments will be performed after the first day of training. | 
| The nine hole peg test (NHPT) | The NHPT is a widely used measure of hand dexterity in a broad range of ages and populations. | Assessments will be performed after the seven-day training program. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acoustic Stimulation, Parkinson Disease, Movement, Electroencephalography