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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05782322
• Other study ID #: HongKongPU21037721r_20230221
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2023
• Source: The Hong Kong Polytechnic University
• Contact: Wei FAN (PhD student), MSc
• Phone: +825 67681229
• Email: 21037721r[@]connect.polyu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acoustic Stimulation
• Electroencephalography
• Parkinson Disease

Intervention

Behavioral:
• Upper-limb training involving RAS
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.
• Upper-limb training without the aid of RAS
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

References & Publications (14)

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Braunlich K, Seger CA, Jentink KG, Buard I, Kluger BM, Thaut MH. Rhythmic auditory cues shape neural network recruitment in Parkinson's disease during repetitive motor behavior. Eur J Neurosci. 2019 Mar;49(6):849-858. doi: 10.1111/ejn.14227. Epub 2018 Dec 3. — View Citation

Buard I, Dewispelaere WB, Thaut M, Kluger BM. Preliminary Neurophysiological Evidence of Altered Cortical Activity and Connectivity With Neurologic Music Therapy in Parkinson's Disease. Front Neurosci. 2019 Feb 19;13:105. doi: 10.3389/fnins.2019.00105. eCollection 2019. — View Citation

Cahn DA, Sullivan EV, Shear PK, Pfefferbaum A, Heit G, Silverberg G. Differential contributions of cognitive and motor component processes to physical and instrumental activities of daily living in Parkinson's disease. Arch Clin Neuropsychol. 1998 Oct;13(7):575-83. — View Citation

Chen JL, Penhune VB, Zatorre RJ. Listening to musical rhythms recruits motor regions of the brain. Cereb Cortex. 2008 Dec;18(12):2844-54. doi: 10.1093/cercor/bhn042. Epub 2008 Apr 3. — View Citation

Dalrymple-Alford JC, MacAskill MR, Nakas CT, Livingston L, Graham C, Crucian GP, Melzer TR, Kirwan J, Keenan R, Wells S, Porter RJ, Watts R, Anderson TJ. The MoCA: well-suited screen for cognitive impairment in Parkinson disease. Neurology. 2010 Nov 9;75(19):1717-25. doi: 10.1212/WNL.0b013e3181fc29c9. — View Citation

Desrosiers J, Bravo G, Hebert R, Dutil E, Mercier L. Validation of the Box and Block Test as a measure of dexterity of elderly people: reliability, validity, and norms studies. Arch Phys Med Rehabil. 1994 Jul;75(7):751-5. — View Citation

Dong VA, Fong KN, Chen YF, Tseng SS, Wong LM. 'Remind-to-move' treatment versus constraint-induced movement therapy for children with hemiplegic cerebral palsy: a randomized controlled trial. Dev Med Child Neurol. 2017 Feb;59(2):160-167. doi: 10.1111/dmcn.13216. Epub 2016 Aug 9. — View Citation

Fan W, Li J, Wei W, Xiao SH, Liao ZJ, Wang SM, Fong KNK. Effects of rhythmic auditory stimulation on upper-limb movements in patients with Parkinson's disease. Parkinsonism Relat Disord. 2022 Aug;101:27-30. doi: 10.1016/j.parkreldis.2022.06.020. Epub 2022 Jun 23. — View Citation

Ghai S, Ghai I, Schmitz G, Effenberg AO. Effect of rhythmic auditory cueing on parkinsonian gait: A systematic review and meta-analysis. Sci Rep. 2018 Jan 11;8(1):506. doi: 10.1038/s41598-017-16232-5. — View Citation

Koshimori Y, Thaut MH. Future perspectives on neural mechanisms underlying rhythm and music based neurorehabilitation in Parkinson's disease. Ageing Res Rev. 2018 Nov;47:133-139. doi: 10.1016/j.arr.2018.07.001. Epub 2018 Jul 10. — View Citation

Leuk JSP, Low LLN, Teo WP. An Overview of Acoustic-Based Interventions to Improve Motor Symptoms in Parkinson's Disease. Front Aging Neurosci. 2020 Aug 14;12:243. doi: 10.3389/fnagi.2020.00243. eCollection 2020. — View Citation

Thaut MH, McIntosh GC, Rice RR, Miller RA, Rathbun J, Brault JM. Rhythmic auditory stimulation in gait training for Parkinson's disease patients. Mov Disord. 1996 Mar;11(2):193-200. doi: 10.1002/mds.870110213. — View Citation

Wang SM, Chan ST, Wong YL, Hsu HM, Lee CY, Check CY, Leung CK. Rhythmic auditory stimulation incorporated in training improved movements in individuals with psychotic-like experiences. Eur Arch Psychiatry Clin Neurosci. 2022 Nov 24. doi: 10.1007/s00406-022-01524-3. Online ahead of print. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electroencephalography (EEG)	The power (unit:Watt) of EEG will be calculated.	Assessments will be performed before the first day of training.
Primary	Electroencephalography (EEG)	The power (unit:Watt) of EEG will be calculated.	Assessments will be performed after the first day of training.
Primary	Electroencephalography (EEG)	The power (unit:Watt) of EEG will be calculated.	Assessments will be performed after the seven-day training program.
Primary	Electroencephalography (EEG)	The functional connectivity (unit:coherence) of EEG will be calculated.	Assessments will be performed before the first day of training.
Primary	Electroencephalography (EEG)	The functional connectivity (unit:coherence) of EEG will be calculated.	Assessments will be performed after the first day of training.
Primary	Electroencephalography (EEG)	The functional connectivity (unit:coherence) of EEG will be calculated.	Assessments will be performed after the seven-day training program.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.