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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05839821
Other study ID # HongKongPU21037721r_20230220
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date March 31, 2026

Study information

Verified date April 2023
Source The Hong Kong Polytechnic University
Contact Wei FAN (PhD student), MSc
Phone +85267681229
Email 21037721r@connect.polyu.hk
Is FDA regulated No
Health authority
Study type Observational

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. The investigators 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 real-time neural activity when patients with PD and healthy controls listen to RAS and execute finger-tapping task simultaneously. Methods and analysis This study will recruit patients with PD and healthy controls. Electroencephalography (EEG) will be used under six conditions related to a finger-tapping task. Two-way repeated measures analysis of variance will be performed to investigate the group and condition effects on neural mechanisms. Study significance This study will offer evidence on RAS effects and mechanisms by investigating the changes in upper-limb movements and neural mechanisms during auditory-motor entrainment. Results from this study will provide a solid foundation for further research and clinical applications of RAS.


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.

Study Design


Intervention

Behavioral:
noF-noRAS
resting state, that is, without finger-tapping and without listening to RAS
F-noRAS
finger-tapping without listening to RAS
noF-100RAS
listening to RAS with the 100% of the baseline tempo and without finger-tapping
F-100RAS
finger-tapping and listening to RAS with 100 % of baseline tempo
F-105RAS
finger-tapping and listening to RAS with 105 % of baseline tempo
F-110RAS
finger-tapping and listening to RAS with 110 % of baseline tempo

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

References & Publications (6)

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

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

Outcome

Type Measure Description Time frame Safety issue
Primary The spectral power analysis of Electroencephalography (EEG) The spectral power analysis (unit: watt) will be conducted EEG will be continuously recorded during the whole experiment, which is about 20 minutes.
Primary The functional connectivity analysis of Electroencephalography (EEG) The functional connectivity analysis (unit: coherence) will be conducted EEG will be continuously recorded during the whole experiment, which is about 20 minutes.
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