NCT05839821

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

2.8 years

First QC Date

February 24, 2023

Last Update Submit

April 28, 2023

Conditions

Keywords

Acoustic StimulationParkinson DiseaseMovementElectroencephalography

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

PD patients

Patients with Parkinson's disease

Behavioral: noF-noRASBehavioral: F-noRASBehavioral: noF-100RASBehavioral: F-100RASBehavioral: F-105RASBehavioral: F-110RAS

Healthy controls

Healthy older adults

Behavioral: noF-noRASBehavioral: F-noRASBehavioral: noF-100RASBehavioral: F-100RASBehavioral: F-105RASBehavioral: F-110RAS

Interventions

noF-noRASBEHAVIORAL

resting state, that is, without finger-tapping and without listening to RAS

Healthy controlsPD patients
F-noRASBEHAVIORAL

finger-tapping without listening to RAS

Healthy controlsPD patients
noF-100RASBEHAVIORAL

listening to RAS with the 100% of the baseline tempo and without finger-tapping

Healthy controlsPD patients
F-100RASBEHAVIORAL

finger-tapping and listening to RAS with 100 % of baseline tempo

Healthy controlsPD patients
F-105RASBEHAVIORAL

finger-tapping and listening to RAS with 105 % of baseline tempo

Healthy controlsPD patients
F-110RASBEHAVIORAL

finger-tapping and listening to RAS with 110 % of baseline tempo

Healthy controlsPD patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Parkinson's disease

You may qualify if:

  • (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.

You may not qualify if:

  • the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 35763906BACKGROUND
  • 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. 2023 Jun;273(4):995-1005. doi: 10.1007/s00406-022-01524-3. Epub 2022 Nov 24.

    PMID: 36422679BACKGROUND
  • 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.

    PMID: 32922283BACKGROUND
  • 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.

    PMID: 8684391BACKGROUND
  • 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.

    PMID: 30005957BACKGROUND
  • 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.

    PMID: 27503605BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Wei FAN (PhD student), MSc

    Rehabilitation Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei FAN (PhD student), MSc

CONTACT

Shu-mei Wang (supervisor), PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

February 24, 2023

First Posted

May 3, 2023

Study Start

June 1, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share