Rhythmic Auditory Stimulation on Neural Activity During Finger-tapping in PD Patients

April 28, 2023 updated by: FAN Wei, The Hong Kong Polytechnic University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with Parkinson's disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PD patients
Patients with Parkinson's disease
Behavioral: noF-noRAS
resting state, that is, without finger-tapping and without listening to RAS
Behavioral: F-noRAS
finger-tapping without listening to RAS
Behavioral: noF-100RAS
listening to RAS with the 100% of the baseline tempo and without finger-tapping
Behavioral: F-100RAS
finger-tapping and listening to RAS with 100 % of baseline tempo
Behavioral: F-105RAS
finger-tapping and listening to RAS with 105 % of baseline tempo
Behavioral: F-110RAS
finger-tapping and listening to RAS with 110 % of baseline tempo
Healthy controls
Healthy older adults
Behavioral: noF-noRAS
resting state, that is, without finger-tapping and without listening to RAS
Behavioral: F-noRAS
finger-tapping without listening to RAS
Behavioral: noF-100RAS
listening to RAS with the 100% of the baseline tempo and without finger-tapping
Behavioral: F-100RAS
finger-tapping and listening to RAS with 100 % of baseline tempo
Behavioral: F-105RAS
finger-tapping and listening to RAS with 105 % of baseline tempo
Behavioral: F-110RAS
finger-tapping and listening to RAS with 110 % of baseline tempo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Wei FAN (PhD student), MSc, Rehabilitation Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

March 31, 2026

Study Completion (Anticipated)

March 31, 2026

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HongKongPU21037721r_20230220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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