Acoustic StimulationNCT05839821
Rhythmic Auditory Stimulation on Neural Activity During Finger-tapping in PD Patients
An observational study of Acoustic Stimulation and Parkinson Disease, run by The Hong Kong Polytechnic University.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Acoustic Stimulation, Parkinson Disease, Electroencephalography
- What is being tested?
- noF-noRAS, F-noRAS and noF-100RAS
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Parkinson's disease
Who may be able to join
- (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.
Who cannot join
- the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Being tested
- noF-noRAS, F-noRAS, noF-100RAS, F-100RAS, F-105RAS
- Keywords
- Acoustic Stimulation, Parkinson Disease, Movement, Electroencephalography
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noF-noRASBehavioural
resting state, that is, without finger-tapping and without listening to RAS
F-noRASBehavioural
finger-tapping without listening to RAS
noF-100RASBehavioural
listening to RAS with the 100% of the baseline tempo and without finger-tapping
F-100RASBehavioural
finger-tapping and listening to RAS with 100 % of baseline tempo
F-105RASBehavioural
finger-tapping and listening to RAS with 105 % of baseline tempo
F-110RASBehavioural
finger-tapping and listening to RAS with 110 % of baseline tempo
| Study group | Role | What they receive |
|---|---|---|
| PD patients | Patients with Parkinson's disease Receives: Behavioral: noF-noRAS; Behavioral: F-noRAS; Behavioral: noF-100RAS; Behavioral: F-100RAS; Behavioral: F-105RAS; Behavioral: F-110RAS | |
| Healthy controls | Healthy older adults Receives: Behavioral: noF-noRAS; Behavioral: F-noRAS; Behavioral: noF-100RAS; Behavioral: F-100RAS; Behavioral: F-105RAS; Behavioral: F-110RAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The spectral power analysis of Electroencephalography (EEG)
The spectral power analysis (unit: watt) will be conducted
Measured: 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
Measured: EEG will be continuously recorded during the whole experiment, which is about 20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acoustic StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FAN Wei, The Hong Kong Polytechnic University
- Investigators
- Wei FAN (PhD student), MSc, Principal investigator, Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839821
- Sponsor's protocol ID
- HongKongPU21037721r_20230220
- Status last verified
- Apr 2023
- First submitted
- 24 Feb 2023
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35763906Wang 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.
PubMed 36422679Leuk 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.
PubMed 32922283Thaut 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.
PubMed 8684391Koshimori 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.
PubMed 30005957Dong 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.
PubMed 27503605
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Neural Mechanisms of Rhythmic Auditory Stimulation on Upper-limb Movements in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05839821
- Acronym / sponsor ID
- HongKongPU21037721r_20230220
- Keywords
- Acoustic Stimulation, Parkinson Disease, Movement, Electroencephalography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD patients | – | Behavioral: noF-noRAS, Behavioral: F-noRAS, Behavioral: noF-100RAS, Behavioral: F-100RAS, Behavioral: F-105RAS, Behavioral: F-110RASPatients with Parkinson's disease |
| Healthy controls | – | Behavioral: noF-noRAS, Behavioral: F-noRAS, Behavioral: noF-100RAS, Behavioral: F-100RAS, Behavioral: F-105RAS, Behavioral: F-110RASHealthy older adults |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease
Key inclusion criteria (6 listed)
- (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.
Key exclusion criteria (1 listed)
- the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| noF-noRASresting state, that is, without finger-tapping and without listening to RAS | Behavioural | Healthy controls, PD patients |
| F-noRASfinger-tapping without listening to RAS | Behavioural | Healthy controls, PD patients |
| noF-100RASlistening to RAS with the 100% of the baseline tempo and without finger-tapping | Behavioural | Healthy controls, PD patients |
| F-100RASfinger-tapping and listening to RAS with 100 % of baseline tempo | Behavioural | Healthy controls, PD patients |
| F-105RASfinger-tapping and listening to RAS with 105 % of baseline tempo | Behavioural | Healthy controls, PD patients |
| F-110RASfinger-tapping and listening to RAS with 110 % of baseline tempo | Behavioural | Healthy controls, PD patients |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Background: PubMed 35763906Fan 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.
- Background: PubMed 36422679Wang 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.
- Background: PubMed 32922283Leuk 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.
- Background: PubMed 8684391Thaut 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.
- Background: PubMed 30005957Koshimori 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.
- Background: PubMed 27503605Dong 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.
- Individual participant dataSharing planned: No
Related trials for Acoustic Stimulation
Recruiting
Acoustic Stimulation, Sleep, and Cognitive-Emotional Processes in Young Adults With Anxiety and Depression Symptoms
Acoustic Stimulation
Not yet recruiting
Personalized Sensory Stimulation: Urban and Rural Dementia Care
Dementia, Acoustic Stimulation
Not yet recruiting
Effects and Mechanisms of RAS Training on Upper-limb Movements in PD Patients
Acoustic Stimulation, Parkinson Disease
Recruiting
Acoustic Stimulation During Restricted Sleep After Sleep Deprivation
Sleep Deprivation, Sleep Restriction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei FAN (PhD student), MSc principal investigator
Rehabilitation Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Acoustic Stimulation and Parkinson Disease, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei FAN (PhD student), MSc (+85267681229, 21037721r@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The spectral power analysis of Electroencephalography (EEG) (time frame: EEG will be continuously recorded during the whole experiment, which is about 20 minutes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05839821, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023; AzTrials last refreshed its copy on 30 Oct 2026.