Parkinson DiseaseNCT03049033
NMT for Parkinson's Disease
A study testing Neurologic Music Therapy, Occupational Therapy and Music Supported Therapy in people with Parkinson Disease, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Parkinson's Disease (PD) is defined by characteristic motor symptoms including slow movements, small movements, difficulty with movement initiation and disruptions in timing. Besides gross motor symptoms, fine motor impairments in PD cause difficulties with everyday tasks such as writing, self-care, and fine object… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Neurologic Music Therapy, Occupational Therapy and Music Supported Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2017to 31 Dec 2025
- Phase
- Interventional
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 to 85
- Diagnosis of Parkinson's Disease using the UK Brain Bank Criteria
- Fine motor impairments (if available, scores 2 and higher on the UPDRS motor examination part III.23 and 24)
- Medication stable for at least 30 days.
Who cannot join
- Features suggestive of other causes of parkinsonism, including cerebrovascular disease or history of major head trauma
- Inability to move fingers or hands
- Hoehn and Yahr stage 4 and higher
- Ferrous metal implants which may interfere with the MEG data acquisition and/or be an MRI safety concern
- Dementia
- Participants engaged in other research studies involving music therapies
- Participants whose insurance does not cover Occupational Therapy costs or who have no insurance.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80045
Lucas Lattanzio, BA, 303-724-2205, Lucas.Lattanzio@CUAnschutz.edu
Isabelle Buard, PhD, 303-724-5973, Isabelle.Buard@CUAnschutz.edu
About this study
Official title: Neurologic Music Therapy for Enhancing Fine Motor Control in Parkinson's Disease
Parkinson's Disease (PD) is defined by characteristic motor symptoms including slow movements, small movements, difficulty with movement initiation and disruptions in timing. Besides gross motor symptoms, fine motor impairments in PD cause difficulties with everyday tasks such as writing, self-care, and fine object manipulation. These activity limitations can lead to disability, social isolation, and a reduced quality of life. In a series of breakthrough studies Michael Thaut and colleagues developed Neurologic Music Therapy (NMT) and found it can address many gross motor impairments and improve gait and balance. Other music therapies such as Music-supported Therapy (MST) have proven motor benefits in stroke patients through movement exercises with musical instruments. However, the pathological basal ganglia (BG) in PD brains leads to a reduced supply of those internally generated movements. In contrast, externally cued movements (eg. via a beat or a rhythm) during NMT sessions are instantaneously entrained to the period of a rhythmic stimulus possibly without involvement of the BG. The underlying idea is that rhythm is the essential component relating music specifically to motor behavior. The mechanism of action is called "rhythmic entrainment" where one system's motion or signal frequency entrains the frequency of another system. The effect of NMT on fine motor function has not been investigated yet. Music activities are important in the lives of many older adults. Notably, the use of music has been associated with increased well-being for older adults, as it fosters social connection and mood regulation. Furthermore, many musical activities have limited physical demands, making them attainable for individuals who are living with mobility impairments or other physical restrictions. Based on the literature and the investigators preliminary studies, the investigators propose to test the efficacy of Neurologic Music Therapy in comparison to Music Supported Therapy and Occupational Therapy (OT) as standard of care on adults in the Parkinson's spectrum. The investigators have defined a working plan using different musical instruments and growing tempo to specifically improve fine motor movements.
- Conditions
- Parkinson Disease
- Being tested
- Neurologic Music Therapy, Occupational Therapy, Music Supported Therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurologic Music TherapyOther
Neurologic Music Therapy uses rhythms to change brain activity and function.
Occupational TherapyOther
Occupational Therapy uses traditional motor training.
Music Supported TherapyOther
Music Supported Therapy uses musical instruments to train fine motor movements.
| Study group | Role | What they receive |
|---|---|---|
| Neurologic Music Therapy (NMT) | Experimental | Neurologic Music Therapy is a 5-week intervention using different musical instruments and auditory cues to specifically improve fine motor movements. Receives: Other: Neurologic Music Therapy |
| Occupational Therapy (OT) | Active comparator | Standard of care occupational therapy uses traditional motor training. Receives: Other: Occupational Therapy |
| Waitlist Control | No intervention | Participants assigned to the waitlist-control condition will not immediately receive services. The no-treatment duration for these participants is yoked to the amount of time their respective NMT- and OT-condition participants receive services (5 weeks). After the wait period, these participants will then be randomized to receive either NMT, MST or OT sessions. |
| Music Supported Therapy (MST) | Active comparator | Music Supported Therapy uses musical instruments to train fine motor movements. Receives: Other: Music Supported Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome: Motor 1 (change in the Grooved Pegboard Test)
First motor outcome will be a change in the Grooved Pegboard Test.
Measured: Baseline and 5 weeks
Quality of Life (QOL) Outcome: QOL 1 (change in the 39-Item Parkinson's Disease)
First QOL outcome will be a change in the 39-Item Parkinson's Disease Questionnaire.
Measured: Baseline and 5 weeks
Mechanistic Outcome: Neurophysiology 1 (change in motor beta and gamma power using Magnetoencephalography)
Our first mechanistic outcome will be a change in cortical motor beta and gamma power using Magnetoencephalography.
Measured: Baseline and 5 weeks
Mechanistic Outcome: Neurophysiology 2 (change in auditory-motor functional connectivity using Magnetoencephalography)
Our second neurophysiology outcome will be a change in auditory-motor functional connectivity using Magnetoencephalography
Measured: Baseline and 5 weeks
Secondary outcomes (4)
Clinical Outcome: Motor 2 (change in the Unified Parkinson Disease Rating Scale Part III)
Secondary motor outcome will be a change in the Unified Parkinson Disease Rating Scale Part III.
Measured: Baseline and 5 weeks
Clinical Outcome: Motor 3 (change in the Finger-Thumb opposition from the Neurological Evaluation Scale)
Secondary motor outcome will be a change in the Finger-Thumb opposition from the Neurological Evaluation Scale.
Measured: Baseline and 5 weeks
Quality of Life (QOL) Outcome: QOL 2 (change in the Clinical Global Impression - Improvement Scale)
Second QOL outcomes will be a change in the Clinical Global Impression - Improvement Scale .
Measured: Baseline and 5 weeks
Quality of Life (QOL) Outcome: QOL 3 (change in the Hospital Anxiety and Depression Scale)
Second QOL outcomes will be a change in the Hospital Anxiety and Depression Scale.
Measured: Baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start26 Apr 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Isabelle Buard, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049033
- Sponsor's protocol ID
- 16-2308
- Other IDs
- K01AT009894
- Status last verified
- Jan 2024
- First submitted
- 2 Feb 2017
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available to the scientific community upon request. Data sharing will include motor tests, questionnaires and MEG raw data.
Publications
Buard I, Lattanzio L, Stewart R, Thompson S, Sjoberg K, Hookstadt K, Morrow M, Holden SK, Sillau S, Thaut M, Kluger B. Randomized controlled trial of neurologic music therapy in Parkinson's disease: research rehabilitation protocols for mechanistic and clinical investigations. Trials. 2021 Aug 28;22(1):577. doi: 10.1186/s13063-021-05560-7.
PubMed 34454592
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurologic Music Therapy for Enhancing Fine Motor Control in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03049033
- Acronym / sponsor ID
- 16-2308
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- 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.
Parkinson's Disease (PD) is defined by characteristic motor symptoms including slow movements, small movements, difficulty with movement initiation and disruptions in timing. Besides gross motor symptoms, fine motor impairments in PD cause difficulties with everyday tasks such as writing, self-care, and fine object manipulation. These activity limitations can lead to disability, social isolation, and a reduced quality of life. In a series of breakthrough studies Michael Thaut and colleagues developed Neurologic Music Therapy (NMT) and found it can address many gross motor impairments and improve gait and balance. Other music therapies such as Music-supported Therapy (MST) have proven motor benefits in stroke patients through movement exercises with musical instruments. However, the pathological basal ganglia (BG) in PD brains leads to a reduced supply of those internally generated movements. In contrast, externally cued movements (eg. via a beat or a rhythm) during NMT sessions are instantaneously entrained to the period of a rhythmic stimulus possibly without involvement of the BG. The underlying idea is that rhythm is the essential component relating music specifically to motor behavior. The mechanism of action is called "rhythmic entrainment" where one system's motion or signal frequency entrains the frequency of another system. The effect of NMT on fine motor function has not been investigated yet. Music activities are important in the lives of many older adults. Notably, the use of music has been associated with increased well-being for older adults, as it fosters social connection and mood regulation. Furthermore, many musical activities have limited physical demands, making them attainable for individuals who are living with mobility impairments or other physical restrictions. Based on the literature and the investigators preliminary studies, the investigators propose to test the efficacy of Neurologic Music Therapy in comparison to Music Supported Therapy and Occupational Therapy (OT) as standard of care on adults in the Parkinson's spectrum. The investigators have defined a working plan using different musical instruments and growing tempo to specifically improve fine motor movements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neurologic Music Therapy (NMT) | Experimental | Other: Neurologic Music TherapyNeurologic Music Therapy is a 5-week intervention using different musical instruments and auditory cues to specifically improve fine motor movements. |
| Occupational Therapy (OT) | Active comparator | Other: Occupational TherapyStandard of care occupational therapy uses traditional motor training. |
| Waitlist Control | No intervention | –Participants assigned to the waitlist-control condition will not immediately receive services. The no-treatment duration for these participants is yoked to the amount of time their respective NMT- and OT-condition participants receive services (5 weeks). After the wait period, these participants will then be randomized to receive either NMT, MST or OT sessions. |
| Music Supported Therapy (MST) | Active comparator | Other: Music Supported TherapyMusic Supported Therapy uses musical instruments to train fine motor movements. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 45 to 85
- Diagnosis of Parkinson's Disease using the UK Brain Bank Criteria
- Fine motor impairments (if available, scores 2 and higher on the UPDRS motor examination part III.23 and 24)
- Medication stable for at least 30 days.
Key exclusion criteria (7 listed)
- Features suggestive of other causes of parkinsonism, including cerebrovascular disease or history of major head trauma
- Inability to move fingers or hands
- Hoehn and Yahr stage 4 and higher
- Ferrous metal implants which may interfere with the MEG data acquisition and/or be an MRI safety concern
- Dementia
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 |
|---|---|---|
| Neurologic Music TherapyNeurologic Music Therapy uses rhythms to change brain activity and function. | Other | Neurologic Music Therapy (NMT) |
| Occupational TherapyOccupational Therapy uses traditional motor training. | Other | Occupational Therapy (OT) |
| Music Supported TherapyMusic Supported Therapy uses musical instruments to train fine motor movements. | Other | Music Supported Therapy (MST) |
Primary outcome
Clinical Outcome: Motor 1 (change in the Grooved Pegboard Test)
Time frame: Baseline and 5 weeks
First motor outcome will be a change in the Grooved Pegboard Test.
Quality of Life (QOL) Outcome: QOL 1 (change in the 39-Item Parkinson's Disease)
Time frame: Baseline and 5 weeks
First QOL outcome will be a change in the 39-Item Parkinson's Disease Questionnaire.
Mechanistic Outcome: Neurophysiology 1 (change in motor beta and gamma power using Magnetoencephalography)
Time frame: Baseline and 5 weeks
Our first mechanistic outcome will be a change in cortical motor beta and gamma power using Magnetoencephalography.
Mechanistic Outcome: Neurophysiology 2 (change in auditory-motor functional connectivity using Magnetoencephalography)
Time frame: Baseline and 5 weeks
Our second neurophysiology outcome will be a change in auditory-motor functional connectivity using Magnetoencephalography
4 secondary outcomes
Clinical Outcome: Motor 2 (change in the Unified Parkinson Disease Rating Scale Part III)
Time frame: Baseline and 5 weeks
Clinical Outcome: Motor 3 (change in the Finger-Thumb opposition from the Neurological Evaluation Scale)
Time frame: Baseline and 5 weeks
Quality of Life (QOL) Outcome: QOL 2 (change in the Clinical Global Impression - Improvement Scale)
Time frame: Baseline and 5 weeks
Quality of Life (QOL) Outcome: QOL 3 (change in the Hospital Anxiety and Depression Scale)
Time frame: Baseline and 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 34454592Buard I, Lattanzio L, Stewart R, Thompson S, Sjoberg K, Hookstadt K, Morrow M, Holden SK, Sillau S, Thaut M, Kluger B. Randomized controlled trial of neurologic music therapy in Parkinson's disease: research rehabilitation protocols for mechanistic and clinical investigations. Trials. 2021 Aug 28;22(1):577. doi: 10.1186/s13063-021-05560-7.
- Individual participant dataSharing planned: Yes. De-identified data will be made available to the scientific community upon request. Data sharing will include motor tests, questionnaires and MEG raw data.
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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.
Isabelle Buard, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurologic Music Therapy, Occupational Therapy and Music Supported Therapy in people with Parkinson Disease, run by University of Colorado, Denver at 1 site in United States.
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 4 inclusion and 7 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 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Lucas Lattanzio, BA (303.724.2205, Lucas.Lattanzio@CUAnschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcome: Motor 1 (change in the Grooved Pegboard Test) (time frame: Baseline and 5 weeks). The study lists 4 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 NCT03049033, which also lists 1 linked publication.
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 Jan 2024.