NMT for Parkinson's Disease

NCT ID: NCT03049033

Last Updated: 2024-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-26

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Neurologic Music Therapy (NMT)

Neurologic Music Therapy is a 5-week intervention using different musical instruments and auditory cues to specifically improve fine motor movements.

Group Type EXPERIMENTAL

Neurologic Music Therapy

Intervention Type OTHER

Neurologic Music Therapy uses rhythms to change brain activity and function.

Occupational Therapy (OT)

Standard of care occupational therapy uses traditional motor training.

Group Type ACTIVE_COMPARATOR

Occupational Therapy

Intervention Type OTHER

Occupational Therapy uses traditional motor training.

Waitlist Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Music Supported Therapy (MST)

Music Supported Therapy uses musical instruments to train fine motor movements.

Group Type ACTIVE_COMPARATOR

Music Supported Therapy

Intervention Type OTHER

Music Supported Therapy uses musical instruments to train fine motor movements.

Interventions

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Neurologic Music Therapy

Neurologic Music Therapy uses rhythms to change brain activity and function.

Intervention Type OTHER

Occupational Therapy

Occupational Therapy uses traditional motor training.

Intervention Type OTHER

Music Supported Therapy

Music Supported Therapy uses musical instruments to train fine motor movements.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle Buard, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Denver

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lucas Lattanzio, BA

Role: CONTACT

303.724.2205

Isabelle Buard, PhD

Role: CONTACT

303.724.5973

Facility Contacts

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Lucas Lattanzio, BA

Role: primary

303-724-2205

Isabelle Buard, PhD

Role: backup

303-724-5973

References

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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.

Reference Type DERIVED
PMID: 34454592 (View on PubMed)

Other Identifiers

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K01AT009894

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-2308

Identifier Type: -

Identifier Source: org_study_id

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