NMT for Parkinson's Disease

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Other: Neurologic Music Therapy; Other: Occupational Therapy; Other: Music Supported Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03049033

K01AT009894 (U.S. NIH Grant/Contract)

16-2308

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups

Neurologic Music Therapy (NMT)

Experimental group

Description:

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

Treatment:

Other: Neurologic Music Therapy

Occupational Therapy (OT)

Active Comparator group

Description:

Standard of care occupational therapy uses traditional motor training.

Treatment:

Other: Occupational Therapy

Waitlist Control

No Intervention group

Description:

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 group

Description:

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

Treatment:

Other: Music Supported Therapy