Recruiting

NMT & MST

Sponsor:

University of Colorado, Denver

Code:

NCT03049033

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Neurologic Music Therapy

Occupational Therapy

Music Supported Therapy

Study Details

Brief 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 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

Study ID

NCT03049033

Start date

Apr 26, 2017

Status verified date

Jan, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Occupational Therapy (OT)

Standard of care occupational therapy uses traditional motor training.

no intervention: 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.

active comparator: Music Supported Therapy (MST)

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

Interventions

Neurologic Music Therapy

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

Occupational Therapy

Occupational Therapy uses traditional motor training.

Music Supported Therapy

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

Primary outcome measure

  • Clinical Outcome: Motor 1 (change in the Grooved Pegboard Test) [ Time Frame: Baseline and 5 weeks ]
  • Quality of Life (QOL) Outcome: QOL 1 (change in the 39-Item Parkinson's Disease) [ Time Frame: Baseline and 5 weeks ]
  • Mechanistic Outcome: Neurophysiology 1 (change in motor beta and gamma power using Magnetoencephalography) [ Time Frame: Baseline and 5 weeks ]
  • Mechanistic Outcome: Neurophysiology 2 (change in auditory-motor functional connectivity using Magnetoencephalography) [ Time Frame: Baseline and 5 weeks ]

Central Contacts and Locations

Locations

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jan 3, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-01-03.