Clinical trial NCT03049033: NMT for Parkinson's Disease
Official title: Neurologic Music Therapy for Enhancing Fine Motor Control in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2017-02-09
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Outcome: Motor 1 (change in the Grooved Pegboard Test)
timeFrame: Baseline and 5 weeks
measure: Quality of Life (QOL) Outcome: QOL 1 (change in the 39-Item Parkinson's Disease)
timeFrame: Baseline and 5 weeks
measure: Mechanistic Outcome: Neurophysiology 1 (change in motor beta and gamma power using Magnetoencephalography)
timeFrame: Baseline and 5 weeks
measure: Mechanistic Outcome: Neurophysiology 2 (change in auditory-motor functional connectivity using Magnetoencephalography)
timeFrame: Baseline and 5 weeks
Secondary outcomes:
measure: Clinical Outcome: Motor 2 (change in the Unified Parkinson Disease Rating Scale Part III)
timeFrame: Baseline and 5 weeks
measure: Clinical Outcome: Motor 3 (change in the Finger-Thumb opposition from the Neurological Evaluation Scale)
timeFrame: Baseline and 5 weeks
measure: Quality of Life (QOL) Outcome: QOL 2 (change in the Clinical Global Impression - Improvement Scale)
timeFrame: Baseline and 5 weeks
measure: Quality of Life (QOL) Outcome: QOL 3 (change in the Hospital Anxiety and Depression Scale)
timeFrame: Baseline and 5 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Isabelle Buard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.