NMT for Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Neurologic Music Therapy for Enhancing Fine Motor Control in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03049033
• Other study ID #: 16-2308
• Secondary ID: K01AT009894
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: Lucas Lattanzio, BA
• Phone: 303.724.2205
• Email: Lucas.Lattanzio[@]CUAnschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Outcome: Motor 1 (change in the Grooved Pegboard Test)	First motor outcome will be a change in the Grooved Pegboard Test.	Baseline and 5 weeks
Primary	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.	Baseline and 5 weeks
Primary	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.	Baseline and 5 weeks
Primary	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	Baseline and 5 weeks
Secondary	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.	Baseline and 5 weeks
Secondary	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.	Baseline and 5 weeks
Secondary	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 .	Baseline and 5 weeks
Secondary	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.	Baseline and 5 weeks