NMT for Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT03049033
• Recruitment Status: Recruiting
• First Posted: February 9, 2017
• Last Update Posted: October 19, 2020
• Sponsor: University of Colorado, Denver
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): University of Colorado, Denver

Tracking Information

• First Submitted Date: February 2, 2017
• First Posted Date: February 9, 2017
• Last Update Posted Date: October 19, 2020
• Actual Study Start Date: April 26, 2017
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 15, 2018)

• Clinical Outcome: Motor 1 (change in the Grooved Pegboard Test) [ Time Frame: Baseline and 5 weeks ]
  First motor outcome will be a change in the Grooved Pegboard Test.
• Quality of Life (QOL) Outcome: QOL 1 (change in the 39-Item Parkinson's Disease) [ Time Frame: Baseline and 5 weeks ]
  First QOL outcome will be a change in the 39-Item Parkinson's Disease Questionnaire.
• Mechanistic Outcome: Neurophysiology 1 (change in motor beta and gamma power using Magnetoencephalography) [ Time Frame: Baseline and 5 weeks ]
  Our first mechanistic outcome will be a change in cortical motor beta and gamma power using Magnetoencephalography.
• Mechanistic Outcome: Neurophysiology 2 (change in auditory-motor functional connectivity using Magnetoencephalography) [ Time Frame: Baseline and 5 weeks ]
  Our second neurophysiology outcome will be a change in auditory-motor functional connectivity using Magnetoencephalography

Original Primary Outcome Measures (submitted: February 8, 2017)

• Clinical Outcome: Motor 1 (change in the Grooved Pegboard Test) [ Time Frame: Baseline and 5 weeks ]
  First motor outcome will be a change in the Grooved Pegboard Test.
• Quality of Life (QOL) Outcome: QOL 1 (change in the 39-Item Parkinson's Disease) [ Time Frame: Baseline and 5 weeks ]
  First QOL outcome will be a change in the 39-Item Parkinson's Disease Questionnaire.
• Clinical Outcome: Motor2 (change in the Unified Parkinson Disease Rating Scale Part III) [ Time Frame: Baseline and 5 weeks ]
  Second motor outcome will be a change in the Unified Parkinson Disease Rating Scale Part III.
• Quality of Life (QOL) Outcome: QOL2 (change in the Clinical Global Impression - Improvement Scale) [ Time Frame: Baseline and 5 weeks ]
  Second QOL outcome will be a change in the Clinical Global Impression - Improvement Scale.

Current Secondary Outcome Measures (submitted: March 15, 2018)

• Clinical Outcome: Motor 2 (change in the Unified Parkinson Disease Rating Scale Part III) [ Time Frame: Baseline and 5 weeks ]
  Secondary motor outcome will be a change in the Unified Parkinson Disease Rating Scale Part III.
• Clinical Outcome: Motor 3 (change in the Finger-Thumb opposition from the Neurological Evaluation Scale) [ Time Frame: Baseline and 5 weeks ]
  Secondary motor outcome will be a change in the Finger-Thumb opposition from the Neurological Evaluation Scale.
• Quality of Life (QOL) Outcome: QOL 2 (change in the Clinical Global Impression - Improvement Scale) [ Time Frame: Baseline and 5 weeks ]
  Second QOL outcomes will be a change in the Clinical Global Impression - Improvement Scale .
• Quality of Life (QOL) Outcome: QOL 3 (change in the Hospital Anxiety and Depression Scale) [ Time Frame: Baseline and 5 weeks ]
  Second QOL outcomes will be a change in the Hospital Anxiety and Depression Scale.

Original Secondary Outcome Measures (submitted: February 8, 2017)

• Mechanistic Outcome: Neurophysiology1 (change in beta and gamma synchrony using Magnetoencephalography) [ Time Frame: Baseline and 5 weeks ]
  Our first neurophysiology outcome will be a change in beta and gamma synchrony using Magnetoencephalography.
• Mechanistic Outcome: Neurophysiology2 (change in brain connectivity between auditory and motor regions using Magnetoencephalography) [ Time Frame: Baseline and 5 weeks ]
  Our second neurophysiology outcome will be a change in brain connectivity between auditory and motor regions using Magnetoencephalography.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: NMT for Parkinson's Disease
• Official Title: Neurologic Music Therapy for Enhancing Fine Motor Control in Parkinson's Disease
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Parkinson Disease

Intervention

• Other: Neurologic Music Therapy
  Neurologic Music Therapy uses rhythms to change brain activity and function.
• Other: Occupational Therapy
  Occupational Therapy uses traditional motor training.
• Other: Music Supported Therapy
  Music Supported Therapy uses musical instruments to train fine motor movements.

Study 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.
  Intervention: Other: Neurologic Music Therapy
• Active Comparator: Occupational Therapy (OT)
  Standard of care occupational therapy uses traditional motor training.
  Intervention: Other: Occupational Therapy
• 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.
  Intervention: Other: Music Supported Therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 7, 2018): 100
• Original Estimated Enrollment (submitted: February 8, 2017): 80
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Lucas Lattanzio, BA; 303.724.2205; Lucas.Lattanzio@CUAnschutz.edu

Contact: Isabelle Buard, PhD; 303.724.5973; Isabelle.Buard@CUAnschutz.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03049033
• Other Study ID Numbers: 16-2308
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

De-identified data will be made available to the scientific community upon request.

Data sharing will include motor tests, questionnaires and MEG raw data.

• Responsible Party: University of Colorado, Denver
• Study Sponsor: University of Colorado, Denver
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Isabelle Buard, PhD; University of Colorado, Denver

• PRS Account: University of Colorado, Denver
• Verification Date: October 2020