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NMT for Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03049033
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Neurologic Music Therapy Other: Occupational Therapy Other: Music Supported Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurologic Music Therapy for Enhancing Fine Motor Control in Parkinson's Disease
Actual Study Start Date : April 26, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Neurologic Music Therapy
Neurologic Music Therapy uses rhythms to change brain activity and function.

Active Comparator: Occupational Therapy (OT)
Standard of care occupational therapy uses traditional motor training.
Other: Occupational Therapy
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.
Other: Music Supported Therapy
Music Supported Therapy uses musical instruments to train fine motor movements.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 .

  4. 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.



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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049033


Contacts
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Contact: Nicola Haakonsen 303.724.6351 Nicola.Haakonsen@ucdenver.edu
Contact: Isabelle Buard, PhD 303.724.5973 Isabelle.Buard@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Nicola Haakonsen    303-724-6351    Nicola.Haakonsen@ucdenver.edu   
Contact: Isabelle Buard, PhD    303-724-5973    Isabelle.Buard@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Isabelle Buard, PhD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03049033     History of Changes
Other Study ID Numbers: 16-2308
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases