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NMT for Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurologic Music Therapy
Occupational Therapy
Music Supported Therapy
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Colorado DenverRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

No Intervention

Active Comparator

Arm Label

Neurologic Music Therapy (NMT)

Occupational Therapy (OT)

Waitlist Control

Music Supported Therapy (MST)

Arm Description

Neurologic Music Therapy is a 5-week intervention using different musical instruments and auditory cues to specifically improve fine motor movements.

Standard of care occupational therapy uses traditional motor training.

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.

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

Outcomes

Primary Outcome Measures

Clinical Outcome: Motor 1 (change in the Grooved Pegboard Test)
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)
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)
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)
Our second neurophysiology outcome will be a change in auditory-motor functional connectivity using Magnetoencephalography

Secondary Outcome Measures

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.
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.
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 .
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.

Full Information

First Posted
February 2, 2017
Last Updated
April 13, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03049033
Brief Title
NMT for Parkinson's Disease
Official Title
Neurologic Music Therapy for Enhancing Fine Motor Control in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neurologic Music Therapy (NMT)
Arm Type
Experimental
Arm Description
Neurologic Music Therapy is a 5-week intervention using different musical instruments and auditory cues to specifically improve fine motor movements.
Arm Title
Occupational Therapy (OT)
Arm Type
Active Comparator
Arm Description
Standard of care occupational therapy uses traditional motor training.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Music Supported Therapy (MST)
Arm Type
Active Comparator
Arm Description
Music Supported Therapy uses musical instruments to train fine motor movements.
Intervention Type
Other
Intervention Name(s)
Neurologic Music Therapy
Intervention Description
Neurologic Music Therapy uses rhythms to change brain activity and function.
Intervention Type
Other
Intervention Name(s)
Occupational Therapy
Intervention Description
Occupational Therapy uses traditional motor training.
Intervention Type
Other
Intervention Name(s)
Music Supported Therapy
Intervention Description
Music Supported Therapy uses musical instruments to train fine motor movements.
Primary Outcome Measure Information:
Title
Clinical Outcome: Motor 1 (change in the Grooved Pegboard Test)
Description
First motor outcome will be a change in the Grooved Pegboard Test.
Time Frame
Baseline and 5 weeks
Title
Quality of Life (QOL) Outcome: QOL 1 (change in the 39-Item Parkinson's Disease)
Description
First QOL outcome will be a change in the 39-Item Parkinson's Disease Questionnaire.
Time Frame
Baseline and 5 weeks
Title
Mechanistic Outcome: Neurophysiology 1 (change in motor beta and gamma power using Magnetoencephalography)
Description
Our first mechanistic outcome will be a change in cortical motor beta and gamma power using Magnetoencephalography.
Time Frame
Baseline and 5 weeks
Title
Mechanistic Outcome: Neurophysiology 2 (change in auditory-motor functional connectivity using Magnetoencephalography)
Description
Our second neurophysiology outcome will be a change in auditory-motor functional connectivity using Magnetoencephalography
Time Frame
Baseline and 5 weeks
Secondary Outcome Measure Information:
Title
Clinical Outcome: Motor 2 (change in the Unified Parkinson Disease Rating Scale Part III)
Description
Secondary motor outcome will be a change in the Unified Parkinson Disease Rating Scale Part III.
Time Frame
Baseline and 5 weeks
Title
Clinical Outcome: Motor 3 (change in the Finger-Thumb opposition from the Neurological Evaluation Scale)
Description
Secondary motor outcome will be a change in the Finger-Thumb opposition from the Neurological Evaluation Scale.
Time Frame
Baseline and 5 weeks
Title
Quality of Life (QOL) Outcome: QOL 2 (change in the Clinical Global Impression - Improvement Scale)
Description
Second QOL outcomes will be a change in the Clinical Global Impression - Improvement Scale .
Time Frame
Baseline and 5 weeks
Title
Quality of Life (QOL) Outcome: QOL 3 (change in the Hospital Anxiety and Depression Scale)
Description
Second QOL outcomes will be a change in the Hospital Anxiety and Depression Scale.
Time Frame
Baseline and 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucas Lattanzio, BA
Phone
303.724.2205
Email
Lucas.Lattanzio@CUAnschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Buard, PhD
Phone
303.724.5973
Email
Isabelle.Buard@CUAnschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Buard, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas Lattanzio, BA
Phone
303-724-2205
Email
Lucas.Lattanzio@CUAnschutz.edu
First Name & Middle Initial & Last Name & Degree
Isabelle Buard, PhD
Phone
303-724-5973
Email
Isabelle.Buard@CUAnschutz.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
34454592
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.
Results Reference
derived

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NMT for Parkinson's Disease

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